letrozole
Drug2.5 mg tablets
NCT Number: NCT00248170
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.
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Notify Me33 year–96 year
Female
Interventional
Phase 3
Novartis Investigative Site, Garran, Australian Capital Territory, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
2.5 mg tablets
1 mg tablets
Time frame: 84 months
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 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 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 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 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: baseline, 6, 12, 24, 36, 48 and 60 months
Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
Time frame: 84 months
The incidence of clinical fractures was analyzed.
Time frame: 84 months
The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Novartis Pharmaceuticals
Industry
Acronym: FACE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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