The goal of this clinical research study is to learn if exemestane and everolimus combined with metformin can help to control breast cancer in patients who are obese or overweight and post-menopausal with hormone-receptor-positive breast cancer that has spread to other parts of the body.
Exemestane is designed to decrease the ability of estrogen to help cancer cells grow. This could cause the cancer cells to die.
Metformin is commonly used to control blood sugar levels in patients with diabetes. It is designed to lower insulin levels, which may slow or stop the growth of breast cancer cells.
Everolimus is designed to block cells from dividing. This may cause cancer cells to die. Everolimus may also stop the growth of new blood vessels that help tumors grow.
|Breast Cancer||Drug: Everolimus Drug: Exemestane Drug: Metformin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Circulating FGF21 Levels and Efficacy of Exemestane, Everolimus and Metformin in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer and BMI >/= 25|
- Progression-Free Survival (PFS) [ Time Frame: 2 months ]Progression-free survival (PFS), defined as time from date of registration to date of first documented progression or death due to any cause. Tumor response assessed every 8 weeks (± 1 week) until disease progression and until further anti-cancer therapy is initiated.
|Actual Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2019|
|Estimated Primary Completion Date:||September 2019 (Final data collection date for primary outcome measure)|
Experimental: Everolimus + Exemestane + Metformin
Patients take one 25 mg tablet of exemestane once daily, everolimus 10 mg orally per day and metformin 500 mg orally per day for three days. If there are no dose limiting toxicities, dose of metformin will be increased by 500 mg orally every three days to reach the target dose of 1,000 mg orally twice daily. Drugs will be taken immediately after a meal at the same time each day.
10 mg by mouth once daily.
Other Names:Drug: Exemestane
25 mg by mouth once daily.
Other Name: AromasinDrug: Metformin
500 mg by mouth per day for three days. If there are no dose limiting toxicities, the dose of metformin will be increased by 500 mg orally every three days to reach the target dose of 1,000 mg orally twice daily.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01627067
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vicente Valero, MD||M.D. Anderson Cancer Center|