Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 400
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 modific...
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
Tracking Information
- NCT #
- NCT03901339
- Collaborators
- Not Provided
- Investigators
- Study Director: Immunomedics Medical Director Gilead Sciences