Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer|
- Event-free Survival [ Time Frame: 5 years ]Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.
- Overall Survival [ Time Frame: 8 years ]
- Distant Disease-free Survival [ Time Frame: 8 years ]
- New Primary Breast Cancer [ Time Frame: 8 years ]
- Clinical Fracture Rate [ Time Frame: 8 years ]
- Cardiovascular Morbidity and Mortality [ Time Frame: 8 years ]
|Study Start Date:||June 2003|
|Study Completion Date:||March 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral exemestane (25 mg) once daily for 5 years.
Active Comparator: Arm II
Patients receive oral anastrozole (1 mg) once daily for 5 years.
- Compare the event-free survival of postmenopausal women with receptor-positive primary breast cancer when treated with exemestane vs anastrozole.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to distant recurrence in patients treated with these regimens.
- Compare the incidence of new primary contralateral breast cancer in patients treated with these regimens.
- Compare the incidence of all clinical fractures, specifically hip and vertebral fractures, in patients treated with these regimens.
- Compare cardiovascular morbidity and mortality (i.e., significant coronary heart disease, which includes myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes, and all vascular deaths) in patients treated with these regimens.
- Correlate therapy induced changes in breast density with plasma hormones and growth factors, drug levels of exemestane and anastrozole, genetic variation and breast cancer recurrence or contralateral events in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph node status at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and herceptin use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral exemestane (25 mg) once daily for 5 years.
- Arm II: Patients receive oral anastrozole (1 mg) once daily for 5 years. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months during the first year of study participation and annually thereafter.
PROJECTED ACCRUAL: A total of 6,840 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066573
Show 39 Study Locations
|Study Chair:||Paul E. Goss, MD, PhD||Massachusetts General Hospital|
|Study Chair:||James N. Ingle, MD||Mayo Clinic|
|Study Chair:||Matthew J. Ellis, MD, PhD, FRCP||Washington University Siteman Cancer Center|
|Study Chair:||George W. Sledge, MD||Indiana University Melvin and Bren Simon Cancer Center|
|Study Chair:||George T. Budd, MD||The Cleveland Clinic|
|Principal Investigator:||Manuela Rabaglio, MD||University Hospital Inselspital, Berne|