Niraparib + Radiotherapy for Triple Negative Breast Cancer
(UNITY Trial)
Trial Summary
Will I have to stop taking my current medications?
You will need to stop taking any cytotoxic chemotherapy, immunotherapy, and biologic therapy at least 2 weeks before starting the trial. However, you can continue taking corticosteroids if your dose has been stable for at least 4 weeks before starting the trial.
What data supports the effectiveness of the drug Niraparib for treating triple-negative breast cancer?
Is the combination of Niraparib and Radiotherapy safe for humans?
How does the drug Niraparib combined with radiotherapy differ from other treatments for triple-negative breast cancer?
Niraparib, a PARP inhibitor, is unique in its combination with radiotherapy for treating triple-negative breast cancer, as it targets DNA repair mechanisms, potentially enhancing the effectiveness of radiation. This approach is novel compared to standard treatments, which often do not combine these specific therapies.136910
What is the purpose of this trial?
This research study involves Niraparib as a possible treatment for triple negative breast cancer.
Research Team
Alice Ho, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for adults with non-metastatic triple negative breast cancer who've had surgery and are planning postoperative radiation therapy. They must have some remaining invasive disease, not be pregnant or breastfeeding, agree to contraception use, and have good organ function. Exclusions include prior PARP inhibitor treatment, certain small tumors, significant other diseases or unresolved toxicities from past treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Niraparib is administered orally on a daily basis, concurrently with radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Niraparib
- Radiation Therapy
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Tesaro, Inc.
Industry Sponsor