RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
OBJECTIVES: * Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen. * Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,672
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States
Disease-free Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.
Time frame: 5-year estimate reported at a median follow-up of 72 months
Breast Cancer-free Interval
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time frame: 5-year estimate reported at a median follow-up of 72 months
Distant Recurrence-free Interval
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up
Time frame: 5-year estimates reported at a median follow-up of 72 months
Overall Survival
Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Time frame: 8-year estimates, reported at a median follow-up of 9 years
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Sutter Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
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