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

Last updated: September 10, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Lapatinib

Capecitabine

Trastuzumab emtansine

Clinical Study ID

NCT00829166
BO21977
TDM4370g
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HER2 status must be prospectively, centrally tested and be HER2-positive based oncentral laboratory assay results

  • Histologically or cytologically confirmed invasive breast cancer

  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, ormetastatic setting must include both a taxane, alone or in combination with anotheragent, and trastuzumab, alone or in combination with another agent

  • Documented progression (which occur during or after most recent treatment or within 6months after completing of adjuvant therapy) of incurable, unresectable, locallyadvanced or metastatic breast cancer, defined by the investigator

  • Measurable and/or nonmeasurable disease; participants with central nervous system-onlydisease are excluded

  • Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by eitherechocardiogram or multi-gated acquisition scan

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • For women of childbearing potential and men with partners of childbearing potential,agreement to use a highly effective, non-hormonal form of contraception; contraceptionuse should continue for the duration of the study treatment and for at least 6 monthsafter the last dose of study treatment

Exclusion

Exclusion Criteria:

  • History of treatment with trastuzumab emtansine

  • Prior treatment with lapatinib or capecitabine

  • Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI-CTCAE), Version 3.0

  • History of other malignancy within the last 5 years, except for appropriately treatedcarcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer,synchronous or previously diagnosed HER2-positive breast cancer, or cancers with asimilar curative outcome as those mentioned above

  • History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7days prior to randomization; recovery of treatment-related toxicity consistent withother eligibility criteria

  • History of radiation therapy within 14 days of randomization

  • Brain metastases that are untreated, symptomatic, or require therapy to controlsymptoms, as well as any history of radiation, surgery, or other therapy, includingsteroids, to control symptoms from brain metastases within 2 months (60 days) ofrandomization

  • History of symptomatic congestive heart failure or serious cardiac arrhythmiarequiring treatment

  • History of myocardial infarction or unstable angina within 6 months of randomization

  • Current dyspnea at rest due to complications of advanced malignancy or currentrequirement for continuous oxygen therapy

  • Current severe, uncontrolled systemic disease (for example, clinically significantcardiovascular, pulmonary, or metabolic disease)

  • Pregnancy or lactation

  • Current known active infection with human immunodeficiency virus (HIV), hepatitis Bvirus, or hepatitis C virus

  • Presence of conditions that could affect gastrointestinal absorption: Malabsorptionsyndrome, resection of the small bowel or stomach, and ulcerative colitis

  • History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab

  • Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenasedeficiency

  • Current treatment with sorivudine or its chemically related analogs, such as brivudine

Study Design

Total Participants: 991
Treatment Group(s): 3
Primary Treatment: Lapatinib
Phase: 3
Study Start date:
February 01, 2009
Estimated Completion Date:
September 30, 2015

Connect with a study center

  • Banja Luka, 78000
    Bosnia and Herzegovina

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  • Sarajewo, 71000
    Bosnia and Herzegovina

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    Brazil

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    Belo Horizonte, Mg, 30150-281
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    Brazil

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    Itajaí, 88301220
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    Itajaí, 88301220
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    JAÚ, 17210-080
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    JAÚ, 17210-120
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  • Joao Pessoa, 58040280
    Brazil

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  • Porto Alegre, 90430-090
    Brazil

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  • Porto Alegre - Rs, 90050-170
    Brazil

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  • Rio de Janeiro, 20560-120
    Brazil

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  • Santo Andre, 09060-870
    Brazil

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  • Sao Paulo, 01317-000
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  • Plovdiv, 4000
    Bulgaria

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  • Sofia, 1756
    Bulgaria

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  • Varna, 9002
    Bulgaria

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  • Calgary, Alberta T2N 4N2
    Canada

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  • Edmonton, Alberta T6G 1Z2
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  • Kelowna, British Columbia V1Y 5L3
    Canada

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  • Norwalk, Connecticut 06856
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  • Stamford, Connecticut 06902
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  • Boca Raton, Florida 33486
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  • Fort Myers, Florida 33916
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  • Hollywood, Florida 33021
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  • Jacksonville, Florida 32207
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  • Kissimmee, Florida 34741
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  • Lakeland, Florida 33804-1057
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  • Miami, Florida 33136
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  • Atlanta, Georgia 30322
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  • Effingham, Illinois 62526
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  • Morris, Illinois 60450
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  • Peoria, Illinois 61615-7828
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  • Zion, Illinois 60099
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  • Bettendorf, Iowa 52722
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  • Wichita, Kansas 67214-3728
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  • Paducah, Kentucky 42001
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  • Covington, Louisiana 70433
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  • Lafayette, Louisiana 70503
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  • Marrero, Louisiana 70072
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  • Wells, Maine 04090
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  • Baltimore, Maryland 21202
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  • Rockville, Maryland 20850
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  • Brownstown, Michigan 48183
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  • Minneapolis, Minnesota 55454
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  • Saint Louis, Missouri 63110
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  • St. Louis, Missouri 63141
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  • Missoula, Montana 59802
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  • Omaha, Nebraska 68114
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  • Henderson, Nevada 89052
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  • Cherry Hill, New Jersey 08002
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  • Hackensack, New Jersey 07601
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  • Parsippany, New Jersey 07054
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  • Voorhees, New Jersey 08043
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  • Santa Fe, New Mexico 87505
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  • Brockport, New York 14420
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  • Canandaigua, New York 14424
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  • Fresh Meadows, New York 11366
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  • Geneva, New York 14456
    United States

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  • Greece, New York 14626
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  • Lake Success, New York 11042
    United States

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  • Mount Kisco, New York 10549
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    New Hyde Park, New York 11042
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  • Rochester, New York 14626
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  • Stony Brook, New York 11794
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  • Charlotte, North Carolina 28203
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  • Durham, North Carolina 27710
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  • Hickory, North Carolina 28602
    United States

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  • Kinston, North Carolina 28501
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  • Washington, North Carolina 27889
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  • Cleveland, Ohio 44195
    United States

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  • Columbus, Ohio 43219
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    Granville, Ohio 43023
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  • Sandusky, Ohio 44870
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  • Portland, Oregon 97227
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  • Philadelphia, Pennsylvania 19124
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  • Pittsburgh, Pennsylvania 15213
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  • East Providence, Rhode Island 02915
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    Charleston, South Carolina 29425
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  • North Charleston, South Carolina 29425
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  • Memphis, Tennessee 38120
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  • Nashville, Tennessee 37203
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  • Austin, Texas 78731
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  • Bryan, Texas 77802
    United States

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  • Cypress, Texas 77429
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  • Dallas, Texas 75230
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  • El Paso, Texas 79902
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  • Houston, Texas 77090
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  • Shenandoah, Texas 77384
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  • Temple, Texas 76501
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  • Fairfax, Virginia 22031
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  • Gig Harbor, Washington 98332
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  • Milwaukee, Wisconsin 53226
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  • Wausau, Wisconsin 54401
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