This study will compare DS 8201a to standard treatment.
Participants must have HER2 breast cancer that has been treated before.
- cannot be removed by an operation
- has spread to other parts of the body
The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 600 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
Actual Study Start Date: August 1, 2018
Estimated Primary Completion Date: February 2022
Estimated Study Completion Date: February 2022
- Experimental: Trastuzumab deruxtecan (DS-8201a)
- Active Comparator: Trastuzumab+capecitabine
- Active Comparator: Lapatinib+capecitabine
|Date last updated at source||2019-07-16|
|Study start date||2018-08-01|
|Estimated primary completion date||2022-02-01|