Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,172
2.5 mg tablets
1 mg tablets
Disease Free Survival
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
Time frame: 84 months
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time frame: 84 months
Time to Development of Distant Metastases
Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
Time frame: 84 months
Time to Development of Contra Lateral Breast Cancer
Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
Time frame: 84 months
Distant Disease-free Survival
Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
Time frame: 84 months
Change From Baseline in Serum Lipid Profiles
Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
Time frame: baseline, 6, 12, 24, 36, 48 and 60 months
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Percentage of Participants Who Experienced Clinical Fracture Events
The incidence of clinical fractures was analyzed.
Time frame: 84 months
Percentage of Participants Who Experienced Cardiovascular Events
The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Time frame: 84 months