Phase II Study of Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Postmenopausal Patients With ER and/or PR Positive Metastatic Breast Cancer
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response
Every week for first four weeks then every month, or until disease progression
No
Banu Arun, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2003-0384
NCT00338728
October 2003
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |