Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens
Clinical Trial Information
Trial Contact: Jarquin-Castillo, Katherine ; Jobson, Gillian S
IRB No: 19.226.08
Protocol Abbrev: IMMU-132-09
Principal Investigator: Regan Derek Rostorfer, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: TROPICS-02
Treatment: Investigational Arm: Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle). Control Arm: Eribulin; Capecitabine; Gemcitabine; Vinorelbine
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT03901339
To compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.
• Female or male subjects aged ≥18 years at the time of signing the informed consent form
• Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
• Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC including:
• At least 1 prior anticancer hormonal treatment.
• At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
• Eligible for one of the chemotherapy options listed in the TPC arm
• Documented disease progression after the most recent therapy