Radiation Therapy + Olaparib for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking strong or moderate CYP3A inhibitors at least 2 weeks before starting olaparib and strong or moderate CYP3A inducers at least 5 weeks before. You also cannot take any additional anti-cancer therapy during the trial.
What data supports the effectiveness of the treatment Radiation Therapy + Olaparib for Breast Cancer?
Research shows that radiotherapy, including intraoperative radiotherapy (IORT), is effective in controlling local and regional breast cancer and improving quality of life by relieving pain from metastases. Additionally, IORT has been associated with favorable outcomes in early-stage breast cancer, suggesting its potential effectiveness when combined with other treatments like Olaparib.12345
Is the combination of radiation therapy and olaparib generally safe for humans?
Radiation therapy, including advanced techniques like image-guided radiotherapy (IGRT), is generally considered safe and is commonly used in clinical practice, though it can have some side effects. However, there is limited long-term safety data on using new targeted agents like olaparib concurrently with radiation therapy for breast cancer.678910
How is the treatment of Radiation Therapy + Olaparib unique for breast cancer?
This treatment combines radiation therapy, which targets and kills cancer cells in the breast, with Olaparib, a drug that blocks an enzyme (PARP) involved in repairing damaged DNA in cancer cells, making it harder for them to survive. This combination is unique because it uses both a targeted drug and radiation to potentially enhance the effectiveness of treatment for breast cancer.1361112
What is the purpose of this trial?
This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
Research Team
Reshma Jagsi
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
This trial is for adults with inflammatory breast cancer without distant metastases who have completed neoadjuvant chemotherapy and mastectomy. They must not have had prior radiation to the chest or certain drug treatments during the study, agree to contraception if of childbearing potential, and cannot be breastfeeding. Participants need proper organ function, no uncontrolled diseases or recent major surgeries, and can't be on strong CYP3A inhibitors/inducers.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive olaparib and/or radiation therapy 5 days per week for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olaparib
- Radiation Therapy
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor