Study on Radiation Therapy With or Without Olaparib for Treating Inflammatory Breast Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03598257
This clinical trial is exploring whether adding the drug olaparib to radiation therapy can improve treatment outcomes for patients with inflammatory breast cancer. The study aims to determine if this combination is more effective than radiation therapy alone.
Patient Parameters
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Program Overview
This study is investigating if combining radiation therapy with a drug called olaparib can better treat inflammatory breast cancer compared to using radiation therapy alone. Radiation therapy uses high-energy x-rays to kill cancer cells, while olaparib is a targeted therapy that blocks an enzyme called PARP, which helps repair damaged DNA in cancer cells. By blocking PARP, olaparib may prevent cancer cells from repairing themselves, leading to their death. The study will compare the effectiveness of these treatments in preventing cancer from returning and improving survival rates.
Description
The main goal of this study is to see if adding olaparib to radiation therapy can help patients with inflammatory breast cancer live longer without the cancer coming back. The study will also look at how well the combination controls cancer in the chest area and improves overall survival.
Participants will be randomly assigned to one of two groups:
- Group 1: Will take olaparib pills twice a day starting the day before radiation therapy begins and continue throughout the 6-week radiation treatment, including weekends.
- Group 2: Will receive standard radiation therapy alone for 6 weeks.
All participants will have blood samples taken during the study to help researchers understand the treatment's effects.
After finishing the treatment, participants will have follow-up visits within 5 weeks, then every 3 months for 3 years, and every 6 months for up to 8 years to monitor their health and any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Must have inflammatory breast cancer without cancer spread to distant parts of the body.
- Must have completed chemotherapy before surgery, including at least 4 cycles of specific drugs.
- Must have had surgery to remove the breast and lymph nodes, with no remaining cancer.
- Can have additional chemotherapy after surgery if needed.
- Must not have had radiation therapy to the chest area before.
- Must not be planning to take other investigational drugs during the study.
- Must not have allergies to olaparib or its ingredients.
- Must not have unresolved side effects from previous treatments.
- Must not take certain medications that interact with olaparib.
- Must not receive live vaccines during the study.
- Must be 18 years or older.
- Must have good overall health and specific blood counts.
- Must not have other serious health conditions or recent major surgeries.
- Women must not be pregnant or breastfeeding and must use effective birth control during and after the study.
- Must be able to swallow pills and not have digestive issues affecting medication absorption.
- Must not have certain heart conditions or blood disorders.
- Must agree to provide blood samples for future research.
- Must be able to complete quality of life questionnaires in English.
- Must sign an informed consent form to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| University of Arizona Cancer Center-Orange Grove Campus | 85704 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
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