Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
- Registration Number
- NCT00016432
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1598
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 2 Placebo Placebo Group 1 exemestane Exemestane
- Primary Outcome Measures
Name Time Method Disease-free survival Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.
- Secondary Outcome Measures
Name Time Method Overall survival Death from any cause Time to treatment failure time from randomization to recurrence or contralateral second primary cancer Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement measurements taken at regular intervals from randomization through 6 years following randomiztion
Trial Locations
- Locations (162)
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
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Scripps Cancer Center
🇺🇸La Jolla, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Cancer Institute
🇺🇸Loma Linda, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Scroll for more (152 remaining)Comprehensive Cancer Institute of Huntsville🇺🇸Huntsville, Alabama, United States