At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
Trastuzumab emtansinedrug
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 Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Trastuzumab emtansine for Breast Cancer. Completed, enrolled 153 participants across 44 sites in 8 countries.
Detailed Summary
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBelgium, France, Germany, Italy, Russia, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartOct 2010
Primary CompletionJun 2013
TodayJul 2026
First PostedSep 8, 2010
Enrollment StartOct 1, 2010
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.8 years ago
Interventions
Trastuzumab emtansinedrug
Trastuzumab emtansine was provided as a single-use lyophilized formulation in a glass vial.