Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- MBC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
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 330 eligible subjects will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio: 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 guidel...
Approximately 330 eligible subjects will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio: 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 Subjects will be treated until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Tracking Information
- NCT #
- NCT04639986
- Collaborators
- Iqvia Pty Ltd
- Medidata Solutions
- Parexel
- Investigators
- Study Director: Jack Chen, MD Everest Medicines
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