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Study of IMMU-132 in HR+/HER2- MBC

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

    Trial Phone: 321.841.1077 ; 321.841.2285

  • 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

  • Objective

    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.

  • Key Eligibility

    •   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