Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03344965
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2017-10-31
Brief Title:
Olaparib in Metastatic Breast Cancer
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients with Germline or Somatic Mutations in DNA Repair Genes Olaparib Expanded
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 for patients with metastatic breast cancer
Metastatic means that the cancer has spread beyond the breast In addition through genetic testing of the blood or tumor an altered gene has been found that suggests the tumor may not be able to repair its genetic material DNA when it becomes damaged
This aspect of the cancer may cause it to be more sensitive - that is more effectively killed by certain types of drugs such as the study agent being evaluated in this trial Olaparib
Olaparib is a type of drug known as a PARP inhibitor Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments Information from those other research studies suggests that this drug may help to treat metastatic breast cancer
This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA This mutation may have been inherited from a parent or may have developed only in the tumor
This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor but not inherited
Metastatic means that the cancer has spread beyond the breast In addition through genetic testing of the blood or tumor an altered gene has been found that suggests the tumor may not be able to repair its genetic material DNA when it becomes damaged
This aspect of the cancer may cause it to be more sensitive - that is more effectively killed by certain types of drugs such as the study agent being evaluated in this trial Olaparib
Olaparib is a type of drug known as a PARP inhibitor Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments Information from those other research studies suggests that this drug may help to treat metastatic breast cancer
This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA This mutation may have been inherited from a parent or may have developed only in the tumor
This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor but not inherited
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer Investigational means that the study drug Olaparib is being studied for use in this setting and the research doctors are trying to learn more about it-the side effects it may cause and if the drug is effective in treating this type of cancer
What is a DNA repair gene mutation
-- In order to survive all cells even cancer cells must be able to repair their genetic material DNA when it gets damaged A mutation is an alteration or change in a gene- either inherited from a parent or acquired over time- that prevents the gene from working properly Faulty genes or genes that carry a mutation have been linked to increased risk of hereditary breast and ovarian cancer
What is Olaparib
Olaparib is a drug that may stop cancer cells from growing Olaparib is a PARP inhibitor which means that it blocks an enzyme proteins that help chemical reactions in the body occur in cells called PARP PARP helps repair DNA when it becomes damaged It has been shown that the tumors in individuals who have inherited or acquired a mutation in the BRCA1 or BRCA2 genes are often sensitive to killing by PARP inhibitors
In normal cells and many other tumors repair of damage to the DNA requires pathways of genes that work with BRCA1 and BRCA2 Therefore when a drug that inhibits PARP from working is given to people with a BRCA mutation or a defect in another gene that works with BRCA1 and BRCA2 both ways of repairing damaged DNA no longer work The combined effect of knocking out both DNA repair mechanisms is so severe that the cancer cells could die This might stop the growth of type of breast cancer but this is not known
The FDA US Food and Drug Administration has approved Olaparib for use in advanced ovarian cancer with a BRCA1 or BRCA2 mutation Olaparib is not approved for breast cancer
What is a DNA repair gene mutation
-- In order to survive all cells even cancer cells must be able to repair their genetic material DNA when it gets damaged A mutation is an alteration or change in a gene- either inherited from a parent or acquired over time- that prevents the gene from working properly Faulty genes or genes that carry a mutation have been linked to increased risk of hereditary breast and ovarian cancer
What is Olaparib
Olaparib is a drug that may stop cancer cells from growing Olaparib is a PARP inhibitor which means that it blocks an enzyme proteins that help chemical reactions in the body occur in cells called PARP PARP helps repair DNA when it becomes damaged It has been shown that the tumors in individuals who have inherited or acquired a mutation in the BRCA1 or BRCA2 genes are often sensitive to killing by PARP inhibitors
In normal cells and many other tumors repair of damage to the DNA requires pathways of genes that work with BRCA1 and BRCA2 Therefore when a drug that inhibits PARP from working is given to people with a BRCA mutation or a defect in another gene that works with BRCA1 and BRCA2 both ways of repairing damaged DNA no longer work The combined effect of knocking out both DNA repair mechanisms is so severe that the cancer cells could die This might stop the growth of type of breast cancer but this is not known
The FDA US Food and Drug Administration has approved Olaparib for use in advanced ovarian cancer with a BRCA1 or BRCA2 mutation Olaparib is not approved for breast cancer
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?:
True
Is an FDA AA801 Violation?:
None