Ignite Creation Date:
2024-05-06 @ 9:00 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02871791
Status:
COMPLETED
Last Update Posted:
2022-08-29
First Post:
2016-06-29
Brief Title:
Palbociclib With Everolimus Exemestane In BC
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 1b2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive HR and HER2-negative
The names of the study interventions involved in this study are
Palbociclib
Everolimus
Exemestane
The names of the study interventions involved in this study are
Palbociclib
Everolimus
Exemestane
Detailed Description:
This is a Phase III clinical trial The Phase I portion of this clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies The Phase II portion of the study tests the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease Investigational means that the intervention is being studied
The FDA the US Food and Drug Administration has not approved the combination of Palbociclib Everolimus and Exemestane as a treatment for any disease
This is the first time that the combination of Palbociclib Everolimus and Exemestane will be given to humans
Palbociclib is a drug that may stop cancer cells from growing Palbociclib blocks activity of two closely related enzymes proteins that help chemical reactions occur in the body called Cyclin D Kinases 4 and 6 CDK 46 These proteins are part of a pathway or a sequence of steps which is known to regulate cell growth Laboratory testing has suggested Palbociclib may stop the growth of HR breast cancer
Everolimus is a type of drug called an mTORinhibitor that treats breast cancer by preventing the cells from multiplying by inhibiting the pathway or a sequence of steps known to regulate cell reproduction Everolimus also may stop the growth of cancer cells by decreasing blood supply to the cancer cells
Exemestane is an anti-hormone therapy that prevents breast cancer cell growth by blocking estrogen receptor stimulation Premenopausal women will also receive an injection drug called an LHRH luteinizing hormone-releasing hormone agonist to shut down ovary function It is standard of care for people with breast cancer specifically with HR breast cancer to take anti-hormone therapy
The combination of everolimus and exemestane is FDA approved to treat this type of breast cancer
The purpose of the Phase I portion of this research study is to determine a safe and tolerable dose of the combination of Palbociclib Everolimus and Exemestane for participants with ER-positive HER2-negative advanced breast cancer
The purpose of the Phase II portion of this research study is to determine whether the combination of Palbociclib Everolimus and Exemestane is an effective treatment for participants with ER-positive HER2-negative advanced breast cancer
The FDA the US Food and Drug Administration has not approved the combination of Palbociclib Everolimus and Exemestane as a treatment for any disease
This is the first time that the combination of Palbociclib Everolimus and Exemestane will be given to humans
Palbociclib is a drug that may stop cancer cells from growing Palbociclib blocks activity of two closely related enzymes proteins that help chemical reactions occur in the body called Cyclin D Kinases 4 and 6 CDK 46 These proteins are part of a pathway or a sequence of steps which is known to regulate cell growth Laboratory testing has suggested Palbociclib may stop the growth of HR breast cancer
Everolimus is a type of drug called an mTORinhibitor that treats breast cancer by preventing the cells from multiplying by inhibiting the pathway or a sequence of steps known to regulate cell reproduction Everolimus also may stop the growth of cancer cells by decreasing blood supply to the cancer cells
Exemestane is an anti-hormone therapy that prevents breast cancer cell growth by blocking estrogen receptor stimulation Premenopausal women will also receive an injection drug called an LHRH luteinizing hormone-releasing hormone agonist to shut down ovary function It is standard of care for people with breast cancer specifically with HR breast cancer to take anti-hormone therapy
The combination of everolimus and exemestane is FDA approved to treat this type of breast cancer
The purpose of the Phase I portion of this research study is to determine a safe and tolerable dose of the combination of Palbociclib Everolimus and Exemestane for participants with ER-positive HER2-negative advanced breast cancer
The purpose of the Phase II portion of this research study is to determine whether the combination of Palbociclib Everolimus and Exemestane is an effective treatment for participants with ER-positive HER2-negative advanced breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None