Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IIIB breast cancer, inflammatory breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin Diagnosis within the past 6 months PATIENT CHARACTERISTICS: Age: 60 and under Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT or SGPT no greater than 1.5 times the upper limit of normal Renal: Creatinine less than 1.2 mg/dL Creatinine clearance at least 80 mL/min No history of hemorrhagic cystitis Cardiovascular: Left ventricular fraction at least 55% on MUGA scan No previous valvular heart disease or arrhythmia Pulmonary: FEV_1 at least 60% predicted Room air pO_2 greater than 85 mmHg Room air pCO_2 no greater than 43 mmHg DLCO at least 60% of the lower limit of predicted value Other: No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer No organic CNS dysfunction Not pregnant No known and potentially disabling psychosocial history Not positive for hepatitis B or HIV PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Stratum 1: No more than one cycle of chemotherapy Stratum 2: No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel during previous chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation to the left chest wall Surgery: Modified radical mastectomy allowed
Sites / Locations
- City of Hope Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1 cycle of neoadjuvant chemotherapy
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.