Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III 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, male breast cancer, Paget disease of the breast with invasive ductal carcinoma, invasive ductal breast carcinoma with predominant intraductal component, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, comedo ductal breast carcinoma, invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven infiltrating ductal or lobular breast carcinoma Stage II or III disease Inflammatory breast cancer allowed Hormone-receptor status not specified PATIENT CHARACTERISTICS: ECOG performance status < 2 Male or female Menopausal status not specified (for female patients) Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin normal (except for patient's with Gilbert's disease) Creatinine ≤ 1.2 mg/dL Creatinine clearance ≥ 70 mL/min Ejection fraction ≥ 50% on MUGA No neuropathy ≥ grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective nonhormonal contraception No prior malignant disease within the past 5 years, excluding: Squamous cell or basal cell skin carcinoma Stage I or in situ cervical carcinoma No noninvasive (in situ) breast carcinoma within the past 5 years PRIOR CONCURRENT THERAPY: At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor) No prior radiotherapy to the chest wall
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab
Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.