Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer
- Registration Number
- NCT00066573
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7576
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exemestane exemestane Patients receive oral exemestane (25 mg) once daily for 5 years. Anastrozole anastrozole Patients receive oral anastrozole (1 mg) once daily for 5 years.
- Primary Outcome Measures
Name Time Method Event-free Survival 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.
- Secondary Outcome Measures
Name Time Method Clinical Fracture Rate: Number of Participants With Bone Fractures. 8 years Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.
Overall Survival: Percentage of Participants Alive at 5 Years 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 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.
Trial Locations
- Locations (39)
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Lethbridge Cancer Centre
🇨🇦Lethbridge, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
The Vitalite Health Network - Dr. Leon Richard
🇨🇦Moncton, New Brunswick, Canada
Scroll for more (29 remaining)Tom Baker Cancer Centre🇨🇦Calgary, Alberta, Canada