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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00338728 |
Primary Objectives:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Imatinib Mesylate Drug: Letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Postmenopausal Patients With ER and/or PR Positive Metastatic Breast Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Letrozole + Imatinib Mesylate
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Drug: Imatinib Mesylate
400 mg PO Twice Daily
Drug: Letrozole
2.5 mg PO Once Daily
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Letrozole is an antihormonal drug used in the standard treatment of advanced hormonal sensitive breast cancer. Imatinib mesylate is a drug (not chemotherapy) that binds to certain proteins on the tumor cells and prevents them from further growth. Imatinib mesylate is thought to prevent the potential resistance to letrozole, which may make the letrozole more effective.
Before the treatment starts, you will have blood tests (2-4 teaspoons), CT scans of your chest and abdomen, and a bone scan. Blood tests (2-4 teaspoons) will be repeated every week for 4 weeks and then every month for the length of the study. The blood tests are done to evaluate how the drug affects breast cancer related markers in the blood. These blood tests will be done at screening, and then at Months 2 and 4. The CT scans will be repeated every 2 months as is standard for your care.
You will take letrozole once a day by mouth and imatinib mesylate twice a day by mouth until intolerable side effects occur or until your tumor grows further. You will stop the treatment if your tumor grows or intolerable side effects occur.
This is an investigational study. Letrozole is FDA approved for the treatment of advanced breast cancer and is commercially available. Imatinib mesylate is approved for chronic myelogenous leukemia and is being investigated for use in the treatment of breast cancer. A total of 45 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T. M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Banu Arun, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Banu Arun, MD/Associate Professor ) |
Study ID Numbers: | 2003-0384 |
Study First Received: | June 16, 2006 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00338728 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Letrozole Imatinib Mesylate Gleevec Femara |
Imatinib Skin Diseases Breast Neoplasms Letrozole Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Aromatase Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |