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 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.
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 (U.S. 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.
Metastatic Breast Cancer, Invasive Breast Cancer, Somatic Mutation Breast Cancer (BRCA1), Somatic Mutation Breast Cancer (BRCA2), CHEK2 Gene Mutation, ATM Gene Mutation, PALB2 Gene Mutation, RAD51 Gene Mutation, BRIP1 Gene Mutation, NBN Gene Mutation
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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