A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients

Fecha de inicio: 26 de septiembre de 1995

DISEASE CHARACTERISTICS: Female patients with Stage II, III or IV breast carcinoma in remission, and not eligible for protocols of higher priority (DM89-102) Stage II breast cancer must have spread to at least 10 axillary nodes; patients with fewer than 10 nodes must have extranodal extensions Patients with greater than 75% positive nodes for tumor are eligible No bone marrow involvement with tumor by standard histopathological exam of bilateral iliac marrow biopsies 2 weeks prior to study Prior normalization of markers needed in patients with elevated tumor markers (e.g., CEA) Metastatic disease patients must have documentation verifying at least 50% reduction of all sites of disease, except bone Stable bone metastases measured via bone scan are eligible Responsive disease but with large tumor burden should enter high risk BMT protocols (93-090) PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 No hematopoietic growth factor treatments Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal Renal: Estimated creatinine clearance greater than 60 mL/min Cardiovascular: Normal ejection fraction Pulmonary: DLCO greater than 50% of predicted Other: Not HIV positive Not pregnant 2 weeks prior to study No comorbid condition placing patient at high risk for complications No prior active infections No history of untreated central nervous system (CNS) disease No allergic response to eggs or murine protein PRIOR CONCURRENT THERAPY: No concurrent involvement in any other clinical trial that effects engraftment Biologic therapy: No growth factors within 1 week Chemotherapy: No more than 2 chemotherapy regimens allowed after relapse for metastatic disease Chemotherapy responsive disease prior to study Stage II/III disease receiving neoadjuvant chemotherapy allowed with at least 4 positive nodes at mastectomy No partial response to chemotherapy less than 50% of any site except bone No prior chemotherapy treatment with carmustine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Mastectomy allowed