A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer
OBJECTIVES:
Primary
- Compare the event-free survival of postmenopausal women with receptor-positive primary
breast cancer when treated with exemestane vs anastrozole.
Secondary
- 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Event-free survival
8 years
No
Paul E. Goss, MD, PhD
Study Chair
Massachusetts General Hospital
Canada: Health Canada
MA27
NCT00066573
June 2003
March 2011
Name | Location |
---|