This trial aims to test the effectiveness of adding olaparib (Lynparza) to radiotherapy for inflammatory breast cancer. The main outcome measured will be how long the patients survive without the disease coming back in its invasive form. The study is being conducted in the United States.
The details
Inflammatory breast cancer can be very hard to treat. It often needs many types of treatment, such a chemotherapy, removing the breast, and radiation therapy. Olaparib is a new medication for cancer treatment. It works by stopping the tumor cells from growing. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
This trial aims to test if adding olaparib to radiotherapy for inflammatory breast cancer increases survival. The main outcome measured will be how long the patients survive without the disease coming back in its invasive form.
Who are they looking for?
The study is recruiting 300 patients that have had chemotherapy followed by breast surgery. Patients must not have had radiation therapy to the chest before. This must be the only trial the patient is on. The patient must not be receiving any other type of therapy or planning to do any other type of therapy for 12 weeks. Patients must have adequate blood cell counts, kidney, and liver function tests. Patients can have had another cancer previously, as long as they have been disease-free for five years.
Female patients must not be planning on getting pregnant and must use contraception. Patients must not have a history of heart problems. Patients must not have an infection or have had major surgery in the two weeks before the study starts.
How will it work
There will be two groups in this study. One group will recieve radiation therapy 5 days a week for 6 weeks. The second group will recieve radiation therapy 5 days a week for 6 weeks and will also be treated with olaparib. Olaparib tablets will be given twice a day from the day before starting radiotherapy every day until the end of radiotherapy. After the end of the treatment, participants are followed up within 5 weeks, then every 3 months until 3 years, and then every 6 months for up to 8 years.
The main outcomes measured will be survival without cancer returning and overall survival.
