West Cancer Center

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

Title

GTx G200802

Study Title

Site Link

NCT02463032

Malignancy

Breast, Metastatic Hormone Receptor Positive Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

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)

Lee Schwartzberg, MD

Sponsor

GTx

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02463032

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

Objective

Primary- Clinical Benefit Rate at 24 weeks: Secondary- ORR, BoR, PFS, TTP, DoR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

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

Dosing Frequency

GTx-024 9 mg PO daily vs. GTx-024 18 mg PO daily

Control Agents

Study Protocol

Randomized

Yes