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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00330317 |
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: letrozole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Neoadjuvant Hormone Therapy for Postmenopausal Women With ER and/or PgR Positive Primary Breast Cancer: A Multi-Center Study to Determine the Optimum Length of Treatment With Letrozole (2.5 mg Daily) on Tumour Regression to Permit Breast Conserving Surgery |
Estimated Enrollment: | 300 |
Study Start Date: | February 2006 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Postmenopausal status defined by one of the following:
Women with an intact uterus AND
Women without an intact uterus AND
Adequate bone marrow function as shown by:
Exclusion Criteria:
The following additional treatments are NOT allowed during the treatment phase of the study:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Sunjeet Sawhney | 01276 698 8760 |
United Kingdom | |
Recruiting | |
West Smithfield, United Kingdom | |
Recruiting | |
Liverpool, United Kingdom | |
Recruiting | |
Manchester, United Kingdom | |
Recruiting | |
Bristol, United Kingdom | |
Recruiting | |
Bournemouth, United Kingdom | |
Recruiting | |
Dundee, United Kingdom | |
Recruiting | |
Glasgow, United Kingdom | |
Recruiting | |
Hants, United Kingdom | |
Recruiting | |
London, United Kingdom | |
Recruiting | |
Luton, United Kingdom | |
Recruiting | |
Newcastle, United Kingdom | |
Recruiting | |
East Sussex, United Kingdom | |
Recruiting | |
Leicester, United Kingdom | |
Recruiting | |
Brighton, United Kingdom | |
Recruiting | |
Crewe, United Kingdom | |
Recruiting | |
Gateshead, United Kingdom | |
Recruiting | |
Farnworth, United Kingdom | |
Recruiting | |
Epping, United Kingdom | |
Recruiting | |
St. Leonards on Sea, United Kingdom | |
Recruiting | |
Poole, United Kingdom |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CFEM345EGB07 |
Study First Received: | May 24, 2006 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00330317 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Letrozole Breast Conserving Surgery NeoAdjuvant Early 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 |