Niraparib + Radiotherapy for Triple Negative Breast Cancer
(UNITY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the use of Niraparib, an oral medication, combined with radiation therapy to determine its effectiveness in treating triple negative breast cancer (a type of breast cancer lacking three common receptors). The goal is to assess whether this combination can manage or reduce the cancer. The trial seeks participants who have undergone surgery for triple negative breast cancer but still have some invasive disease. Participants should plan to receive radiation therapy and must stop other cancer treatments before starting this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.
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.
Is there any evidence suggesting that Niraparib and Radiation Therapy are likely to be safe?
Studies have shown that Niraparib is generally well-tolerated by patients with various types of cancer, including breast cancer. In past research, patients taking Niraparib for breast cancer, including those with triple-negative breast cancer, experienced some side effects, which were mostly manageable. Common side effects included tiredness, nausea, and low blood cell counts, while serious problems were uncommon.
Research also shows that combining Niraparib with other treatments, such as pembrolizumab, has yielded promising results in fighting cancer while maintaining safety. Since this trial is in the early phase, it primarily focuses on ensuring the treatment's safety for participants. Niraparib is already FDA-approved for other conditions, suggesting some confidence in its safety. However, each study is unique, so monitoring for any new findings as the trial progresses is important.12345Why do researchers think this study treatment might be promising for triple negative breast cancer?
Unlike the standard treatments for triple-negative breast cancer, which typically involve chemotherapy, Niraparib is a PARP inhibitor that targets the DNA repair process in cancer cells, making it harder for them to survive. This mechanism of action is particularly exciting because it has the potential to enhance the effectiveness of concurrent radiation therapy, a common component in cancer treatment. Researchers are hopeful that combining Niraparib with radiation could lead to better outcomes by specifically attacking cancer cells while sparing healthy ones, potentially reducing side effects and improving patient quality of life.
What evidence suggests that Niraparib combined with radiotherapy could be an effective treatment for triple negative breast cancer?
Research has shown that Niraparib, a drug tested in this trial for triple negative breast cancer, yields promising results. In one study, patients who took Niraparib with pembrolizumab showed a strong reduction in tumor size, including those with advanced cancer. Another study found that after two rounds of Niraparib, about 90.5% of patients experienced at least a 30% reduction in tumor size. These findings suggest that Niraparib could help reduce tumors in patients with triple negative breast cancer. In this trial, Niraparib will be administered alongside Radiation Therapy to evaluate its effectiveness.23467
Who Is on the Research Team?
Alice Ho, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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