CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,185 enrolled
Drug / intervention
Trastuzumab Emtansinedrug
Likely dose
Trastuzumab Emtansine 3.6 milligramsfrom 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.

Search/NCT01702571
NCT01702571Phase 3Completed
CompareCT.gov

A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

Hoffmann-La Roche·interventional·Posted Oct 8, 2012·Updated Apr 4, 2022

In Brief

A Phase 3 clinical trial evaluating Trastuzumab Emtansine for Breast Cancer. Completed, enrolled 2,185 participants across 300 sites in 43 countries.

Detailed Summary

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Italy, Luxembourg, Mexico, Netherlands, Norway, Panama, Peru, Poland, Portugal, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2012
Enrollment StartNov 27, 2012
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 13.7 years ago

Interventions

Trastuzumab Emtansinedrug

Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.