At a glance
ClinicalIndex Comparison RecordPhase 3Active· 524 enrolled
Drug / intervention
Trastuzumab deruxtecan (T-DXd) +1 moredrug
Likely dose
Trastuzumab deruxtecan (T-DXd) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
In Brief
A Phase 3 clinical trial evaluating Trastuzumab deruxtecan (T-DXd) and Ado-trastuzumab emtansine (T-DM1) for Breast Cancer. Active but no longer recruiting, targeting 524 participants across 164 sites in 15 countries.
Detailed Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsDaiichi Sankyo Co., Ltd., AstraZeneca
Timeline
Phase 3Active
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartAug 2018
Primary CompletionMay 2021
TodayJul 2026
Study CompletionJul 2026
First PostedMay 18, 2018
Enrollment StartAug 9, 2018
Primary CompletionMay 21, 2021
Study CompletionJul 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.1 years ago
Interventions
Trastuzumab deruxtecan (T-DXd)drug
T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.
Ado-trastuzumab emtansine (T-DM1)drug
The treatment will be in accordance with the approved label.