A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors
OBJECTIVES:
- Compare adjuvant letrozole vs tamoxifen administered for 5 years in postmenopausal
women with operable, hormone receptor-positive breast cancer.
- Compare these treatment regimens given sequentially vs continuously in this patient
population.
- Compare these treatment regimens in terms of overall survival, disease-free and
systemic-free survival, safety, and tolerability in this patient population.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to adjuvant chemotherapy (prior therapy vs no prior or concurrent therapy vs
concurrent therapy), prior surgery (modified radical mastectomy vs a lesser surgical
procedure), and participating center. Patients are randomized to one of four treatment arms.
- Arm I: Patients receive adjuvant oral tamoxifen daily for 5 years.
- Arm II: Patients receive adjuvant oral letrozole daily for 5 years.
- Arm III: Patients receive adjuvant oral tamoxifen daily for 2 years followed by
adjuvant oral letrozole daily for 3 years.
- Arm IV: Patients receive adjuvant oral letrozole daily for 2 years followed by adjuvant
oral tamoxifen daily for 3 years.
Patients may receive concurrent radiotherapy. Some patients receive concurrent adjuvant
chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6
months.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 5,180 patients (1,295 per treatment arm) will be accrued for
this study within 6 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Disease free survival.
Time from randomization to recurrence (including recurrence restricted to the breast after breast conserving treatment), metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
Until patient's death (lifelong follow-up).
No
Beat Thurlimann, MD
Study Chair
Kantonsspital St. Gallen
Australia: Department of Health and Ageing Therapeutic Goods Administration
CDR0000067451
NCT00004205
March 1998
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