Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01627067
Status:
TERMINATED
Last Update Posted:
2020-06-19
First Post:
2012-06-21
Brief Title:
Exemestane-RAD001-Metformin
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Komen Foundation Funding Terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01164 | REGISTRY | NCI CTRP | None |