Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Letrozole
* Drug: Anastrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent primary surgery for breast cancer Early stage breast cancer Postmenopausal Hormone receptor positive Positive lymph node involvement Exclusion Criteria: Metastatic disease Presence of contralateral breast cancer including DCIS Progression Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 33 Years
Maximum Age: 96 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br>2.5 mg by mouth (p.o.) once daily | Drug: Letrozole<br>* 2.5 mg tablets<br>|
| Active Comparator: Anastrozole<br>1 mg p.o. once daily | Drug: Anastrozole<br>* 1 mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 84 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death from any cause. | 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. | 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. | 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. | 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. | baseline, 6, 12, 24, 36, 48 and 60 months | 
| Percentage of Participants Who Experienced Clinical Fracture Events | The incidence of clinical fractures was analyzed. | 84 months | 
| Percentage of Participants Who Experienced Cardiovascular Events | The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed. | 84 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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letrozole, Breast cancer, anastrozole, adjuvant, postmenopausal, FACE