CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 991 enrolled
Drug / intervention
Trastuzumab emtansine +2 moredrug
Likely dose
Trastuzumab emtansine 3.6 mg/kgfrom 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/NCT00829166
NCT00829166Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

Hoffmann-La Roche·interventional·Posted Jan 26, 2009·Updated Oct 31, 2016

In Brief

A Phase 3 clinical trial evaluating Trastuzumab emtansine, Lapatinib, and 1 other intervention for Breast Cancer. Completed, enrolled 991 participants across 323 sites in 27 countries.

Detailed Summary

This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Mexico, New Zealand, Philippines, Poland, Portugal, Russia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJul 1, 2012
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.4 years ago

Interventions

Trastuzumab emtansinedrug

Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.

Lapatinibdrug

Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.

Capecitabinedrug

Capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.