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Sponsors and Collaborators: |
Novartis Chugai Pharmaceutical |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00237211 |
To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.
Condition | Intervention | Phase |
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Postmenopausal Women With Advanced Breast Cancer |
Drug: Letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of High-Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | June 2001 |
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Other protocol-defined inclusion / exclusion criteria may apply.
Study ID Numbers: | CFEM345F1201 |
Study First Received: | October 9, 2005 |
Last Updated: | July 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00237211 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Aromatase inhibitor letrozole breast cancer |
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 |