At a glance
ClinicalIndex Comparison Record- ✓Metastatic triple-negative breast cancer (TNBC)
- ✓ER-negative (≤10%), PR-negative (≤10%), and HER2-negative by IHC and/or FISH
- ✓Androgen receptor positive (AR≥50% nuclear staining by IHC)
- ✓ECOG performance status 0-1
- ✕Prior anti-PD-1, PD-L1, or PD-L2 agents
- ✕Prior AR-targeted agents (GTX-024, enzalutamide, or other)
- ✕Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 21 days
- ✕Testosterone or testosterone-like agents within 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Clinical Trial of the Combination of Pembrolizumab and Selective Androgen Receptor Modulator (SARM) GTX-024 in Patients With Metastatic Androgen Receptor (AR) Positive Triple Negative Breast Cancer (TNBC)
In Brief
A Phase 2 clinical trial evaluating Enobosarm, Laboratory Biomarker Analysis, and 1 other intervention for Androgen Receptor Positive and 5 related conditions. Completed, enrolled 18 participants across 7 sites.
Detailed Summary
This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than pembrolizumab alone in treating patients with androgen receptor positive triple negative breast cancer.
Study Details
Timeline
Interventions
Given PO
Correlative studies
Given IV