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BREAST: NEOADJUVANT: ER+: Post-menopausal: DOD 16-1042

Randomized phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/HER2- breast cancer

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Malignancy

Breast cancer, Hormone receptor positive breast cancer, locally advanced BC

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Enzalutamide and fulvestrant

Drug Class

Androgen receptor inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

University of Colorado, Department of Defense

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • ER positive breast cancer
  • Tumor stage at least T2
  • Plan to receive local surgery
  • Post-menopausal or if premenopausal will need to have concurrent ovarian suppression
  • ECOG PS 0-2
  • No history of seizures
  • Not on full dose anticoagulation
  • No prior treatment with anti-androgen agents
  • No history of CNS metastases
BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Neratinib

Drug Class

HER2 targeted small molecule

PI

Greg Vidal, MD, PhD

Sponsor

West Cancer Center, Puma Biotechnology, Celcuity

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
  • ER/PR <10%, HER2 negative
  • ECOG PS 0-1
  • ANC >1200, Hgb >10, Plt >100,000
  • Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
  • No T3 or T4 tumors
  • No definitive surgical treatment performed yet
  • No evidence of metastatic disease
  • No prior history of ipsilateral DCIS or breast cancer
  • No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
  • No other malignancies within 2 years prior
  • No active cardiac disease
  • No uncontrolled hypertension
  • No known HIV/HBV/HCV
  • No neuropathy grade >=2
Breast: Post-Mastectomy: Hypofractionated Radiotherapy: RT CHARM

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

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Malignancy

Breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Hypofractionated radiotherapy

Drug Class

Radiation

PI

Noam VanderWalde, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Invasive ductal, invasive lobular, tubular

Key Eligibility Criteria Details
  • Invasive breast cancer (ductal, lobular, tubular, mammary, medullary)
  • If received neoadjuvant therapy, pre treatment staging must have N1 or N2 disease pre-chemo or are T3N0
  • If did not receive neoadjuvant, must be T0N1-2a, T1N1-2a, T2N1-2a, or T3N0-2a.
  • No prior therapeutic radiation to the chest, neck, or axilla
  • No prior history of ipsilateral breast cancer
    • DCIS or LCIS are allowed
  • Negative margins following mastectomy
  • No significant post mastectomy complications in the ipsilateral breast requiring unplanned re-operation or admission for IV antibiotics.
    • Reoperation for margins or lymph node dissection is allowed
  • Radiation oncologist is NOT planning to use a chest wall/scar boost
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • No co-existing medical conditions with a life expectancy <5 years
  • ECOG PS 0-1
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; axillary dissection vs XRT; “Alliance-011202”

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

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Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

N/A

Drug Class

N/A

PI

Richard Fine, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Node-positive any histology

Key Eligibility Criteria Details
  • Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
  • No inflammatory breast cancer
  • No other malignancy within 5 years
  • Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
  • Must have documented ER/PR/HER2 status before neoadjuvant therapy
  • Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
  • Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
  • HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
  • Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
  • No neoadjuvant endocrine or radiation therapy
  • No history of prior breast cancer
  • ECOG PS 0-1
  • Must complete surgery within 56 days of finish of neoadjuvant therapy
  • At least 1 sentinel lymph node identified intra-operatively with at least micromets
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; standard vs comprehensive XRT; “NSABP B-51"
A randomized phase III clinical trial evaluating post-mastectomy chestwall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

regional nodal irradiation

Drug Class

N/A

PI

Noam VanderWalde, MD

Sponsor

NSABP Foundation

Path

Node positive prior to surgery, pathologically node negative at surgery

Key Eligibility Criteria Details
  • Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).  Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)

  • Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.

  • HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)

  • Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen

  • For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization

  • Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.

  • At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer

  • ECOG PS 0-1

BREAST: ADJUVANT: ER/PR+: CDK4/6: NATALEE

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE

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Malignancy

Breast cancer, Invasive breast cancer, BC

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Aduvant

Investigational Agent

Ribociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

ER or PR positive (HR+), adenocarcinoma

Key Eligibility Criteria Details
  • Histologically confirmed unilateral adenocarcinoma of the breast
  • Positive for ER and/or PgR
  • HER2 negative
  • Patient has had surgical resection where tumor was removed completely with negative margins
  • Anatomic Stage II or III
  • Completed neoadjuvant or adjuvant chemotherapy (if indicated)
  • Completed adjuvant XRT (if indicated)
  • Plan to treat pt with endocrine tx for 5 years
  • No prior CDK4/6 inhibitor
  • No prior tamoxifen, ralixofene, or AIs for chemoprevention
  • No prior tx with anthracycline at cumulative doses of 450mg/m2 or more
  • No distant metastatic disease
  • No other cancer within 2 years of study enrollment
  • No known HIV/HBV/HCV
  • No clinically significant cardiac disease
BREAST: Adjuvant: ER/PR+: HER2-; \"e3\"

Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk hormone receptor-positive and HER2/Neu negative breast cancer. E3 Breast cancer study- evaluating everolimus with endocrine therapy

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Malignancy

Breast, early breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

everolimus

Drug Class

MTOR inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Southwest Oncology Group

Path

Key Eligibility Criteria Details

High risk early breast cancer as defined as follows:

  • Post adjuvant chemo withTumor >2cm, N0, Oncotype Dx >25 or
  • Post adjuvantchemo with 1-3 positive nodes, OncDx >25 or
  • Post adjuvant chemo with >3 positive nodes or
  • Post neoadjuvant chemo with >3 positive nodes

HER2 negative, ER/PR positive
Completed standard neoadjuvant or adjuvant taxane or anthracycline therapy
No prior receipt of MTOR inhibitors
ECOG PS 0-2
Fasting cholesterol <300, TG <2.5x ULN
HIV positive allowed if controlled CD4 count and NOT on ART

BREAST: METASTATIC: TNBC: 1st Line: IPATUNITY-170

A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

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Malignancy

Breast, TNBC, Triple negative breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Ipatasertib, atezolizumab, paclitaxel

Drug Class

PI3-kinase inhibitor, PD-L1 inhibitor, taxane

PI

Greg Vidal, MD, PhD

Sponsor

Hoffmann-La Roche

Path

ER negative, PR negative, HER2 negative adenocarcinoma

Key Eligibility Criteria Details
  • Triple-negative adenocarcinoma of the breast either unresectable with curative intent and either locally advanced or metastatic 
    • Most recent biopsy shows ER and PR levels <1%, HER2 <3+
  • No prior systemic therapy for metastatic disease
    • No chemotherapy for early disease in last 12 months
  • Appropriate candidate for paclitaxel monotherapy if PD-L1 negative (or unknown)
  • Appropriate candidate for paclitaxel and atezolizumab if PD-L1 status is positive
  • Appropriate lab values
    • CBC: ANC >/= 1500, Hgb >/= 9, plts >/= 100
    • Chem: CrCl >/=50, Alb >/=3, Gluc </=150 and HgbA1c </= 7.5%, ALT/AST </= 2.5x ULN
    • PT/PTT </= 1.5x ULN
  • No known HIV/HBV/HCV
  • No LVEF <50%
  • No requirement for steroids >10mg prednisone or equivalent
  • No known CNS disease or spinal cord mets
  • No other malignancies in last 5 years except in-situ cervical, non-melanoma skin, or stage I endometrial
  • No history of diabetes
  • No Grade 2 or higher neuropathy
  • No active or history of autoimmune disease
BREAST: METASTATIC: TNBC: 2nd-3rd Line: LEAP-005-TNBC

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Temporarily On Hold

Line Of Therapy

2nd line or 3rd line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

TNBC

Key Eligibility Criteria Details
  • Have received one or 2 prior lines of therapy
  • Must have been treated with taxane and antrhacycline in the past
  • Adjuvant/neoadjuvant tx not considered line of therapy unless progressed within 6 months
  • LDH <2.0 ULN
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
BREAST: METASTATIC: TNBC: PHASE 1: 2nd/3rd LINE: MK-5890-01-ARM2A

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd line

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Must have measurable disease by RECIST 1.1
  • Diagnosis of TNBC
  • Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
  • Prior therapy should have included anthracycline and/or taxane
  • LDH must be <2x ULN at screening
  • May be PD-L1 treatment refractory (number capped)
  • ECOG PS 0-1
  • No 2nd malignancy within 2 years
  • No active CNS involvement
  • No history of interstitial lung disease
  • No active pneumonitis or history of non-infectious pneumonitis that required steroids
  • No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
  • No known HIV, HBV, HCV
  • No need for steroids at dose of greater than 10mg prednisone or equivalent daily
  • No recent history of substance abuse
BREAST: METASTATIC: HER2+: Prior T-DM1: DESTINY-Breast02

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

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Malignancy

Breast Cancer, Invasive breast Cancer, BC, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line or 3rd line (prior T-DM1)

Investigational Agent

Trastuzumab deruxtecan (DS8201a)

Drug Class

HER-2 targeted ADC

PI

Greg Vidal, MD, PhD

Sponsor

Daiichi Sankyo, Inc.

Path

HER2 positive

Key Eligibility Criteria Details
  • Histologically confirmed unresectable or metastatic breast cancer
  • HER-2 positive (HER2+) by ASCO-CAP guidelines and confirmed by central lab
  • Previously treated with T-DM1
  • Progression following last treatment (cannot go on after stopping treatment for toxicity alone)
  • No prior capecitabine
  • No history of insterstitial lung disease or pneumonitis requiring steroids
  • No active CNS disease
BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: ESR1 mutant: SMX 18001

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation

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Malignancy

Breast cancer, invasive breast cancer, BC, hormone receptor positive BC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line or later endocrine tx

Investigational Agent

Lasofoxifene

Drug Class

SERM

PI

Lee Schwartzberg, MD

Sponsor

Sermonix Pharmaceuticals LLC

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • Postmenopausal women with locally advanced or metastatic breast cancer
  • Progression on an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor
  • Demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in metastatic setting)
  • Measurable or non-measurable disease allowed
  • One of the following ESR point mutations in cell-free DNA:
    • Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N
  • May have received up to one chemothearpy regimen in adjuvant or neoadjuvant setting
  • ECOG PS 0-1
  • No prior use of any SERM with following exception
    • OK if tamoxifen previously used in adjuvant setting with relapse at least 1 year after stopping tamoxifen
  • No prior everolimus or PI3K inhibitors
  • No presence of CNS disease
  • No immediate need for chemotherapy
  • No HIV, HBV, HCV
  • No prior malignancy in last 5 years except non-melanoma skin cancer or early stage cervical cancer
  • No uncontrolled HTN
  •  
BREAST: METASTATIC: ER/PR+: HER2 neg: No prior taxane: CONTESSA 2

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

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Malignancy

Breast cancer, invasive breast cancer, BC, hormone receptor positive BC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st line chemo (most likely)

Investigational Agent

tesetaxel

Drug Class

oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER/PR positive, HER2 negative

Key Eligibility Criteria Details
  • Pathologically confirmed locally advanced unresectable or metastatic breast cancer
  • HER2 negative (-) disease
  • Hormone receptor (ER and/or PR) positive (+)
  • Measurable disease
  • CNS disease is allowed provided that patient is neurologically stable on maximum dose of 4mg dexamethosone, no leptomeningeal disease, and no local-directed CNS treatmnt is immediately necessary
  • ECOG PS 0-2
  • No limit on number of prior endocrine therapies
  • No more than 2 prior lines of chemotherapy
  • No prior treatment with either capecitabine or any taxane
  • No other malignancies within 5 years except with discussion with medical monitor
  • No HIV, HBV, HCV
  • No Grade 2 or higher neuropathy
  •  
BREAST: METASTATIC: HER2 negative: 1st Line: Older Adults: CONTESSA TRIO >65

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast, Metastatic Breast Cancer, MBC,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Tesetaxel

Drug Class

Oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

HER2 negative (Any ER or PR status)

Key Eligibility Criteria Details
  • Age 65 or older
  • Locally advanced breast cancer not considered curable by surgery or radioation or metastatic breast cancer
  • Measurable Disease
  • Brain mets are allowed
  • ECOG PS 0-2
  • If ER/PR+, must have received prior therapy with endocrine therapy (+/- CDK 4/6 therapy).
  • Any number of prior endocrine or targeted therapies are permitted
  • No prior chemotherapy for metastatic disease
  • No known HIV/HBV/HCV
  • No Grade >1 neuropathy
BREAST: METASTATIC: TNBC: 1st Line: CONTESSA TRIO

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast cancer, triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Tesetaxel, nivolumab, pembrolizumab, atezolizumab

Drug Class

oral taxane, PD-1 or PD-L1 inhibitors

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • ER -, PR-, HER2 - biopsy proven breast cancer
  • Locally advanced (not curable by surgery or radiation) or metastatic
  • No prior chemotherapy for metastatic disease
  • (Neo)Adjuvant therapy allowed if disease free interval of at least 12 months after completion
  • No prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors
  • Tissue available for PD-1 level determination
  • ECOG PS 0-2
  • No known HIV/HBV/HCV
  • No history of active autoimmune disease
  • No Grade 2 or higher neuropathy
BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 1st Line: MORPHEUS

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo

Drug Class

PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

ER- (negative), PR- (negative), HER2- (negative)

Key Eligibility Criteria Details
  • Triple negative metastatic breast cancer
  • 2nd line
  • ECOG PS 0-2
  • No prior treatment with any study agents
  • No history of autoimmune disease
  • Presence of measurable disease
  • No symptomatic or untreated CNS disease
BREAST: METASTATIC: ER/PR+: 3rd Line or later: Sacituzumab: IMMU-132-09

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens

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Malignancy

Breast, ER positive breast cancer, MBC, PR positive breast cancer, HER2 negative breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd Line or greater

Investigational Agent

Sacituzumab govitecan

Drug Class

ADC for Trop-2

PI

Lee Schwartzberg, MD

Sponsor

Immunomedics, Inc

Path

ER/PR +, HER2-

Key Eligibility Criteria Details
  • Hormone receptor positive, HER2 negative metastatic breast cancer
  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic therapies including;
    • At least 1 prior anticancer hormonal treatment
    • At least 1 CDK4/6 in the metastatic settting
  • Eligible to receive at least 1 of the following chemotherapies; eribulin, capecitabine, gemcitabine, vinorelbine
  • Disease progression after most recent therapy
  • No potential therapy available with curative intent (e.g. surgery)
  • No prior Topo1 inhibitors
MOLECULARLY TARGETED: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

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Malignancy

Solid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Following all effecive therapy (late line)

Investigational Agent

Pemigatinib

Drug Class

FGFR inhibitor

PI

Dan Vaena, MD

Sponsor

Incyte Corporation

Path

FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation

Key Eligibility Criteria Details
  • Metastatic or surgically unresectable solid tumor
  • Measurable disease
  • Documentation of an FGFR1-3 gene mutation or translocation
  • At least 1 prior line of therapy with progression
  • No other therapy available likely to provide clinical benefit
  • ECOG PS 0-2
  • No other FGFR inhibitors within last 6 months
  • No clinically significant corneal or retinal disorder
  • No untreated CNS disease (except primary brain cancer)
  • No additional malignancy at current time requiring active treatment
  • No history of calcium or phosphate disorder or systemic mineral imbalance
  • No clinically significant cardiac disease
  • No active HBV/HCV
  • No known HIV
MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification

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Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Key Eligibility Criteria Details
  • Histologically confirmed cancer for which no curative therapy exists
  • Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
    • Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
  • At least one measurable or evaluable lesion
  • LVEF >/=50%
  • ECOG PS 0-2
  • No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
  • No symptomatic or unstable brain mets (stable are allowed)
  • No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
  • No uncontrolled cardiac disease
  • No chronic diarrheal disorder
MOLECULARLY TARGETED: PIK3CA mutations: \"PMT4979g\"

An open-label, phase I/II, dose-escalation study evaluating the safety and tolerability of GDC-0032 in patients with locally advanced or metastatic solid tumors or non-Hodgkin's lymphoma and in combination with endorcrine therapy in patients with locally advaned or metastatic hormone receptor-positive breast cancer.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder, Head and Neck, Gastric, TNBC, Ovarian

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

> or = 2nd line

Investigational Agent

taselisib (GDC-0032)

Drug Class

PI3 kinase delta inhibitor

PI

Ari VanderWalde, MD

Sponsor

Hoffman-La Roche

Path

PIK3CA mutation

Key Eligibility Criteria Details
  • Advanced solid malignancies with PIK3CA mutations (see "malignancies" tab for current eligible disease states)
  • No  untreated or active CNS mets
  • No diabetes requiring active treatment
  • No active CHF or ventricular arryhtmias requiring treatment
  • Measurable disease via RECIST 1.1
  • ECOG PS 0-1
  • No O2 requirements
  • No XRT within previous 2 weeks (for bony mets) or 4 weeks for all other reasons
  • No requirements for immunosuppression

 

 

 

ADVANCED SOLID TUMORS: PHASE 1: OBI-888

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Colon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-888

Drug Class

Anti-globo-H antibody

PI

Axel Grothey, MD

Sponsor

OBI Pharma

Path

Globo-H overexpression

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed patients with advanced or metastatic solid tumors
  • Measurable disease
  • Must have been treated with all estrablished standard-of-care therapy or determined by the physician that such established therapy is not sufficiently efficacious, or patients have declined to receive standard of care therapy
  • ECOG PS 0-1
  • Must have Globo-H overexpression as measured by central lab
  • No known active autoimmune or inflammatory disease
  • Not receiving systemic steroids of >10mg prednisone per day or equivalent
ADVANCED TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

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Malignancy

Lung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any line as long as appropriate to give study acceptable chemo in combination

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

Key Eligibility Criteria Details
  • Advanced solid tumor or relapsed/refractory lymphoma OR
    • eligible to receive single agent pembrolizumab as standard-of-care OR
    • eligible to receive single-agent docetaxel as standard of care OR
      ​advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
  • Measurable disease
  • ECOG PS 0-1
  • No history of severe autoimmune disease
  • Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy
METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, metastatic solid malignancy
  • Has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior PD-1/PD-L1 allowed
  • No other malignancy within 2 years prior
  • No active autoimmune disease requiring systemic therapy within last 2 years
  • No chronic steroids or immunosuppressants.
ADVANCED TUMORS: PHASE 1 (ESCALATION): PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

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Malignancy

Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

BMS 986258

Drug Class

TIM-3 antibody

PI

Dan Vaena, MD

Sponsor

Bristol Myers Squibb

Path

Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • No active CNS disease (controlled brain mets are allowed)
  • Must have one of the five malignancies below
    • Clear-cell RCC
    • Triple-negative Breast Cancer
    • Squamous cell carcinoma of the head and neck
    • Colorectal cancer
    • Non-small cell lung cancer
  • No other malignancies within 2 years
  • No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
  • No severe autoimmune reactions to immunotherapy
  • No need for active steroid therapy
  • No significant cardiac disease
  • No chronic hepatitis
  • No active interstitial lung disease
  • RCC specific eligibility criteria
    • Previously received one or two anti-VEGFR therapies
    • No more than 3 total prior systemic tx in metastatic setting
    • Must have evidence of progression on or after last treatment received and within 6 months of starting study
  • CRC specific eligibilty criteria
    • Must have received and progressed on at least 1 standard therapy for metastatic disease
    • Must have known MSI status
  • NSCLC specific eligibility criteria
    • Must have progressed on or been refractory to platinum doublet
    • Must have known EGFR, ALK, ROS1 status.
      • Those with EGFR or ALK alterations must have previously received TKI therapy
  • SCCHN specific eligibility criteria
    • Not amenable ot local therapy with curative intent
    • Must have progressed on or been intolerant of platinum containing regimen
  • TNBC specific eligibility criteria
    • Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane
BREAST: Metastatic: TNBC: 2nd or later line; Phase 1; "D4884C00001 TNBC"
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd, 3rd, 4th line

Investigational Agent

Tremelimumab (and Durvalumab)

Drug Class

anti CTLA-4 antibody (and anti PD-L1 antibody)

PI

Ari VanderWalde, MD, MPH

Sponsor

AstraZeneca

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details

    • Metastatic Triple-Negative Breast Cancer

    • Failed at least one line of therapy in metastatic setting

    • No more than 3 previous lines of therapy in the metastatic setting

    • Measurable disease

    • No prior autoimmune or inflammatory disorders

    • No CNS involvement or history of spinal cord compression

BREAST: Metastatic; BRCA mutant; "EMBRACA"

A phase 3, open-label, randomized, parallel, 2-arm, multi-center study of BMN 673 versus physician's choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received no more than 2 prior chemotherapy regimens for metastatic disease (EMBRACA Study)

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Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st line2nd line3rd line

Investigational Agent

BMN 673

Drug Class

PARP inhibitor

PI

Lee Schwartzberg, MD

Sponsor

BioMarin Pharmaceutical

Path

BRCA 1 mutant or BRCA 2 mutant

Key Eligibility Criteria Details

Locally advanced or metastatic breast CA
BRCA 1 or 2 germline mutation
Appropriate for single-agent cytotoxic chemotherapy
Prior receipt of anthracycline and/or taxane
No more than 2 prior chemo regimens for metastatic disease
ECOG 0-1
No prior platinum treatment for metastatic disease
No active CNS mets
Adequate organ function

ADVANCED TUMORS: Metastatic; PD-1 monotherapy; “Checkmate 627”

An open label phase 2 multi-cohort trial of nivolumab in advanced or metastatic malignancies

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Malignancy

Histiocytosis, Lynch Syndrome Cancer (non-CRC), Medullary Thyroid, Merkel Cell, Abdominal Mesothelioma, Nasopharyngeal, Small cell (non-lung), Penile, Testicular, Thyroid (papillary or follicular), Thyroid (anaplastic-1st line), Uterine Sarcoma, Vulvar Cancer, Small bowel, Adrenocortical, Appendix, endocervical, adenoid-cystic like (HPV+), Cutaneous Adenocarcinoma, Schwannoma

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line or later (unless no primary therapy standard)

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Bristol-Myers Squibb

Path

tumor type specific

Key Eligibility Criteria Details
  • Measurable disease required
  • ECOG PS <1
  • Brain mets allowed but must not be active, cannot require steroids, have at least one measurable lesion outside of brain
  • Excluded tumors:
    • No Pancreatic
    • No endometrial with ER>10%
    • No ovarian
    • No breast
    • No esophageal
    • No gastric
    • No glioma
    • No hepatocellular carcinoma
    • No lymphoma (except primary CNS lymphoma)
    • No leukemia
    • No melanoma
    • No MDS
    • No lung cancer
    • No renal cell
    • No bladder
  • Must not have had other cancer within 2 years
  • No prior PD-1/L-1 or CTLA-4 therapy
  • No autoimmune disease
  • No active steroids
  • No known HIV, HBV, or HCV
  • See "malignancy" list for accepted tumor types
ADVANCED SOLID TUMORS: Phase 1; HER2+; \"FS10214100\"

Phase I, two-part, multiple, ascending dose study of the anti-HER2 FCAB FS102 in breast, gastric, and other solid tumors

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Malignancy

z- Advanced Solid Tumors, Breast, Gastric, GE junction

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

After failure of all standard therapies

Investigational Agent

FS102

Drug Class

Bi-specific anti-HER2 antibody (Fcab)

PI

Daruka Mahadevan, MD, PhD

Sponsor

Bristol-Myers Squibb

Path

HER2 positiveadenocarcinoma

Key Eligibility Criteria Details

HER2+ adenocarcinoma (by FISH, regardless of IHC)
Unresectable or metastatic last line
ECOG PS 0-1
Limit of prior cumulative doxorubicin dose of 360mg/m2
No CNS disease
No history of prior cancer within last 3 years
No significant cardiac disease
No HIV, HBV, HCV

BREAST: METASTATIC: Triple Negative: 1st line or >2nd Line: “CX-839-007”

A multicenter phase 2 study of the glutaminase inhibitor CB-839 in combination with paclitaxel in patients with advanced triple negative breast cancer (TNBC) including patients of African ancestry and non-African ancestry

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Malignancy

Breast, Metastatic Breast Cancer, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

Cohorts 2 and 4- 1st line; Cohorts 1 and 3- 3rd line or higher

Investigational Agent

CB-839

Drug Class

Glutaminase Inhibitor

PI

Greg Vidal, MD

Sponsor

Calithera Biosciences, Inc.

Path

Triple negative

Key Eligibility Criteria Details
  • Females >18 years old

  • TNBC defined as ER/PR <1%, HER2 negative

  • ECOG PS 0-1

  • Labs within standard limits

  • No known CNS disease unless adequately treated with XRT or surgery and stable by symptoms for at least 2 months prior

  • No other malignancy within 3 years (except non-melanoma skin cancer or in situ cancers)

  • No unstable cardiac disease

  • No known sensitivity Cremaphor

  • Cohort 1- 3rd+ line in African ancestry

    • Must have received prior taxane for metastatic disease but not in most recent treatment

    • Adjuvant therapy counts as therapy if time to recurrence <12 months

  • Cohort 2- 1st line in African ancestry- no prior systemic tx for advanced disease

    • Adjuvant therapy only allowd if time to recurrence >12 mo

  • Cohort 3- 3rd+ line in non-African ancestry

    • Similar to Cohort 1

  • Cohort 4- 1st line in non-African ancestry

    • Similar to cohort 2

ADVANCED SOLID TUMORS: Phase 1; "I3Y-MC-JPBE"
Effects of CYP3A inhibition by clarithromycin on the pharmacokinetics of LY2835219 and its metabolites in cancer patients VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- Advanced Solid Tumors, Breast, Colon, Lung, Prostate, Sarcoma, Bladder, Kidney, Renal, Melanoma, Esophagus, Stomach, Head and Neck, Liver, Pancreatic

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any

Investigational Agent

LY2835219

Drug Class

CDK 4/6 Inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Eli Lilly and Company

Path

Any solid tumor

Key Eligibility Criteria Details
Metastatic solid tumors
ECOG PS 0-2
No symptomatic CNS disease
BREAST: ADJUVANT: ER/PR positive: MONARCH-E

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Hormone Receptor Positive, ER, PR

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Post adjuvant chemo, concurrent with endocrine therapy

Investigational Agent

Abemaciclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Eli Lilly and Company

Path

ER/PR positive (+) , HER2 negative (-)

Key Eligibility Criteria Details
  • Confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
  • Must have undergone definitive surgery of the primary breast tumor.
  • Must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
  • Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:

    • 4 or more positive axillary lymph nodes
    • Tumor size of at least 5 centimeters
    • Grade 3 defined as at least 8 points on the Bloom Richardson grading system
    • Ki-67 index by central analysis of ≥20% on untreated breast tissue
  • Must be randomized within 16 months from the time of definitive breast cancer surgery.
  • May receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
  • ECOG PS 0-1
  • No metastatic disease (including contralateral axillary lymph nodes) or node-negative disease.
  • No inflammatory breast cancer.
  • No previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago.
  • No other malignancy within 5 years
  • No concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
  • No prior endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
  • No history of venous thromboembolism (VTE).
BREAST: Neoadjuvant; HR+; HER2-; "neoMONARCH"
neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Early Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

Abemaciclib

Drug Class

CDK4/6 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Eli Lilly and Company

Path

ER positive (ER+) or PR positive (PR+) , HER2 negative

Key Eligibility Criteria Details

Postmenopausal adenocarcinoma of breast

Tumor >1cm in diameter

HR+, HER2-

Neoadjuvant endocrine monotherapy deemed to be suitable therapy

Suitability for baseline core biopsy

No bilateral breast cancer

No inflammatory breast cancer

No metastatic disease

No prior systemic therapy or XRT in same breast as being currently treated

No prior anti-estrogen therapy

BREAST: Adjuvant; HER2 negative; Vaccine; "PRESENT"
PRESENT: Prevention of recurrence in early-stage, node-positive breast cancer with low to intermediate HER2 expressions with NeuVax treatment VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Early Breast Cancer

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Post-definitive (neo)adjuvant therapy

Investigational Agent

Neuvax (Nelipepimut-S or E75)

Drug Class

anti-tumor vaccine, active specific immunotherapy

PI

Lee Schwartzberg, MD

Sponsor

Galena BioPharma

Path

HER2 1+ or 2+ (ISH negative) HLA-A2 or HLA-A3 haplotype

Key Eligibility Criteria Details

HER2- (IHC1+ or IHC2+/ISH-)HLA-A2 or HLA-A3 positive haplotype
T1-3
Node positive
Had ALND if SNB+ at definitive surgery
Completed neoadj or adj chemotherapy
Completed radiation therapy (if indicated)_
No autoimmune disease
No chronic steroid use
BREAST: Metastatic: Triple Negative; 1st line; "GO29227"
A randomized, phase II, multi-center, placebo-controlled study of ipatasertib (GDC-0068), an inhibitor of AKT, in combination with paclitaxel as front-line treatment for patients with metastatic triple-negative breast cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

1st

Investigational Agent

Ipatasertib

Drug Class

small molecule AKT inihibitor

PI

Greg Vidal, MD, PhD

Sponsor

Genentech, Inc.

Path

ER/PR negative, HER2 negative

Key Eligibility Criteria Details
          • Unresectable metastatic or locally advanced TNBC
          • Pre- or post-menopausal
          • ECOG PS 0-1
          • Tumor specimen (FFPE) must be available prior to randomization
          • Measurable disease per RECIST 1.1
          • No prior systemic anti-breast cancer therapy in metastatic or inoperable setting
          • No prior tx with AKT, PI3k, or mTOR inhibitors
          • No CNS disease
BREAST: Metastatic: Phase 1: Immunotherapy combination: “GO29831- Metastatic”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic HER2 positive breast cancer

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

1st line for HER2+, 1st-3rd line for HER2-

Investigational Agent

Atezolizumab

Drug Class

PD-L1 antibody

PI

Greg Vidal, MD

Sponsor

Hoffmann-La Roche

Path

Any HER2 status, Any ER status

Key Eligibility Criteria Details
  • Men or women

  • Metastatic or locally advanced or recurrent breast cancer

  • If HER2 negative, no more than two prior chemotherapy lines in metastatic disease and no prior anthracycline

  • Must have prior treatment with a taxane and trastuzumab in any setting

    • If treated in 2nd line or later, must have progressive disease since last regimen

    • If treated in 1st line metastatic, must have progression within 6 months of completing adjuvant therapy

  • Tumor specimen must be obtained after the most recent breast cancer systemic therapy

  • ECOG PS 0-2

  • Measurable disease

  • LVEF >50% by ECHO or MUGA

  • Adequate labs

  • No known CNS disease except for treated asymptomatic supratentorial mets with no need for active steroids

  • No leptomeningeal disease

  • No grade 2 or higher peripheral neuropathy
  • No history of autoimmune disease or need for current immunosuppressants
  • No HVB/HCV/HIV

 

BREAST: Neoadjuvant: Phase 1: HER2+: Immunotherapy combination: “GO29831- Neoadjuvant”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Breast Neoadjuvant, HER2+

Stage

Stage 2

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Neoadjuvant

Investigational Agent

Atezolizumab

Drug Class

PD-L1 antibody

PI

Greg Vidal, MD

Sponsor

Hoffmann-La Roche

Path

HER2 positive

Key Eligibility Criteria Details
  • Men or women

  • Primary tumor size >2cm

  • Stage at presentation cT2-cT4, cN0-cN3, cM0

  • HER2 positive disease (ISH positive and/or 3+ by IHC)

  • HLA-A2 positive (by central laboratory)

  • ECOG PS 0-2

  • Adequate lab tests

  • Baseline LVEF >50% by ECHO or MUGA

  • No prior systemic therapy for treatment or prevention of breast cancer

  • No history of DCIS unless >5 years prior to current diagnosis

  • No Grade 2 or higher peripheral neuropathy

  • No history of autoimmune disease, need for current immunosuppressants

  • No HBV/HCV/HIV

MOLECULARLY TARGETED: ALK alteration: METASTATIC: >/= 2nd Line: \"MY PATHWAY- ALK\"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, breast, CNS (GBM), Liver (HCC), Head and neck (SCCHN), colon, rectum (CRC) bladder, kidney (RCC), prostate, breast, gastric, pancreatic, melanoma (skin)

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line or greater

Investigational Agent

Alectinib

Drug Class

ALK inhibitor

PI

Ari VanderWalde

Sponsor

Genentech, Inc.

Path

ALK gene rearrangements (by NGS or FISH), ALK mutations (NGS), ALK copy number gain (NGS)

Key Eligibility Criteria Details
  • Metastatic solid tumor
  • ALK alterations as follows
    • ALK gene rearrangements by NGS or FISH using Vysis ALK Break Apart FISH Probe Kit
    • Activating non-synonymous mutations in and around the ALK kinase domain by NGS
    • ALK copy number gains by NGS
    • Patients with melanoma and high ALK expression by IHC
  • ECOG PS 0-2
  • No prior treatment with any ALK inhibitor
  • Following tumor types are not eligible
    • Non-small cell lung cancer (NSCLC)
    • Neuroblastoma
    • Childhood tumors
MOLECULARLY TARGETED: TMB-high: >/=2nd Line: MY PATHWAY- TMB

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2ndline or later

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech

Path

Solid tumor

Key Eligibility Criteria Details
  • PD-L1 copy number gain/amplification (likely available on Foundation only)
  • Patients with MSI-high
    • Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
  • Patients with dMMR
    • Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
  • Patients with total mutational burden (TMB) high
    • 10 mut/Mb per any CLIA certified test
  • Patients with alterations in DNA proofreading/repair genes
    • POLE mutations
    • POLD1 mutations
    • Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
  • If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
  • No metastatic non-small cell lung cancer (no NSCLC)
  • No metastatic urothelial carcinoma (no bladder cancer)
  • No MSI-high colorectal cancer
  • No history of autoimmune disease or immune deficiency
  • No HIV/HBV/HCV
  • No other malignancy within 5 years
  • No need for immunosuppressive medications (including steroids)
MOLECULARLY TARGETED: PTCH/SMO mut: Metastatic; >/= 2nd line; \"My Pathway- PTCH/SMO\"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Head and neck (SCCHN, oropharynx, larynx, hypopharyx, oral cavity); liver (hepatocellular, HCC); ovarian; colorectal (colon, CRC); esophageal, CNS (brain), breast, lung

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

Investigational Agent

Vismodegib

Drug Class

Hedgehog inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Path

Hedgehog activation mutations (PTCH loss of function, SMO gain of function)

Key Eligibility Criteria Details


Metastatic solid tumor
Loss of function mutation in PTCH or gain of function mutation in SMO
No basal cell CA, medulloblastoma, or SCLC2nd line or greater
ECOG PS 0-2
No prior treatment with any hedgehogdirected therapy
No active or untreated CNS metastastasis_

BREAST; Neoadjuvant;WT1+;"INDUCT"
VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer

Stage

Stage 2

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

GSK2302024A

Drug Class

WT1-A10 + AS15 Antigen-Specific Cancer Immunotherapeutic

PI

Lee Schwartzberg, MD

Sponsor

GSK (GlaxoSmithKline)

Path

WT1-positive Any ER/PR/HER2 Status

Key Eligibility Criteria Details
WT1 antigen expression (positive, +),
Stage II or Stage III,
ECOG 0-1,
LVEF >50%,
Normal organ function by labs,
No inflammatory breast CA,
No diagnosis by incisional bx,
No symptomatic autoimmune dz,
No immunosuppressive agents or prednisone >10mg/day,
No heparin or warfarin.__
ADVANCED SOLID TUMORS; Phase 1; BRAF mutation; roll-over; "114144"
A rollover study to provide continued treatment with GSK2118436 to subjects with BRAF mutation-positive tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- melanoma, gastric, colorectal, breast, lung, prostate, pancreas, biliary, head and neck, kidney, bladder, sarcoma, brain

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any, following prior participation on GSK BRF study

Investigational Agent

Dabrafenib

Drug Class

BRAF inhibitor

PI

Jason Chandler, MD

Sponsor

GlaxoSmithKline

Path

BRAF mutation

Key Eligibility Criteria Details
Currently participating in a trial of dabrafenib
No evidence of progressive disease on dabrafenib
No permanentdiscontinuation of dabrafenib for toxicity
No unresolved toxicity of grade 2 or higher
LVEF >50% at transition to this study
QTc <480 ms
No CHF
BREAST: Metastatic; Post-menopausal; ER+; AR+; "G200802"
A phase 2 open label, multi-center, multinational, randomized, parallel design study investigating the efficacy and safety of GTx-024 on metastatic or locally advanced ER+/AR+ breast cancer (BC) in postmenopausal women VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Hormone Receptor Positive Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>1 prior line of endocrine therapy<1 line of chemotherapy (not including targeted tx)

Investigational Agent

GTx-024

Drug Class

Selective Androgen Receptor Modulator (SARM)

PI

Lee Schwartzberg, MD

Sponsor

GTx

Path

AR+ (Androgen Receptor Positive)ER+ (Estrogen Receptor Positive)

Key Eligibility Criteria Details

Metastatic or recurrent locally advanced BC with disease progression
Post-menopausal
ER positive, AR (Androgen Receptor) positive
HER2- (negative)
At least 1 prior hormonal treatment in metastatic or adjuvant setting
- If receipt in metastatic setting, DoR must have been at least 6 months
-�If receipt in adjuvant setting, DoR must be at least 3 years
No more than 1 course of chemo (not including immuno or targeted therapies) for metastatic disease
No uncontrolled CNS mets (must be stable for 28 days prior to enrollment)
Measurable disease with evidence of progression
ECOG PS 0-1
No HBV or HCV
No hormone replacement therapy

BREAST: Metastatic; Triple negative; AR+; \"G200901\"

A phase 2 open label, multi-center, multinational study investigating the efficacy and safety of GTx-024 on advanced androgen receptor-positive triple negative breast cancer (AR+ TNBC)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line3rd line

Investigational Agent

GTx-024 (Enobosarm)

Drug Class

Selective androgen receptor modulator

PI

Greg Vidal, MD, PhD

Sponsor

GTx

Path

Breast AdenocarcinomaER/PR negative (-)HER2 negative (-)Androgen Receptor positive (AR+)

Key Eligibility Criteria Details


FemaleTNBC who have received no more than two prior chemotherapy regimens for TNBC
Confirmation of Androgen Receptor Positive (AR>_10% staining by IHC)
ECOG PS 0-1
No symptomatic or untreated CNS mets
No XRT within 14 days of starting therapy
No other malignancy within last 2 years
No HBV, HCV, HIV

SUPPORTIVE CARE: CINV: HEC: 1st Line: "NEPA-15-18"
A phase 3 multicenter, randomized, double-blind, active control study to evaluate the safety and efficacy of IV pro-netupitant/palonosetron (260mg/0.25mg) combination for the prevention of chemotherapy-induced nausea and vomiting in repeated chemotherapy cycles in patients receiving highly emetogenic chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

x- HEC for breast cancer, head and neck cancer, hematologic malignancies, leukemia, lymphoma, lung cancer, bladder cancer

Stage

N/A

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st Line (Prior targeted or endocrine therapy allowed)

Investigational Agent

IV Pro-Netupitant/Palonosetron Fixed Dose Combination

Drug Class

Fixed dose combination NK1 antagonist + 5-HT3 antagonist

PI

Lee Schwartzberg, MD

Sponsor

Helsinn Healthcare SA

Path

Any

Key Eligibility Criteria Details
  • Naïve to cytotoxic chemotherapy (endocrine or targeted therapy allowed)
  • Scheduled to receive at least 4 repeated consecutive cycles with one of the following reference HEC (alone or in combination with other chemo agents) on Day 1
    • Cisplatin as single IV dose >70mg/m2
    • Cyclophosphamide >1500mg/m2
    • Carmustine (BCNU) >250 mg/m2
    • Dacarbazine (DTIC)
    • Mechloretamine (nitrogen mustard)
  • ECOG PS 0-2
  • Adequate laboratory values
  • Cannot be scheduled to receive MEC or HEC on Day 2-5 of a cycle
  • No active nausea of vomiting in 24 hours prior to chemo
  • No symptomatic CNS disease
  • No systemic steroids within 3 days of HEC
  • No anti-emetic medicine within 24 hours of HEC
BREAST: EARLY STAGE: SUPPORTIVE CARE: RECEIVING AC: NEPA 17-05

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Breast Cancer, TNBC, ER+ breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

AC

Investigational Agent

fosnetupitant/palnosetron (IV) or netupitant/palonosetron (oral)

Drug Class

NK1 receptor antagonist, anti-emetic

PI

Lee Schwartzberg, MD

Sponsor

Helsinn Healthcare SA

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed breast cancer, including recurrent or metastatic
  • Naive to moderately or highly emetogenic antineoplastic agents
  • Scheduled to receive at least 4 consecutive cycles of an AC combination regimen
  • ECOG PS 0-1
  • Not scheduled to receive other moderately or highly emetogenic agent (other than AC) from 6 hours after starting AC until next cycle
  • No CNS involvement
  • No concurrent investigational agent/study
SUPPORTIVE CARE: CINV; HEC; "C2013-01"
A Phase 3 Clinical Study Protocol: A prospective, randomized, placebo-controlled, double-blind, multicenter, phase 3 study of APF530 500mg SC, fosaprepitant 150mg IV, and dexamethasone vs. ondansetron 0.15 mk/kg IV, fosaprepitant 150 mg IV, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

x- breast, head and neck (oropharynx, larynx, hypopharynx,oral cavity), lung, sarcoma

Stage

N/A

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

APF530 (Granisetron)

Drug Class

Serotonin 5-HT3 receptor antagonist

PI

Lee Schwartzberg, MD

Sponsor

Heron Therapeutics

Path

Any

Key Eligibility Criteria Details
18-75 years old
Malignant disease

Plan to get HEC (highly emetogenic chemotherapy) including any of following:
AC
Cisplatin (>50mg/m2)
ECOG PS 0-1
Adequate BM, kidney, liver fxn
No EKG interval abnormalities, or clin sig cardiac dz
No multi-day chemotherapy
No benzos within 1 day prior to therapy
No 5-HT3 antagonists within 7 days
No CNS disease

BREAST: Adjuvant; HER2+; "BO28407"
A Study of Kadcyla (trastuzumab emtansine) plus Perjeta (pertuzumab) following anthracyclines in comparison with Herceptin (trastuzumab) plus Perjeta and a taxane following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer. VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Early Breast Cancer

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

TDM1 (Kadcyla), pertuzumab (Perjeta)

Drug Class

anti-HER2 antibody, antibody drug conjugate

PI

Lee Schwartzberg, MD

Sponsor

Hoffman-La Roche

Path

HER2 positive

Key Eligibility Criteria Details

HER2+_ (by IHC or FISH)

Stage II or III (non-metastatic)
If no nodal disease, must be ER/PR negative
>9 weeks sincedefinitive breast surgery
Negative HBV and HCV serology
LVEF>_55%
No prior tx with anti-HER2 therapy, taxanes, or anthracyclines
No known active liver disease
No significant CV disease

BREAST: METASTATIC: TNBC: AKT/PIK3CA/PTEN: 1st Line: \\\"IPATunity130\\\"

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (HR+ ARM CLOSED)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, MBC

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st line chemo

Investigational Agent

Ipatasertib

Drug Class

PI3 kinase inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

Triple negative breast cancer

Key Eligibility Criteria Details
  • Triple negative cancer of the breast, locally advanced or metastatic not amenable to curative resection
  • ECOG PS 0-1
  • Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status by NGS
    • AKT1 missense mutations at E17, L52, or Q79
    • PIK3CA missense mutations at R88, G106, K111, G118, N345, C420, E453, E542, E545, Q546, M1043, H1047, or G1049
    • PTEN homozygous deletion, dominant negative short variant (C124S, G129E, or R130X), less of heterozygosity with copy number 1, double hit 
  • No known brain mets
  • No prior cancers within 5 years
  • No known HIV
  • No cirrhosis
  • No active steroid use (> or = 10mg prednisone/daily)
  • No clinically significant cardiac dysfunction including EF<50%
  • No insulin dependent diabetes
  • No Grade >=2 uncontrolled or untreated hyperlipidemia/hypertriglyceridemia
BREAST: METASTATIC: TRIPLE-NEGATIVE: 1st line: “IMpassion130”

A Phase III, multicenter, randomized placebo-controlled study of atezolizumab (anti-PD-L1 antibody) in combination with nab paclitaxel compared with placebo with nab paclitaxel for patients with previously untreated metastatic triple negative breast cancer.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st Line

Investigational Agent

Atezolizumab

Drug Class

anti-PD-L1 antibody

PI

Greg Vidal, MD, PhD

Sponsor

Hoffmann-La Roche

Path

ER negative (-), PR negative (-), HER2 negative (-)

Key Eligibility Criteria Details
  • Metastatic or locally advanced, histologically documented TNBC
  • No prior chemotherapy or targeted systemic therapy for metastatic TNBC (prior endocrine tx with AR therapy is allowed)
  • Measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No known CNS disease, except for treated asymptomatic CNS mets
  • No history of infratentorial CNS mets, regardless of symptoms or treatment
  • No symptomatic hypercalcemia
  • Not currently receiving denosumab (bisphosphonate tx to prevent skeletal events is OK)
  • No history of autoimmune disease
  • No history of pneumonitis (history of radiation pneumonitis is allowed)
  • HIV negative
  • No receipt of systemic steroids (unless low dose and chronic) within 2 weeks of randomization
BREAST: Primary Treatment; T<1.5cm; Age>65; ER/PR+ HER2-: \"Ice3\"

Cryoablation of low risk breast cancer less than 1.5 cm: An evaluation of local recurrence (Ice-3 trial)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast cancer, early

Stage

Stage 1

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

Ice-Sense3TM

Drug Class

Cryoablative device

PI

Richard Fine, MD, FACS

Sponsor

IceCure Medical

Path

Invasive ductal carcinomaER positivePR positiveHER2 negativeKi-67 <14%

Key Eligibility Criteria Details

 

  • Age >65
  • Tumor size <1.5cm in greatest dimension
  • Unifocal Primary DiseaseInvasive Ductal Carcinoma
  • ER+, PR+ HER2-
  • Ki-67<14%
  • Nottingham Grade 1-2
  • No microinvasion or extensive intraductal component
  • No multi-focal calcifications
  • No prior or concurrent neoadjuvant therapy
  • No en bloc open biopsy or lumpectomy on tissue specimen
BREAST: Metastatic: Triple-Negative: >2nd Line: ASCENT

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Triple negative, TNBC

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

3rd Line or later

Investigational Agent

Sacitzumab govitecan

Drug Class

Antibody-drug conjugate (ADC) of TROP-2 antibody

PI

Lee Schwartzberg

Sponsor

Immunomedics, Inc

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. TNBC determination as per local institution as per standard guidelines.
  • Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC. Prior use of cisplatin (or carboplatin) is permitted.
  • Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.
  • Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
  • ECOG performance score of 0 or 1 .
  • Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
  • Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
  • No Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
  • No Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  • No patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
BREAST: Metastatic; ER/PR+; HER2-; >=3rd line; AR+; "MDV3100-08"
A phase 1 open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetsic of MDV3100 in patients with incurable breast cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

3rd or higher systemic therapy (Endocrine therapy counts as systemic therapy)

Investigational Agent

Enzalutamide

Drug Class

AR antagonist

PI

Lee Schwartzberg, MD

Sponsor

Medivation Inc./ Astellas Pharmaceuticals

Path

AR positive (+) ER/PR positive (+) HER2 negative (-)

Key Eligibility Criteria Details
AR positive breast cancer(10% or greater staining)
ER/PR positive
HER2 negative
Currently receiving fulvestrant (have receivedat least 3 doses)
At least 2 lines of prior therapy
ECOG PS 0-1
No CNS involvement


BREAST: Metastatic; ER/PR+; HER2-; 1st-2nd line: "MDV3100-12"
A phase 2, randomized, double-blind, placebo-controlled, multicenter study of efficacy and safety of enzalutamide in combination with exemestane in patients with advanced breast cancer that is estrogen or progesterone receptor-postiive and HER2-normal VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

1st or 2nd

Investigational Agent

Enzalutamide

Drug Class

Androgen receptor antagonist

PI

Lee Schwartzberg, MD

Sponsor

Medivation Inc, Astellas Pharmaceuticals

Path

ER/PR positive (+)HER2 negative (-)

Key Eligibility Criteria Details
Up to one prior hormone therapy allowed
Up to one prior chemotherapy allowed
ER/PR+
HER2-
Available pathological specimen
No prior exemestane
BREAST: Metastatic: TNBC: 2nd or 3rd line: "KEYNOTE 119"
A randomized open-label phase III study of single agent pembrolizumab versus single agent chemotherapy per physician’s choice for metastatic triple negative breast cancer (mTNBC) – (KEYNOTE-119) VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic triple negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

2nd or 3rd line

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.

Path

ER negative (ER -), PR negative (PR -), HER2 negative (HER2 -)

Key Eligibility Criteria Details
  • Confirmed TNBC (must be confirmed through central testing)
  • Newly obtained tumor biopsy from metastatic site
  • 2nd or 3rd line metastatic
  • Documented disease progression on most recent therapy
  • Must have been previously treated with an anthracycline or a taxane in some setting (neoadj, adj, or met)
  • ECOG PS 0-1
  • No active autoimmune disease that required systemic tx within last 2 years
  • No known CNS disease
  • No other cancer diagnosis within 5 years
BREAST: NEOADJUVANT: TRIPLE NEGATIVE: \\\\\\\"KEYNOTE 522\\\\\\\"

A phase III, randomized, double-blind study to evaluate pembrolizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy for triple negative breast cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Previously untreated locally advanced non-metastatic TNBC definedn as one of the following TNM classifications:
    • T1c, N1-N2
    • T2, N0-N2
    • T3, N0-N2
    • T4a-d, N0-N2
  • ECOG Performance Status 0-1
  • No history of other malignancy within 5 years except cervical CIS, or non-melanoma skin cancer
  • No prior therapy with anti-PD-1
  • No active autoimmune disease that required systemic treatment in past 2 years
BREAST: METASTATIC: Stable brain mets; prior taxane, anthracycline, capecitabine: “ATTAIN”

A Phase 3 open-label, randomized, multicenter study of NKTR-102 versus treatment of physician’s choice (TPC) in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine (ATTAIN)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer, stable brain metastases, MBC

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

2nd line or greater

Investigational Agent

NEKTR 102 (etirinotecan pegol)

Drug Class

pegylated pro-drug

PI

Lee Schwartzberg, MD

Sponsor

Nektar Therapeutics

Path

Adenocarcinoma (any ER/PR/HER2 status)

Key Eligibility Criteria Details
  • Any gender

  • Single-agent cytotoxic chemotherapy indicated

  • Can be measurable or non-measurable disease

  • Must have a history of brain metastases that are non-progressing

  • In TNBC, must have at least 1 prior lines of metastatic cytotoxic therapy

  • In non-TNBC, prior therapy as indicated is required

  • Have received prior therapy with anthracycline, taxane, and capecitabine in any setting (neo-adj, adj, or metastatic)

  • Most recent anti-cancer therapy within 6 months of randomization

  • ECOG PS 0-1

  • No prior SCT

  • No prior camptothecin-derived agent

  • No leptomeningeal disease

  • No HBV/HCV/HIV

  • No cirrhosis

  • No other malignancy within 5 years

  • No need for O2 supplementation

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; FGFR mutation; "SIGNATURE CBGJ398XUS04"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6- BGJ398 for patients with tumors with FGFR genetic abnormalities VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- breast, lung, melanoma, prostate, colorectal, head and neck, gastric, renal, leukemia, lymphoma, sarcoma, ovarian

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/= 2nd line

Investigational Agent

BGJ398

Drug Class

FGFR inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

FGFR genetic alteration

Key Eligibility Criteria Details

Must have FGFR gene alteration as measured in CLIA-certified lab
None of the following malignancies:
Bladder cancer (urothelial)
Cholangiocarcinoma
Endometrial cancer
Glioblastoma multiforme (GBM)
Received at least 1 prior line of therapy
No standard therapy expected to result in durable remission
ECOG PS 0-1
No CNS disease
No acute/chronic pancreatitis
No impared cardiac function
No corneal or retinal disorder
No other cancer within 3 years
_

BREAST: Metastatic: ER/PR+; HER2-; post-mTORi: "BELLE-3"
A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment_ VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Hormone Receptor Positive Breast Cancer

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st line chemo (after failure of mTOR inhibitor)2nd line chemo�(after failure of mTORi AND one line of chemo)

Investigational Agent

BKM120

Drug Class

Pan-class 1 PI3K inhibitor

PI

Jason Chandler, MD

Sponsor

Novartis Pharmaceuticals

Path

ER/PR positive (+)HER2 negative (-)

Key Eligibility Criteria Details

Postmenopausal women
Locally advanced or metastatic breast cancer
HER2-, ER/PR+
Most recent progression must be on combination mTORi and AI
No more than one prior metastatic chemo regimen
No chronic steroid treatment
No active cardiac disease

MOLECULARLY TARGETED: Metastatic: >/=2nd line; P2P: "SIGNATURE CBKM120ZUS40"
Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 1 - BKM120 for patients with PI3K-activated tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced Cancer; Head and Neck (SCCHN), Non-Hodgkin Lymphoma (NHL), Ovarian, Bladder (Urothelial), Cervical, Liposarcoma, Adenoid Cystic

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

BKM120

Drug Class

PI3K inihibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

PI3K activation (PI3K mutation, PTEN mutation, loss of PTEN, PI3K amplification, or loss-of-function mutation of PI3KR1)

Key Eligibility Criteria Details
One (or more) of following abnormalities:
PI3K mutation, deletion, or amplification
PTEN mutation
Loss of function of PI3KR1
None of the following malignancies:
CRC, NSCLC, breast, prostate, endometrial, GMB
At least one prior line of therapy
No standard options anticipated to provide benefit
ECOG 0-1
No CNS mets
No significant mood disorder

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; ALK/ROS1+; "SIGNATURE CLDK378AUS23"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module-7; ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1 VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- breast, colon, prostate, colorectal, sarcoma, melanoma, bladder, renal, head and neck, leukemia, lymphoma, gastric, esophageal, ROS1 positive lung

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/= 2nd line

Investigational Agent

Ceritinib

Drug Class

ALK inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

ALK or ROS1 mutation, translocation, rearrangement, or amplification

Key Eligibility Criteria Details

ALK or ROS1 mutation, trnaslocation, rearrangement, or amplification by CLIA-certified laboratory (IHC or FISH allowed)

May not have ALK+ lung cancer (butROS1 positive lung CA allowed)
Relapsed or progressive disease
ECOG PS 0-1
2nd line or higher
No standard therapy withdurable remission expected
No CNS disease

BREAST; Neoadjuvant; ER/PR+; "MONALEESA-1"
A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer__ VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer

Stage

Stage 1

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

LEE011

Drug Class

CDK 4/6 Inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis

Path

ER+ or PR+ (positive) HER2 - (negative)Grade 2 or 3 invasive disease

Key Eligibility Criteria Details
Resectable breast cancer
Postmenopausal
ER and/or PR positive (+)
Grade 2 (II) or 3 (III) invasive cancer
HER2 - (negative)
One lesion at least 1.0 cm by imaging
ECOG 0 or 1
No prior therapy
No active cardiac history, QT prolongation
No strong concurrent CYP3A4 inducers/inhibitors


Breast: Adjuvant (following chemo): ER positive: HER2 negative: \\\"EarLEE-1\\\"

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

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Malignancy

Breast Cancer, Hormone Receptor Positive Breast Cancer

Stage

Stage 3

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Following (neo)adjuvant chemo

Investigational Agent

ribociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

ER/PR +, HER2-

Key Eligibility Criteria Details
  • Histologically confirmed unilateral primary invasive adenocarcinoma of the breast
  • Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer
  • Patient is after surgical resection of the tumor where tumor was removed completely,
  • Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue
  • Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ≥ 4 cycles or ≥ 12 weeks which included taxanes prior to screening
  • Patient has completed adjuvant radiotherapy (if indicated) prior to screening
  • Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
  • ECOG PS 0-1
  • No prior treatment with CDK4/6 inhibitor
  • No prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
  • No prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin
  • No distant metastases of breast cancer beyond regional lymph nodes
  • Uncontrolled hypertension with systolic blood pressure >160 mmHg
MOLECULARLY TARGETED: Metastatic; >/= 2nd line; CDK4/6 pathway activation: "SIGNATURE CLEE011XUS03"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8- LEE011 for patients with CDK4/6 pathway activated tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Colorectal, Ovarian, Gastric, Kidney, Leukemia, Lymphoma, Head and Neck, Breast Cancer, Esophagus, Liver, Bladder

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

No further standard therapies

Investigational Agent

LEE011

Drug Class

CDK4/6 Inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

CDK4/6, cyclin D1/3, or p16 aberrations

Key Eligibility Criteria Details

Any of the following molecular alterations
CDK4 amplification or mutation
CDK6 amplification or mutation
Cyclin D1 (CCND1) amplification
Cyclin D2 (CCND3) amplifcation
p16 (CDKN2A) mutationNone of the following malignancies:
ER/PR or HER2 positive breast cancer (TNBC only allowed)
Sarcoma (Eligible but cohort on hold)
Lung Cancer (Eligible but cohort on hold)
liposarcoma
prostate cancer
melanoma
teratoma
mantle cell lymphoma_
ECOG PS 0-1
No CNS involvement
At least one prior metastatic therapy
No expectation that further therapy will result in durable remission
MOLECULARLY TARGETED: Metastatic; >/=2nd line; P2P; "SIGNATURE CTKI258AUS26"
Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 2 - Dovitinib for patients with tumor pathway activations inhibited by dovitinib including tumors with mutations or translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk, and RET VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced Cancer; non-squamous NSCLC (non-small cell lung), Melanoma, Ovarian, Thyroid, Multiple Myeloma, GIST (gastrointestinal stromal tumor), AML (acute myeloid leukemia)

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

Dovitinib (TKI258)

Drug Class

Angiogenesis inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

Mutations or transolocations in: FGFR PDGFR VEGF cKIT FLT3 CSFR1 Trk RET

Key Eligibility Criteria Details
Mutation or translocation of at least one of following genes:


FGFR 1/2/3, FLT3, cKIT,VEGFR 1/2, RET,
TrkA (NTRK1),PDGFRa/b,CSF-1R_
None of the following tumors:
Breast
RCC (kidney/renal)
Bladder
HCC (hepatocellular)
Endometrial
Squamous NSCLC
Heme malignancies (exceptFLT3 AML and MM)
At least one prior therapy for disease
ECOG 0-1
No brain mets
No anticoagulation
BREAST: Metastatic: HR Positive: HER2 Negative: 1st or 2nd line: \"CONTESSA\"

Randomized, Phase 3 Study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2 Negative, HR Positive, Locally advanced or metastatic breast cancer previously treated with a taxane

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Malignancy

Breast, Breast Cancer

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st or 2nd Line Chemotherapy after receipt of adjuvant/neoadjuvant taxane. Any number of prior endocrine tx allowed.

Investigational Agent

Tesetaxel

Drug Class

Orally administered taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics

Path

Hormone Receptor Positive, ER Positive, PR positive, HER2 Negative, HER2-

Key Eligibility Criteria Details
  • HER2 negative disease
  • HR (ER and/or PgR) psoitive disease
  • Measurable disease
  • ECOG PS 0-2
  • Must have received prior taxane containing regimen in the neoadjuvant or adjuvant setting
  • If indicated, must have received prior anthracycline containing regimen in neoadjuvant, adjuvant, or metastatic setting
  • Unless not indicated (e.g. rapidly progressing disease), must have received prior endocrine therapy. No limit on number of prior endocrine therapies or targeted therapies (CDK4/6, everolimus)
  • Documented disease recurrence or progression
  • Ability to swallow pills
  • No more than 1 prior chemotherapy regimen for advanced disease (not including targeted therapy)
  • No prior use of a taxane in the metastatic setting
  • No known CNS involvement
  • No other cancer within 5 years
  • No known HIV/HBV/HCV
  • No neuropathy > Grade 1
BREAST: Metastatic; ER/PR+, HER2-; Any line; "A5481034 EAP"
An expanded access study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor positive, HER2 negative advanced breast cancer for whom letrozole therapy is deemed appropriate. VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast: Metastatic Breast

Stage

Stage 4

Phase

Phase 4

Status

Closed to Accrual

Line Of Therapy

Any

Investigational Agent

Palbociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Pfizer

Path

ER or PR positive HER2 negative

Key Eligibility Criteria Details
Post menopausal woman (defined by local guidelines or clinical practice)
ER+ or PR+ (local lab OK)
HER2 negative(local lab OK)
Appropriate candidates for letrozole
ECOG PS 0-2
ANC>1.5, plt>100, Hgb>9
ALT/AST <5x ULN
Tbili <3x ULN
Cr <1.5 ULN or GFR >60
No prior tx with CDK4/6 inhibitor
No high cardiovascular risk (recent MI, long QT, arrythmias)
No other malignancy within 3 years
No uncontrolled brain mets
ADVANCED SOLID TUMORS: Phase 1; TNBC/HER2+BC/NSCLC: "PCYC-1135-CA"
A multicenter study of the Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, in combination with MEDI4736, in subjects with relapsed or refractory solid tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- Advanced Solid Tumors; Breast Cancer (HER2+ only) or lung cancer (squamous cell NCLC only)

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

>2nd line for NSCLC, >3rd line for breast

Investigational Agent

Ibrutinib and MEDI4736

Drug Class

Bruton's Tyrosine Kinase (BTK) Inihibitor (Ibrutinib), PD-L1 inhibitor (MEDI4736)

PI

Jason Chandler, MD

Sponsor

Pharmacyclics

Path

TNBC or HER2+�breast cancerAdenocarcinoa or squamous carcinoma of lung

Key Eligibility Criteria Details

Either NSCLC (squamous only), Breast Cancer (HER2+ only)
Relapsed/refractory disease
One or more measurable disease lesions
ECOG PS 0-1Coags within 1.5x ULN
Creatinine within 2x ULN
No CNS involvement
No prior tx with BTK inhibitors (eg.ibrutinib), or immune tx (CTLA-4, PD-1, PD-L1).
No systemic steroids >10mg daily prednisone within last 14 days except as given as premed
No current or prior autoimmune disorders within 3 years
No other malignancies within 5 years
No known HBV/HCV/HIV

BREAST: Metastatic: HER2+; >or=3rd line; "NALA"

A study of neratinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2+ metastatic breast cancer who have received two or more prior HER2-directed regimens in the metastatic setting (NALA).

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Malignancy

Breast, Metastatic HER2 positive Breast Cancer

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

>2nd line

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Greg Vidal, MD, PhD

Sponsor

Puma Biotechnology

Path

HER2+

Key Eligibility Criteria Details

Metastatic breast cancer

HER2 overexpression or gene amplified tumor (IHC3+ or IHC2+ with positive FISH)

Prior treatment with at least 2 HER2-directed regimens for metastatic breast cancer

Measurable disease per RECIST 1.1

ECOG PS 0-1

No prior therapy with capecitabine, neratinib, lapatinib, or other HER2 directed TKI.

No active (symptomatic CNS mets)

No significant chronic GI disorder with diarrhea as a major symptom

BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: EMERALD

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

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Malignancy

Breast, invasive breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

2nd Line (post CDK4/6 inh)

Investigational Agent

Elacestrant

Drug Class

Selective Estrogen Receptor Degrader (SERD)

PI

Greg Vidal, MD, PhD

Sponsor

Radius Pharmaceuticals, Inc.

Path

adenocarcinoma, ER/PR +, HER2-

Key Eligibility Criteria Details
  • Subjects with adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or XRT, or metastatic disease
  • Must be appropriate candidates for endocrine monotherapy
  • Either measurable disease or bone-only (nonmeasurable) disease
  • Post-menopausal women or men
  • Must be ER+, HER2 -
  • Must have received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer
  • Must have received prior treatment with CDK4/6 inhibitor in combination with either fulvestrant or an AI
  • No more than one line of chemotherapy in the advanced/metastic setting
  • No prior treatment with investigational SERD or ER antagonist
  • No presence of symptomatic visceral disease
BREAST: Early: Supportive Care: Growth Factor: Receiving TC chemo: "ADVANCE"

Randomized trial of SPI-2012 versus pegfilgrastim in the management of chemotherapy induced neutropenia in breast cancer patients receiving docetaxel and cyclophosphamide

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Malignancy

x- Breast Cancer, Early Breast Cancer, IDC, ILC

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

SPI-2012

Drug Class

Long-acting myeloid growth factor

PI

Lee Schwartzberg, MD

Sponsor

Spectrum Pharmaceuticals, Inc

Path

Any

Key Eligibility Criteria Details
  • New diagnosis of early-stage breast cancer (Stage I to Stage IIIA)
  • Candidate for/plan to receive adjuvant or neoadjuvant TC chemo (docetaxel/cyclophosphamide)
  • ECOG PS 0-2
  • No locally recurrent, metastatic, or contralateral breast CA
  • No other concurrent adjuvant therapy
  • No prior exposure to myeloid growth factors
  • No surgery or radiation within 30 days of enrollment
  • No active concurrent malignancy
  • Labs wnl as per protocol
OVARIAN: METASTATIC: Platinum Resistant: PHASE 1: 2nd to 5th line: “KEYNOTE-162 Ovarian”

Phase 1/2 clinical study of niraparib in combination with pembrolizumab in patients with advanced or metastatic triple-negative breast cancer and in patients with recurrent ovarian cancer

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Malignancy

Ovarian cancer, fallopian tube cancer, primary peritoneal cancer

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line to 5th line

Investigational Agent

Niraparib, Pembrolizumab

Drug Class

PARP inhibitor, PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Tesaro, Inc

Path

High-grade serous

Key Eligibility Criteria Details
  • High-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have recurrent disease and have been previously treated with chemotherapy for advanced/metastatic disease and who experience a response lasting at least 6 months to first-line platinum based-therapy but currently considered platinum-resistant
  • Up to 4 lines of prior therapy allowed in Phase 1 portion, Up to 3 lines allowed in Phase 2 portion
  • May not have progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line
  • Measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No active CNS mets (stable for at least 4 weeks and resolution of symptoms are allowed)
  • No additional malignancy within 5 years (except non-melanoma skin, in situ of  cervix)
  • No chronic systemic steroid use
  • No active autoimmune disease that has required treatment in last 2 years
  • No history of interstitial lung disease
  • No history of platelet transfusion for chemo-induced thrombocytopenia
  • No prior anti-PD1 or PARP therapy
BREAST: METASTATIC: TNBC: PHASE 1: 2nd to 4th line:: “KEYNOTE-162 TNBC

Phase 1/2 clinical study of niraparib in combination with pembrolizumab in patients with advanced or metastatic triple-negative breast cancer and in patients with recurrent ovarian cancer

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Malignancy

Breast, Metastatic triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line to 4th line

Investigational Agent

Niraparib, Pembrolizumab

Drug Class

PARP inhibitor, PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Tesaro, Inc

Path

ER- (negative), PR- (negative), HER2- (negative) adenocarcinoma

Key Eligibility Criteria Details
  • TNBC who have been treated with at least 1 prior regimen for advanced/metastatic disease or who relapsed/progressed while on or within 1 month from completion of adjuvant chemotherapy
  • Up to 3 lines of prior therapy allowed in Phase 1 portion, Up to 2 lines allowed in Phase 2 portion
  • May not have progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line
  • Measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No active CNS mets (stable for at least 4 weeks and resolution of symptoms are allowed)
  • No additional malignancy within 5 years (except non-melanoma skin, in situ of  cervix)
  • No chronic systemic steroid use
  • No active autoimmune disease that has required treatment in last 2 years
  • No history of interstitial lung disease
  • No history of platelet transfusion for chemo-induced thrombocytopenia
  • No prior anti-PD1 or PARP therapy
BREAST: METASTATIC: ER+: Post-menopausal: DOD 16-1001

Phase II trial of fulvestrant plus enzalutamide in ER+/HER2- advanced breast cancer

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Malignancy

Breast Cancer, Metastatic Breast Cancer, MBC

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

Any (pre-fulvestrant)

Investigational Agent

Enzalutamide

Drug Class

Androgen receptor inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

University of Colorado, Department of Defense

Path

ER+, HER2-

Key Eligibility Criteria Details
  • ER+, HEr2- metastatic breast cacner
  • Candidate for fulvestrant therapy- patients who ahve started fulvestrant may enter if within 3 months of starting fulvestrant
  • ECOG PS 0-2
  • Willing to provide fresh tissue biopsies
  • Post-menopausal. If pre-menopausal will need to receive concurrent ovarian suppression
  • No CNS disease
  • No history of seizures
  • No prior treatment with anti-androgen agent
BREAST: Metastatic; BRCA mutant; "M12-895"
A randomized, phase 2 study of the efficacy and tolerability of veliparib in combination with temozolomide or veliparib in combination with carboplatin and paclitaxel versus placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and metastatic breast cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

1st line2nd line3rd line

Investigational Agent

Veliparib

Drug Class

PARP inhibitor

PI

Lee Schwartzberg, MD

Sponsor

AbbVie (Abbott)

Path

BRCA germline mutation

Key Eligibility Criteria Details

Unresectable recurrent or metastatic disease
BRCA1 or BRCA2 germline mutation
ECOG 0-2
If HER2 positive, must have either progressed on HER2 tx or ineligible to receive HER2 tx
No more than 2 prior lines of cytotoxicchemotherapy
No prior taxane therapy in metastatic setting
No brain mets or history of brain mets
Not pregnant or breastfeeding_

ADVANCED SOLID TUMORS: Phase 1; TNBC and ovarian; aurora-kinase; "20080016"
A Phase 1, first-in-human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered AMG 900 in adult subjects with advanced solid tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- Advanced Solid tumors, Breast cancer, TNBC, ovarian

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line or later

Investigational Agent

AMG 900

Drug Class

Aurora kinase inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Amgen

Path

TNBC or ovarian CA

Key Eligibility Criteria Details

Triple negative breast cancer or ovarian cancerTaxane-resistant (refractory to or progression within 6 moths)
Platinum resistant (ovarian cancer only)

ECOG<2
No active brain mets
No history of hematologic malignancy
No recent steroids
No systemic anticoagulation within 28 days

BREAST: Metastatic: HER2 negative: 1st-3rd line: "D081EC00001"
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety, Tolerability and Efficacy of Olaparib in Combination With Carboplatin: Part A: Dose Escalation of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer; Followed by Part B: an Expansion Phase of Olaparib in Combination With Carboplatin in the Neoadjuvant Treatment of HER-2 Negative Breast Cancer Patients With Germline BRCA1/2 Mutations VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic HER2 negative breast cancer,

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

1st, 2nd, or 3rd

Investigational Agent

olaparib

Drug Class

PARP inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

HER2 neg. HR+ or HR-

Key Eligibility Criteria Details
  • Advanced or metasatic HER2- breast cancer
  • Between 0-2 lines of prior chemotherapy
  • Neoadj or adjuvant therapy counts as a line of therapy if given within 12 months of development of metastatic disease
  • CNS disease allowed if >12 weeks after treatment and patient is off steroids
  • No prior platinum in metastatic setting
  • No known HBV, HCV, or HIV
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