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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00237224 |
To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Letrozole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole |
Estimated Enrollment: | 280 |
Study Start Date: | February 2003 |
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Clinical stage *T2, T3, T4a,b,c, N0, 1 or 2, M0
Post menopausal status defined by one of the following:
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CFEM345EMX01 |
Study First Received: | October 9, 2005 |
Last Updated: | August 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00237224 |
Health Authority: | Mexico: Federal Commission for Protection Against Health Risks |
Breast Cancer, ER and/or PgR positive, Letrozole |
Skin Diseases Breast Neoplasms Letrozole Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |