Last updated on June 2020

Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)


Brief description of study

This is an open-label, randomized, multicenter Phase 3 study 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.

Detailed Study Description

Approximately 400 eligible subjects will be randomized to one of the following 2 treatment

arms

Investigational Arm:

Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).

Control Arm:

Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).

Eribulin; Capecitabine; Gemcitabine; Vinorelbine

Clinical Study Identifier: NCT03901339

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Institut de Canc rologie Lucien Neuwirth

Saint-Priest-en-Jarez, France
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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