At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
In Brief
A Phase 3 clinical trial evaluating Trastuzumab deruxtecan, Capecitabine, and 2 other interventions for Breast Cancer. Completed, enrolled 608 participants across 227 sites in 15 countries.
Detailed Summary
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body
Study Details
Timeline
Interventions
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Investigator's choice Standard of Care when combined with capecitabine
Investigator's choice Standard of Care when combined with capecitabine