Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00066573|
Recruitment Status : Completed
First Posted : August 7, 2003
Results First Posted : May 15, 2014
Last Update Posted : October 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: exemestane||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7576 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer|
|Actual Study Start Date :||June 2, 2003|
|Actual Primary Completion Date :||November 7, 2010|
|Actual Study Completion Date :||January 6, 2012|
Patients receive oral exemestane (25 mg) once daily for 5 years.
Active Comparator: Anastrozole
Patients receive oral anastrozole (1 mg) once daily for 5 years.
- 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: Percentage of Participants Alive at 5 Years [ Time Frame: 5 years ]Overall survival is defined as the time from randomization to the time of death from any cause.
- Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence [ Time Frame: 5 years ]Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.
- Clinical Fracture Rate: Number of Participants With Bone Fractures. [ Time Frame: 8 years ]Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066573
|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|