Recruitment

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