Breast Cancer Clinical Trial
Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
Eligibility Criteria
Inclusion Criteria:
Confirmed infiltrating adenocarcinoma of the breast
Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
No prior radiation to the involved breast
ECOG (Electrocochleography) performance status 0-2
Age 18 years to 80 years
Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
All liver function tests < upper limit of normal
Serum creatinine < 2.0 mg/dl
Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram
HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]
If female of childbearing potential, pregnancy test is negative
If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
Informed consent has been obtained
Exclusion Criteria:
Non-confirmed infiltrating adenocarcinoma breast cancer
Evidence of metastasis
Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
Prior radiation to the involved breast
Recent breast cancer drug therapy within last 5 years of any form
History of allergy to polysorbate or castor oil
Ongoing active infection
Concurrent life-limiting disease with a life expectancy of less than one year
Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
Pregnancy, nursing, fertile women who do not use birth control device
Inability to give informed consent
Patients with pre-existing peripheral neuropathy > grade 2
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There are 4 Locations for this study
Little Rock Arkansas, 72205, United States
Los Angeles California, 90089, United States
Los Angeles California, 90095, United States
Pomona California, 91767, United States
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