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Clinical Research & Trials

USO 21536

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (GS-US-592-6173)


Disease Types: Breast Cancer Research

Eligibility Requirements:

-Locally advanced (inoperable) or metastatic triple negative breast cancer that is PD-L1 positive with measurable disease
-Must have completed treatment for stage I-III as indicated with 6 ≥ months between finishing treatment with curative intent and documented disease recurrence, de novo metastatic triple negative breast cancer allowed
-No: previous treatment for advanced disease; prior therapy with agent directed to another stimulatory or coinhibitory T Cell receptor (CTLA-4, OX-40, CD137);
received systemic anticancer treatment within past 6 months or radiation treatment within last 2 weeks; received topoisomerase 1 inhibitors or antibody drug conjugates
containing isomerase inhibitor; HIV positive patients with history of Kaposi’s sarcoma and/or multicentric Castleman’s disease; active Hep B or Hep C infection; autoimmune disease requiring 
systemic treatment within past 2 years; have known active central nervous system metastasis or carcinomatous meningitis; allogenic tissue or solid organ transplant; myocardial infarction or unstable angina pectoris within last 6 months, history of ventricular arrhythmia or high grade atrioventricular block or other cardiac arrhythmias requiring antiarrhythmic medication, New York Heart Association Grade III or IV heart failure or ejection fraction < 40%, history of QT interval prolongation; have active chronic inflammatory bowel disease (ulcerative colitis or Crohn’s) or GI perforation in last 6 months; history of or active non-infectious pneumonitis or interstitial lung disease, history of active tuberculosis. 

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