West Cancer Center

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)

Title

GTx G200901

Study Title

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)

Site Link

NCT02368691

Malignancy

Breast, Metastatic Triple Negative Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line3rd line

Investigational Agent

GTx-024 (Enobosarm)

Drug Class

Selective androgen receptor modulator

Greg Vidal, MD, PhD

Sponsor

GTx

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02368691

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

Objective

Primary- Clinical benefit rate; Secondary- ORR, BOR, PFS, TTP, DOR, safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

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

Dosing Frequency

GTx-024 18mg PO daily

Control Agents

N/A

Study Protocol

Randomized