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

NCT00829166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 991

Last updated 2016-10-31

Study results available
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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.

Conditions

Interventions

DRUG

Trastuzumab emtansine

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

DRUG

Lapatinib

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

DRUG

Capecitabine

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-07-31
Completion
2015-09-30

Countries

  • United States
  • Bosnia 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

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00829166 on ClinicalTrials.gov