RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
OBJECTIVES: * Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer. * Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients. * Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients. * Evaluate the quality of life of a subset of these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral exemestane daily for 5 years. * Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years. Quality of life is assessed at baseline and then every 6 months for 5.5 years. Patients are followed every 6 months for 6 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,598
25 mg for 5 years
Placebo
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Disease-free survival
Time frame: Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.
Overall survival
Time frame: Death from any cause
Time to treatment failure
Time frame: time from randomization to recurrence or contralateral second primary cancer
Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement
Time frame: measurements taken at regular intervals from randomization through 6 years following randomiztion
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