At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 437 enrolled
Drug / intervention
(vic-)trastuzumab duocarmazine +1 moredrug
Likely dose
Not stated in 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 Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating (vic-)trastuzumab duocarmazine and Physician's choice for Metastatic Breast Cancer. Completed, enrolled 437 participants across 90 sites in 11 countries.
Detailed Summary
The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesBelgium, Canada, Denmark, France, Italy, Netherlands, Singapore, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartDec 2017
Primary CompletionMar 2021
Study CompletionJun 2022
TodayJul 2026
First PostedAug 25, 2017
Enrollment StartDec 15, 2017
Primary CompletionMar 31, 2021
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.9 years ago
Interventions
(vic-)trastuzumab duocarmazinedrug
Intravenous SYD985, Q3W
Physician's choicedrug
See drug label