Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Breast Cancer Patients
The goal of this clinical research study is to learn if the combination of Femara (letrozole) and Gleevec (imatinib mesylate) can shrink or slow the growth of the tumor in patients who have hormonal sensitive advanced breast cancer.
- To determine the efficacy of Letrozole plus Imatinib Mesylate in patients with ER and or PgR positive metastatic breast cancer. Efficacy will be measured by the rate of clinical tumor response.
- To determine the safety and tolerability of Letrozole plus Imatinib Mesylate in patients with metastatic breast cancer.
- To determine the time to disease progression and overall survival in patients with metastatic breast cancer who are treated with Letrozole plus Imatinib Mesylate.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Postmenopausal Patients With ER and/or PR Positive Metastatic Breast Cancer|
- Overall Response [ Time Frame: Every week for first four weeks then every month, or until disease progression ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Letrozole + Imatinib Mesylate
Oral Letrozole 2.5 mg daily + Oral Imatinib Mesylate 400 mg, twice a day (total daily dose 800 mg).
Drug: Imatinib Mesylate
400 mg orally twice daily
Other Name: GleevecDrug: Letrozole
2.5 mg orally once daily
Other Name: Femara
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.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Banu Arun, MD||M.D. Anderson Cancer Center|