High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Combination Chemotherapy in Treating Women With High-Risk Breast Cancer

Filgrastim 10 mg/kg/d sc for 6 days after randomization.

Cyclophosphamide 100 mg/m2 orally days 1 - 14, methotrexate 40 mg/m2 iv days 1 and 8, 5-fluorouracil 600 mg/m2 iv days 1 and 8. Repeat every 28 days.

For high-dose EC arm: cyclophosphamide 4 gm/m2 iv as 4 divided doses. For standard chemotherapy arm: cyclophosphamide 600 mg/m2 iv day 1 of 21-day EC cycles, and cyclophosphamide 100 mg/m2 orally on days 1-14 of 28-day CMF cycles.

Doxorubicin 60 mg/m2 iv on day 1 of 21-day cycles of AC.

Epirubicin 90 mg/m2 iv on day 1 of 21-day cycles of EC.

5-fluorouracil 600 mg/m2 iv days 1 and 8 of 28-day cycles of CMF.

MESNA (7.2 gm/m2) on days 2 and 3 of 21-day cycles of dose-intensive EC.

Methotrexate 40 mg/m2 iv on days 1 and 8 of 28-day cycles of CMF.

Tamoxifen 20mg daily for 5 years or until relapse.

Peripheral blood progenitor cells (PBPC) infusion on day 5 of each 21-day cycle of dose-intensive EC.

Radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.

radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.