Study on Olaparib for Treating Metastatic Breast Cancer
Sponsor: Beth Israel Deaconess Medical Center
ClinicalTrials ID:NCT03344965
This clinical trial is exploring the effectiveness of Olaparib, a PARP inhibitor, in treating metastatic breast cancer in patients with specific genetic mutations that affect DNA repair.
Patient Parameters
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Program Overview
This study is for patients with metastatic breast cancer, meaning the cancer has spread beyond the breast. It focuses on patients whose cancer cells have a genetic mutation that affects their ability to repair DNA. This makes the cancer potentially more sensitive to certain drugs, like Olaparib, which is being tested in this trial. Olaparib is a PARP inhibitor, a type of drug that may help treat breast cancer by targeting these mutations. The study will evaluate if Olaparib is effective for patients with mutations in genes related to BRCA1 and BRCA2, which are involved in DNA repair.
Description
This research is a Phase II clinical trial, which means it is testing the safety and effectiveness of Olaparib, an investigational drug, to see if it works for treating metastatic breast cancer. "Investigational" means that Olaparib is being studied for this specific use, and researchers are learning about its side effects and effectiveness.
DNA repair gene mutations are changes in genes that help fix damaged DNA. These mutations can be inherited or develop over time, and they can increase the risk of breast and ovarian cancer. Olaparib works by blocking an enzyme called PARP, which helps repair DNA. In people with BRCA1 or BRCA2 mutations, or similar gene defects, Olaparib may stop cancer cells from growing by preventing them from repairing their DNA.
The FDA has approved Olaparib for advanced ovarian cancer with BRCA mutations, but it is not yet approved for breast cancer. This study aims to find out if Olaparib can also be effective for breast cancer patients with specific genetic mutations.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed invasive breast cancer that has spread (stage IV) and is proven by biopsy or clear evidence from exams or scans.
- Must have a specific genetic mutation in DNA repair genes, but not in BRCA1 or BRCA2, unless it's a somatic mutation (developed in the tumor, not inherited).
- Must have at least one measurable tumor that can be tracked with scans.
- Must not have progressed on more than two chemotherapy treatments for metastatic cancer.
- Must be 18 years or older and in good health with a performance status of 0-1.
- Must have normal organ and bone marrow function based on recent tests.
- Must be willing to undergo a biopsy and provide informed consent.
- Women must not be pregnant and must use effective contraception during the study.
- Both men and women must agree to use contraception during and after the study.
Exclusion Criteria
- Previous treatment with a PARP inhibitor, including Olaparib.
- Inherited BRCA1 or BRCA2 mutation.
- Uncontrolled brain metastases or spinal cord compression.
- Major surgery within 2 weeks before starting the study.
- Use of certain medications that interact with Olaparib.
- Serious, uncontrolled medical conditions or infections.
- History of myelodysplastic syndrome or acute myeloid leukemia.
- Other cancers within the last 5 years, except for certain treated cancers.
- Pregnant or breastfeeding women.
- Known allergy to Olaparib or its ingredients.
- Active hepatitis B or C infection.
- Previous bone marrow transplant or certain blood transfusions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| University of California, San Francisco | 94143 | San Francisco | California |
| University of Chicago | 60637 | Chicago | Illinois |
| Indiana University | 46202 | Indianapolis | Indiana |
| Johns Hopkins University | 21218 | Baltimore | Maryland |
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Memorial Sloan Kettering Cancer Center Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Cancer Center Monmouth | 07748 | Middletown | New Jersey |
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