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View Clinical Trial (Medical Research Study)
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An Open-Label Study of Trastuzumab-MCC-DM1 (T-DM1) vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer - NCT00829166-53226 (Clinical Trial 316111)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy316111.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53226 |
| Conditions: |
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Metastatic Breast Cancer |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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)
- Pregnancy or lactation
- 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 |
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| Study is available at: |
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Medical College of Wisconsin
Milwaukee, WI 53226
United States
Primary Contact:
Lorna Rogahn
Email: lrogahn@mcw.edu
Phone: 414-805-4196
Secondary Contact:
Trial Information Support Line
Phone: 888-662-6728 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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If you would like to be
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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