RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.
OBJECTIVES: Primary * Determine the antitumor activity of trastuzumab (Herceptin\^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer. Secondary * Determine the pathological complete response in patients treated with this regimen. * Determine the disease-free survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. * Course 1 (days 1-28): Patients receive trastuzumab (Herceptin\^®) IV over 30-90 minutes on days 1, 8, 15, and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8. * Course 2-6: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 during courses 2-5 and on days 1, 8, 15, and 22 during course 6. Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 5 additional courses (6 courses total) in the absence of disease progression or unacceptable toxicity. Three weeks after completion of course 6, patients undergo restaging. Patients with local operable disease undergo modified radical mastectomy or lumpectomy and axillary node dissection followed by radiotherapy. Patients also receive trastuzumab IV once every 3 weeks for up to 52 weeks of total treatment (including the 6 courses of trastuzumab, docetaxel, and carboplatin) in the absence of disease progression or unacceptable toxicity. Patients who do not have local operable disease continue to receive trastuzumab as above. PROJECTED ACCRUAL: A total of 13-43 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Modified radical mastectomy or lumpectomy and axillary node dissection
Whole breast or chest wall irradiation (as determined by radiologist)
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States
CentraState Medical Center
Freehold, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
UMDNJ University Hospital
Newark, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Antitumor Activity as Measured by Response Rate
Time frame: 5 years
Pathological Complete Response
Time frame: 5 years
Disease-free Survival
Time frame: 10 years
Pathologic and Molecular Markers for Predicting Efficacy
Time frame: 5 years
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