Radiation Therapy + Olaparib for Breast Cancer

Recruiting at 262 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

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

I will not get live vaccines while on olaparib and for 30 days after.

I am not planning to receive any other cancer treatments while on the study.

Your alkaline phosphatase levels should be within a certain range, not too high.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)
• Radiation Therapy (Radiation)

Trial Overview The trial is testing whether adding Olaparib (a PARP inhibitor that prevents cancer cells from repairing DNA damage) to standard radiation therapy improves outcomes in patients with inflammatory breast cancer compared to radiation alone. Patients are randomly assigned to one of these two treatment options.

Participant Groups

Group I: Group I (olaparib, radiation therapy) Experimental Treatment 4 Interventions

Patients receive olaparib PO BID the day before standard RT commences (Day 0) and throughout the RT course until the last day of RT administration. Olaparib is also continued on weekends (routine days without RT) throughout the RT course. Patients undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Group II: Group II (radiation therapy) Active Control 3 Interventions

Patients undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+