Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy|
- Disease-free survival [ Time Frame: Every 12 months until breast cancer recurrence, second primary cancer or death from any cause. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Death from any cause ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: time from randomization to recurrence or contralateral second primary cancer ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2001|
|Study Completion Date:||February 2011|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
Experimental: Group 1
25 mg for 5 years
Placebo Comparator: Group 2
- 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.
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation, Inc.|