USO 21537
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician¡¯s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors do Express PD-L1 (GS-US-592-6238)
Disease Types: Breast Cancer Research
Eligibility Requirements:
Locally advanced (inoperable) or metastatic triple negative breast cancer that is PD-L1 negative with measurable disease, patients with PD-L1 positive tumors at screening may be eligible if they received treatment with PD-L1 inhibitor in neoadjuvant or adjuvant setting
-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; received systemic anticancer treatment within past 6 months or radiation treatment within last 2 weeks; received topoisomerase 1 inhibitors or antibody drug conjugatescontaining isomerase inhibitor; HIV positive patients with history of Kaposi’s sarcoma and/or multicentric Castleman’s disease; active Hep B or Hep C infection; 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
Available at:
- Chesapeake
- Newport News (Port Warwick III)
- Virginia Beach (Princess Anne)
- Norfolk (Brock Cancer Center)