Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.
OBJECTIVES: I. Compare overall survival and local and systemic disease-free survival
produced by adjuvant chemoendocrine therapy with 4 courses of anthracycline/cyclophosphamide
and concurrent vs. sequential tamoxifen (TMX) or toremifene (TOR) in peri- and
postmenopausal women with node-positive breast cancer who are considered suitable for
endocrine therapy alone. II. Evaluate these same endpoints in patients randomized to
chemoendocrine therapy vs. endocrine therapy alone. III. Evaluate these same endpoints in
patients randomized to TMX vs. TOR as the endocrine therapy agent. IV. Compare the quality
of life of patients treated on these regimens. V. Compare the toxic effects of these
OUTLINE: This is a randomized study. Patients are stratified by type of primary therapy and
participating institution. Therapy must begin within 6 weeks of surgery. Patients in the
first group receive doxorubicin (or epirubicin) and cyclophosphamide every 28 days for a
total of 4 cycles and oral tamoxifen daily for 5 years, beginning day 1 of chemotherapy.
Patients in the second group receive the same chemotherapy with oral tamoxifen initiated on
day 8 of the fourth chemotherapy cycle and continued for 5 years. Patients in the third
group receive oral tamoxifen daily for 5 years. Patients in the fourth group are treated the
same as the first group, only tamoxifen is replaced by toremifene. Patients in the fifth
group are treated the same as the second group, only tamoxifen is replaced by toremifene.
Patients in the sixth group receive oral toremifene daily for 5 years. The timing of
optional radiotherapy for patients with less than total mastectomy in each group is based on
institutional policy; radiotherapy is administered for 5-6 weeks to the remaining breast
tissue, chest wall, and lung. Patients are followed every 3 months for 1 year, every 6
months for 2 years, and yearly thereafter.
PROJECTED ACCRUAL: 1,140 patients will be accrued over approximately 9 years, with 1
additional year of follow-up.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time from randomization to death.
17 years after randomization
Edda Simoncini, MD
Spedali Civili di Brescia
United States: Federal Government