S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: filgrastimRadiation: radiation therapyProcedure: autologous bone marrow transplantationProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00002772
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.
- Detailed Description
OBJECTIVES: I. Compare disease free survival and overall survival in women with operable breast cancer and at least 4 positive axillary lymph nodes treated with intensive sequential chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide versus standard dose doxorubicin and cyclophosphamide followed by high dose STAMP I (cyclophosphamide, cisplatin, and carmustine) or STAMP V (cyclophosphamide, carboplatin, and thiotepa) and autologous stem cell rescue. II. Compare the toxic effects of these regimens in this patient population. III. Measure the breast cancer cell content of the peripheral blood progenitor cell (PBPC) fractions from patients randomized to the PBPC supported arm and correlate the results with the disease free survival, survival, and pattern of relapse in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, primary treatment (mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast conserving surgery plus radiotherapy following chemotherapy), menopausal status (premenopausal vs postmenopausal), estrogen and/or progesterone receptor status (positive vs negative vs unknown), N2 disease (yes vs no), T3 disease (yes vs no), myeloablative chemotherapy regimen (STAMP I vs STAMP V), and source of progenitor cells (marrow vs peripheral blood vs both). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive doxorubicin IV over 1 hour on days 1, 15, and 29, paclitaxel IV over 24 hours on days 43, 57, and 71, and cyclophosphamide IV over 1 hour on days 85, 99, and 113. Patients receive filgrastim (G-CSF) subcutaneously on days 3-10, 17-24, 31-38, 45-52, 59-66, 73-80, 87-94, 101-108, and 115-122. Arm II: Mobilization chemotherapy: Patients receive doxorubicin IV over 1 hour and cyclophosphamide IV over 1 hour on days 1, 22, 43, and 64. Harvest: Patients undergo harvest of autologous bone marrow and/or peripheral blood stem cells (PBSC). Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy but receive hematopoietic growth factors prior to harvest. High dose myeloablative chemotherapy: Patients receive STAMP I OR STAMP V: STAMP I: Patients receive cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and carmustine IV over 2 hour on day -3. STAMP V: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. Transplantation: Autologous bone marrow and/or PBSC are reinfused on day 0. Both arms: Patients who are postmenopausal or who have hormone receptor positive disease receive oral tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5 years. Patients who underwent breast conserving surgery receive locoregional radiotherapy 5 days a week for 4.5-5.5 weeks beginning 4-6 weeks after the completion of chemotherapy. Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5 days a week for 5 weeks at the discretion of their physician. Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 602
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose chemo filgrastim sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support High dose chemo cyclophosphamide sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support High dose chemo doxorubicin hydrochloride sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support High dose chemo tamoxifen citrate sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support High dose chemo radiation therapy sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support chemo with autologous stem cell support carboplatin conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support paclitaxel conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support tamoxifen citrate conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support thiotepa conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support autologous bone marrow transplantation conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support peripheral blood stem cell transplantation conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support High dose chemo paclitaxel sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support chemo with autologous stem cell support carmustine conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support cisplatin conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support cyclophosphamide conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support chemo with autologous stem cell support doxorubicin hydrochloride conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States