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Clinical Research & Trials

USO 21234

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm Monotherapy Versus Active Control for the Treatment of AR+/ER+/HER2- Metastatic Breast Cancer in Patients with Androgen Receptor Nuclei Staining greater than or equal to 40% Who Have Shown Previous Disease Progression on a Nonsteroidal Aromatase Inhibitor, Fulvestrant and CDK 4/6 inhibitor (V3002401) ARTEST

 

Disease Types: Breast Cancer Research

Eligibility Requirements:


-ER+/HER 2 (-) metastatic breast cancer with measurable disease, androgen staining of ≥ 40% by central lab testing
-Must have received nonsteroidal AI (monotherapy or combination therapy) either for adjuvant or metastatic breast cancer and fulvestrant for metastatic breast cancer. At least one, non-steroidal AI or fulvestrant, must have
been given in combination with CDK 4/6 inhibitor. 
-Must have previously responded to treatment (without disease progression for 6 months) to either fulvestrant (monotherapy or with CDK 4/6 inhibitor) or non-steroidal AI (monotherapy or with CDK 4/6 inhibitor) for metastatic breast cancer
-No: received more than one systemic treatment for metastatic breast cancer (doesn’t include immunotherapy or targeted therapy)

Available at: