Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the
administration of a course of adjuvant tamoxifen or ablation of ovarian function results in
prolongation of time to recurrence or death in patients under 50 years of age with operable
carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual
functioning in these patients.
OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are
randomized following primary therapy, which, in addition to surgery, may include local
irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide,
methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to
randomize patients to all groups or to only those groups including tamoxifen. The first
group receives no further therapy. Then second group receives tamoxifen daily for at least 2
years. The third group receives ovarian ablation with goserelin via monthly injection for at
least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen
for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months
for 3 years, then annually.
PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.
Primary Purpose: Treatment
Michael Baum, MD, ChM, FRCS
University College London Hospitals
United States: Federal Government