Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer, meeting 1 of the following stage criteria: Stage IIB (T3, N0) Stage IIIA (N0-N2) Stage IIIB (T4, N0-2) Stage IIIC Inflammatory breast cancer HER2/neu-positive disease by fluorescence in situ hybridization Biopsy-accessible tumor Measurable disease by physical examination or x-ray No stage IV disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status ECOG 0-2 Life expectancy At least 8 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Meets 1 of the following criteria: SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN Bilirubin normal Renal Creatinine normal No pre-existing clinically significant renal disease that is not related to the malignancy Cardiovascular Ejection fraction ≥ 50% by MUGA No pre-existing clinically significant cardiac disease that is not related to the malignancy No history of congestive heart failure Pulmonary No pre-existing clinically significant pulmonary disease that is not related to the malignancy Gastrointestinal No severe malnutrition No intractable emesis Neurologic No pre-existing clinically significant neurologic disease that is not related to the malignancy No peripheral neuropathy ≥ grade 2 No nerve damage from diabetes Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective non-hormonal contraception during and for 4 weeks after completion of study treatment No known allergic reaction to study drugs No active infection No other malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other pre-existing clinically significant disease that is not related to the malignancy No other serious or significant medical condition that would preclude study participation No other contraindication to study treatment PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent immunotherapy Chemotherapy No prior chemotherapy for the malignancy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy for the malignancy Radiotherapy No concurrent radiotherapy Surgery No concurrent surgery for the malignancy Other More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing products No other concurrent investigational or commercial agents or therapies for the malignancy
Sites / Locations
- Central Jersey Oncology Center, PA - East Brunswick
- CentraState Medical Center
- Cancer Institute of New Jersey at Hamilton
- Mountainside Hospital Cancer Center
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Saint Peter's University Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- UMDNJ University Hospital
- Overlook Hospital
Arms of the Study
Arm 1
Experimental
Docetaxel, Carboplatin and Trastuzumab
A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged. Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.