OncRef

Clinical Trial: NCT00829166

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2016-10-31

Study Overview

Brief 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.

Official Title

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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Trastuzumab emtansine
  • Drug: Lapatinib
  • Drug: Capecitabine

Other Study ID Numbers

  • BO21977
  • TDM4370g

Start Date

2009-02

Primary Completion Date (Actual)

2012-07

Study Completion Date (Actual)

2015-09

Enrollment (Actual)

991

Study Type

Interventional

Phase

Phase 3