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Exemestane-RAD001-Metformin | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Exemestane-RAD001-Metformin

Circulating FGF21 Levels and Efficacy of Exemestane, Everolimus and Metformin in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer and BMI >/= 25

NCT01627067•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Study Drug Administration: If you are found to be eligible to take part in this study, you will take an exemestane and everolimus tablet by mouth every day. You will also take tablets of metformin by mouth 2 times a day. The drugs should be taken at about the same time each day. The study drugs will be given in 28-day cycles. Study Visits: On Day 1: * You will have a physical exam, including a measurement of your weight and vital signs. * You will be asked about any side effects you may be having. * You will be asked about any drugs you may have taken or may be taking. * Your performance status will be recorded. * Blood (about 1-2 teaspoons) will be drawn for routine tests. * Blood (about 1 teaspoon) will be drawn for blood sugar tests. If you have a history of diabetes, you will need to fast for 8 hours before these blood sugar tests. At Weeks 4 and 12: * You will have a physical exam, including a measurement of your vital signs. * You will be asked about any side effects you may be having. * You will be asked about any drugs you may have taken or may be taking. * Blood (about 1-2 teaspoons) will be drawn for routine tests. * Blood (about 1 teaspoon) will be drawn for blood sugar tests. If you have a history of diabetes, you will need to fast for 8 hours before these blood sugar tests. At Weeks 8, 16 and then every 2 months after that, and after your last dose of study drugs: * You will have a physical exam, including a measurement of your vital signs. * You will be asked about any side effects you may be having. * You will be asked about any drugs you may have taken or may be taking. * Blood (about 1-2 teaspoons) will be drawn for routine tests. * Blood (about 4 teaspoons) will be drawn for biomarker testing (at weeks 8, 16 and 24 only). * Blood (about 1 teaspoon) will be drawn for blood sugar tests. If you have a history of diabetes, you will need to fast for 8 hours before these blood sugar tests. * You will have imaging scans to check the status of the disease. Length of Study: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. This is an investigational study. Exemestane is FDA approved and commercially available for the treatment of metastatic breast cancer. Metformin is FDA approved and commercially available for the treatment of diabetes. Everolimus is FDA approved and commercially available to treat metastatic breast cancer, advanced kidney cancer in some patients and a certain type of brain tumor. The use of this drug combination is investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Postmenopausal overweight or obese women with a history of biopsy-proven hormone receptor-positive breast cancer and clinical evidence of metastatic disease. Overweight is defined as body mass index (BMI) of 25 - 29.9 kg/m2 while obese is defined as BMI \>/= 30 kg/m2. Postmenopausal status is defined by one of the following: a) no spontaneous menses for over 1 year, in women \>/=55 years; b) no spontaneous menses within the past 1 year in women \< 55 years with postmenopausal gonadotrophin levels (LH and FSH levels \> 40 IU/L) or postmenopausal estradiol levels (by local laboratory range); or c) bilateral oophorectomy.
•2. Prior hormonal therapy for metastatic breast cancer is allowed. Patients who develop progressive metastatic disease on a non-steroidal aromatase inhibitor are eligible. Patients who develop metastatic disease while receiving a non-steroidal aromatase inhibitor in the adjuvant setting are eligible.

Exclusion Criteria

•4. Prior tamoxifen, LH/RH agonist, anastrozole or letrozole therapy in the adjuvant and/or neoadjuvant settings is allowed. Prior adjuvant and/or neoadjuvant chemotherapy is allowed.
•5. Patients must have: \[1\] at least one lesion that can be accurately measured in at least one dimension \>/= 20 mm with conventional imaging techniques or \>/= 10 mm with spiral CT or MRI; or \[2\] bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease; the following will be considered disease progression among these patients: a) the appearance of one or more new lytic lesions in bone; b) the appearance of one or more new lesions outside of bone; c) unequivocal progression of existing bone lesions.
•6. Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of study medications.
•7. ECOG performance status \</= 2.
•8. Absolute neutrophil count (ANC) \>/= 1000/microliter, platelets \>/= 75,000/microliter, hemoglobin \>/= 8.5 gm/dL; creatinine clearance \>60 mg/dL; bilirubin \< 1.5 mg/dL (\</= 3 × ULN for patients known to have Gilbert Syndrome); ALT \<3 x upper limit of normal (or \</= 5 if hepatic metastases are present); alkaline phosphatase \< 3 x upper limit of normal; calcium \</= 11.0 mg/dL.
•9. Fasting serum cholesterol \</= 300 mg/dl or 7.75 mmol/L and fasting triglycerides \</= 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved.
•10. Bisphosphonate treatment is permitted for the management of bone loss and/or bone metastases.
•11. Patients must be competent to give informed consent and to state that they understand the investigational nature of the proposed treatment.
•1. HER2-overexpressing breast cancer (IHC 3+ staining or in situ hybridization positive).
•2. Diabetes mellitus on active treatment or hemoglobin A1C \>/= 6.5% or random plasma glucose \> 200 mg/dL in patients without known diabetes.
+17 more criteria

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

February 1, 2019

Completion Date

February 1, 2019

Last Updated

June 19, 2020

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Everolimus

DRUG

Exemestane

DRUG

Metformin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exemestane-RAD001-Metformin

Inclusion Criteria

Exclusion Criteria

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