Trial Information

A Randomised Comparative Trial of Highly Intensive Chemotherapy With Stem Cell Support vs. Relatively Intensive Chemotherapy (CMF 8 Cycles) in Breast Cancer Patients Node Positive Surgery, Having Received Primary Medical Therapy With an Anthracycline Regimen

OBJECTIVES: I. Compare the overall survival in locally advanced, inflammatory, or operable
large primary breast cancer (greater than 3 cm) patients with positive axillary lymph nodes
at surgery following primary chemotherapy, receiving either conventional chemotherapy or
high dose chemotherapy as adjuvant therapy. II. Compare the relapse-free survival and
quality of life in these patients receiving this therapy.

OUTLINE: This is a randomized, multicenter, open label study. Patients are stratified by
study center and number of positive axillary lymph nodes at surgery. Patients are randomized
to receive conventional or high dose adjuvant chemotherapy. Arm I: Patients receive
conventional chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil IV
administered once every 3 weeks for 8 courses. Arm II: Patients receive high dose
chemotherapy. Cyclophosphamide IV is administered on day 1. Patients undergo peripheral
blood progenitor cell (PBPC) collection, then receive cyclophosphamide and thiotepa IV for 4
days, 13-28 days after PBPC collection. Peripheral blood progenitor cells are then
reinfused. Patients undergo radiotherapy during or after chemotherapy and receive oral
tamoxifen for 5 years, beginning at the same time as radiotherapy. Estrogen receptor
negative patients may receive tamoxifen at the discretion of the treating physician. Quality
of life is assessed before chemotherapy, then at 6, 12, and 24 months. Patients are followed
at 12, 18, and 24 months, then annually for 5 years or until death.

PROJECTED ACCRUAL: This study will accrue approximately 300 patients.