Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:July 2003

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Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

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.


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 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 scan or
echocardiogram

- HER-2/neu status is determined by a FISH 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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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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4018 W Capitol Ave.
Little Rock, Arkansas 72205
(501) 296-1200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
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Pomona, CA
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