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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00829166

Public ClinicalTrials.gov record NCT00829166. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 26, 2026, 2:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00829166
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
991 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2009 (Type not available)
Primary completion
Jul 2012 (Actual)
Completion
Sep 2015 (Actual)
Last update posted
Oct 31, 2016

2009 – 2015

United States locations

U.S. sites
177
U.S. states
36
U.S. cities
152
Facility City State ZIP Site status
Not listed Chandler Arizona 85224 —
Not listed Tucson Arizona 85719 —
Not listed Anaheim California 92801 —
Not listed Anaheim California 92807 —
Not listed Bakersfield California 93309 —
Not listed Baldwin Park California 91706 —
Not listed Bellflower California 90706 —
Not listed Duarte California 91010 —
Not listed Fontana California 92335 —
Not listed Hayward California 94545 —
Not listed Irvine California 92618 —
Not listed La Jolla California 92093 —
Not listed La Mesa California 91942 —
Not listed Loma Linda California 92354 —
Not listed Long Beach California 90806 —
Not listed Los Angeles California 90025 —
Not listed Los Angeles California 90034 —
Not listed Los Angeles California 90057 —
Not listed Los Angeles California 90095-1772 —
Not listed Montebello California 90640 —
Not listed Newport Beach California 92660 —
Not listed Oakland California 94611 —
Not listed Panorama City California 91402 —
Not listed Riverside California 92505 —
Not listed Roseville California 95661 —
Not listed Sacramento California 95825 —
Not listed San Diego California 92120 —
Not listed San Diego California 92123 —
Not listed San Francisco California 94115 —
Not listed San Jose California 95119 —
Not listed Santa Clara California 95051 —
Not listed Santa Maria California 93454 —
Not listed Santa Monica California 90404 —
Not listed South San Francisco California 94080 —
Not listed Thousand Oaks California 91360 —
Not listed Vallejo California 94589 —
Not listed Walnut Creek California 94596 —
Not listed Woodland Hills California 91367 —
Not listed Fort Collins Colorado 80528 —
Not listed Norwalk Connecticut 06856 —
Not listed Norwich Connecticut 06360 —
Not listed Stamford Connecticut 06902 —
Not listed Washington D.C. District of Columbia 20010 —
Not listed Boca Raton Florida 33486 —
Not listed Fernandina Beach Florida 32034 —
Not listed Fort Lauderdale Florida 33316 —
Not listed Fort Myers Florida 33916 —
Not listed Hollywood Florida 33021 —
Not listed Jacksonville Florida 32205 —
Not listed Jacksonville Florida 32207 —
Not listed Jacksonville Florida 32256 —
Not listed Jacksonville Florida 32258 —
Not listed Kissimmee Florida 34741 —
Not listed Lakeland Florida 33804-1057 —
Not listed Miami Florida 33133 —
Not listed Miami Florida 33136 —
Not listed Miami Florida 33176 —
Not listed Orange Park Florida 32073 —
Not listed Pembroke Pines Florida 33028 —
Not listed Athens Georgia 30607 —
Not listed Atlanta Georgia 30318 —
Not listed Atlanta Georgia 30322 —
Not listed Atlanta Georgia 30341 —
Not listed Atlanta Georgia 30342 —
Not listed Carrolton Georgia 30117 —
Not listed Cartersville Georgia 30121 —
Not listed Decatur Georgia 30033 —
Not listed Douglasville Georgia 30134 —
Not listed Macon Georgia 31217 —
Not listed Marietta Georgia 30060 —
Not listed Boise Idaho 83712 —
Not listed Meridian Idaho 83642 —
Not listed Nampa Idaho 83686 —
Not listed Post Falls Idaho 83854 —
Not listed Twin Falls Idaho 83301 —
Not listed Chicago Illinois 60612 —
Not listed Decatur Illinois 62526 —
Not listed Effingham Illinois 62526 —
Not listed Joliet Illinois 60435 —
Not listed Morris Illinois 60450 —
Not listed Peoria Illinois 61615-7828 —
Not listed Skokie Illinois 60076 —
Not listed Zion Illinois 60099 —
Not listed Bettendorf Iowa 52722 —
Not listed Wichita Kansas 67214-3728 —
Not listed Paducah Kentucky 42001 —
Not listed Covington Louisiana 70433 —
Not listed Lafayette Louisiana 70503 —
Not listed Marrero Louisiana 70072 —
Not listed Metairie Louisiana 70006 —
Not listed New Orleans Louisiana 70115 —
Not listed Kittery Maine 03904 —
Not listed Wells Maine 04090 —
Not listed York Village Maine 03909 —
Not listed Baltimore Maryland 21202 —
Not listed Baltimore Maryland 21237 —
Not listed Bethesda Maryland 20817 —
Not listed Rockville Maryland 20850 —
Not listed Boston Massachusetts 02114 —
Not listed Boston Massachusetts 02115 —
Not listed Boston Massachusetts 02118 —
Not listed Boston Massachusetts 02215 —
Not listed Burlington Massachusetts 01805 —
Not listed Peabody Massachusetts 01960 —
Not listed Brownstown Michigan 48183 —
Not listed Dearborn Michigan 48126 —
Not listed Detroit Michigan 48201 —
Not listed Detroit Michigan 48202 —
Not listed Saint Joseph Michigan 49085 —
Not listed West Bloomfield Michigan 48322 —
Not listed Edina Minnesota 55414 —
Not listed Maplewood Minnesota 55109 —
Not listed Minneapolis Minnesota 55454 —
Not listed Saint Louis Park Minnesota 55426 —
Not listed Saint Paul Minnesota 55101 —
Not listed City of Saint Peters Missouri 63110 —
Not listed City of Saint Peters Missouri 63376 —
Not listed Joplin Missouri 64804 —
Not listed Kansas City Missouri 64111 —
Not listed St Louis Missouri 63110 —
Not listed St Louis Missouri 63141 —
Not listed Missoula Montana 59802 —
Not listed Omaha Nebraska 68114 —
Not listed Henderson Nevada 89052 —
Not listed Cherry Hill New Jersey 08002 —
Not listed Hackensack New Jersey 07601 —
Not listed Morristown New Jersey 07962 —
Not listed Parsippany New Jersey 07054 —
Not listed Voorhees Township New Jersey 08043 —
Not listed Santa Fe New Mexico 87505 —
Not listed Brockport New York 14420 —
Not listed Canandaigua New York 14424 —
Not listed Fresh Meadows New York 11366 —
Not listed Geneva New York 14456 —
Not listed Greece New York 14626 —
Not listed Lake Success New York 11042 —
Not listed Mount Kisco New York 10549 —
Not listed Rochester New York 14626 —
Not listed Stony Brook New York 11794 —
Not listed Charlotte North Carolina 28203 —
Not listed Durham North Carolina 27710 —
Not listed Hickory North Carolina 28602 —
Not listed Kinston North Carolina 28501 —
Not listed Washington North Carolina 27889 —
Not listed Cleveland Ohio 44106 —
Not listed Cleveland Ohio 44195 —
Not listed Columbus Ohio 43215 —
Not listed Columbus Ohio 43219 —
Not listed Columbus Ohio 43228 —
Not listed Middletown Ohio 45042 —
Not listed Newark Ohio 43055 —
Not listed Sandusky Ohio 44870 —
Not listed Portland Oregon 97227 —
Not listed Philadelphia Pennsylvania 19106 —
Not listed Philadelphia Pennsylvania 19124 —
Not listed Pittsburgh Pennsylvania 15213 —
Not listed Pittsburgh Pennsylvania 15232 —
Not listed East Providence Rhode Island 02915 —
Not listed Columbia South Carolina 29210 —
Not listed North Charleston South Carolina 29425 —
Not listed Memphis Tennessee 38120 —
Not listed Nashville Tennessee 37203 —
Not listed Austin Texas 78731 —
Not listed Bryan Texas 77802 —
Not listed Cypress Texas 77429 —
Not listed Dallas Texas 75230 —
Not listed El Paso Texas 79902 —
Not listed Houston Texas 77090 —
Not listed Shenandoah Texas 77384 —
Not listed Temple Texas 76501 —
Not listed Fairfax Virginia 22031 —
Not listed Gig Harbor Washington 98332 —
Not listed Lakewood Washington 98499 —
Not listed Puyallup Washington 98372 —
Not listed Tacoma Washington 98405 —
Not listed Milwaukee Wisconsin 53226 —
Not listed Wausau Wisconsin 54401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 146 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00829166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 31, 2016 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00829166 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →