A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY
OBJECTIVES: I. Evaluate the effect on 3-year survival of intensive chemotherapy with
cyclophosphamide/thiotepa with peripheral blood stem cell rescue in women with locally
recurrent or metastatic breast cancer who respond to induction therapy with
epirubicin/fluorouracil/cyclophosphamide. II. Evaluate the effects of this intensive
treatment on patient quality of life. III. Evaluate tumor response and progression-free
survival after intensification.
OUTLINE: This is a randomized study. Patients are stratified by clinical/therapeutic hormone
sensitivity and participating institution. All patients receive induction therapy with
epirubicin, fluorouracil, and cyclophosphamide (FEC 100) every 3 weeks for up to 4 courses,
with response evaluated after at least 2 courses. Patients with a complete response or at
least a 50% partial response are randomized either to no further therapy or to receive
intensification chemotherapy. Patients randomized to intensification undergo peripheral
blood stem cell (PBSC) harvest with G-CSF mobilization after the third or fourth induction
course. Three to 6 weeks after induction, patients receive intensification chemotherapy with
cyclophosphamide/thiotepa followed by PBSC. Post-transplant G-CSF is given for hematopoietic
support. No concurrent hormonal therapy is permitted during induction; local irradiation of
multifocal tumors is allowed provided response is still evaluable. Local therapy (excision
of single metastasis, radiotherapy to metastatic site) is permitted after completion of
protocol therapy. Treatment of relapsed disease is at the discretion of the investigator.
Patients are followed every 3 months for 3 years or until relapse, then every 6 months.
PROJECTED ACCRUAL: A total of 180 patients will be accrued over 3 years in this multicenter
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Pierre Biron, MD
Study Chair
Centre Leon Berard
United States: Federal Government
CDR0000065151
NCT00002870
December 1994
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