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 Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
In Brief
A Phase 3 clinical trial evaluating Trastuzumab deruxtecan (DS-8201a), Capecitabine, and 4 other interventions for Breast Cancer. Active but no longer recruiting, targeting 557 participants across 208 sites in 20 countries.
Detailed Summary
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body
Study Details
Timeline
Interventions
DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Administered according to label, as one option for Physician's Choice (determined before randomization)
Administered according to label, as one option for Physician's Choice (determined before randomization)
Administered according to label, as one option for Physician's Choice (determined before randomization)
Administered according to label, as one option for Physician's Choice (determined before randomization)
Administered according to label, as one option for Physician's Choice (determined before randomization)