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An Open-Label Study of Trastuzumab-MCC-DM1 (TDM-1) vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Active | 18 and over | TDM4370g
2008-005 713-22, NCT00829166 |
Trial Description
Summary This is a Phase III, randomized, multicenter, international, two-arm, open-label clinical trial designed to compare the safety and efficacy of T-DM1 with that of capecitabine + lapatinib for HER2-positive MBC. A total of 580 patients will be enrolled at approximately 260 sites worldwide. Eligible patients will be randomized in a 1:1 ratio to either T-DM1 or lapatinib + capecitabine. Eligibility Criteria Inclusion Criteria: - HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
- Histologically or cytologically confirmed invasive breast cancer
- Prior treatment for breast cancer must include both: a taxane, alone or in combination with another agent, and trastuzumab in the adjuvant, locally advanced, or metastatic setting
- Documented progression of incurable locally advanced or metastatic breast cancer, defined by the investigator
- Measurable and/or nonmeasurable disease
- Cardiac ejection fraction ≥ 50% by either ECHO or MUGA
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, two reliable barrier methods, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study according to local health authority guidelines
Exclusion Criteria: - History of treatment with T-DM1
- Prior treatment with lapatinib or capecitabine
- Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar outcome as those mentioned above
- History of receiving any chemotherapy or investigational treatment within 21 days prior to randomization and recovery of treatment-related toxicity consistent with other eligibility criteria
- History of radiation therapy within 14 days of randomization
- Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months of randomization
- History of symptomatic CHF or ventricular arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months of randomization
- Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
- Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, 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 dehydrogenase deficiency
- Current treatment with sorivudine or its chemically related analogs, such as brivudine
Trial Contact Information
Trial Lead Organizations/Sponsors Genentech Incorporated F. Hoffmann - La Roche, Limited
| Sam Agresta, M.D., M.P.H. | | Study Director |
| Genentech Trial Information Support Line | | Ph: 888-662-6728 |
Trial Sites
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00829166
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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