Radiation + Pembrolizumab + Olaparib for Breast Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).
Do I need to stop my current medications to join the trial?
The trial requires a washout period (time without taking certain medications) of at least 2 weeks for all anti-cancer agents and certain other medications before starting the study treatment. If you are taking strong or moderate CYP3A inhibitors or inducers, specific washout periods of 2 to 5 weeks are required. Please consult with the trial team to discuss your specific medications.
What data supports the effectiveness of the treatment Radiation + Pembrolizumab + Olaparib for Breast Cancer?
Research suggests that combining radiation with pembrolizumab (an immunotherapy drug) can enhance immune responses against cancer, as seen in studies with breast cancer and other types like lung cancer. Additionally, early clinical trials have shown promising results when combining radiation and immunotherapy in breast cancer, indicating potential benefits of this treatment approach.12345
Is the combination of radiation, pembrolizumab, and olaparib safe for humans?
How is the treatment of Radiation + Pembrolizumab + Olaparib for breast cancer different from other treatments?
This treatment is unique because it combines radiation therapy, which can enhance the immune response against tumors, with pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, and olaparib, a drug that targets cancer cell DNA repair mechanisms. This combination aims to improve both local and systemic cancer control by leveraging different mechanisms to fight breast cancer.12345
Research Team
Atif Khan, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for women at least 18 years old with metastatic or recurrent triple-negative or hormone-receptor positive/Her2 negative breast cancer. Participants must not be pregnant, breastfeeding, and should follow contraceptive guidance. They need to have stable organ function and performance status (ECOG) of 0-1. Those with HIV, active TB or hepatitis, severe allergies to study drugs, certain previous treatments or conditions that could affect the study's outcome are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab with or without olaparib in combination with standard radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olaparib
- Pembrolizumab
- Radiation
Radiation is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor