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

Titre officiel

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens

Sommaire:

This is an open-label, randomized, multicentre 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.

Description de l'essai

Primary Outcome:

  • Progression-free survival (PFS)
  • Objective (overall) response rate (ORR)
Secondary Outcome:
  • Overall Survival (OS)
  • Duration of Response (DoR)
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

Voir cet essai sur ClinicalTrials.gov

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