~3 spots leftby Jan 2026

Niraparib + Radiotherapy for Triple Negative Breast Cancer (UNITY Trial)

Palo Alto (17 mi)
ABR
Overseen byAlice Ho, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Massachusetts General Hospital
No Placebo Group
Breakthrough Therapy
Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This research study involves Niraparib as a possible treatment for triple negative breast cancer.

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

I still have cancer after chemotherapy, or my tumor is at least 1.0 cm without chemotherapy.
I can swallow and keep down pills.
My breast cancer is triple-negative and has not spread to other parts of my body.
I had surgery to remove my breast cancer and check the lymph nodes.
I agree to use birth control from the start of the study until 90 days after it ends.
I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

I have not had any other cancer in the last 5 years.
I have a history of MDS or AML.
I have not had cancer treatments for at least 2 weeks and any side effects have gone.
I have scleroderma or systemic lupus erythematosus.
I have no lasting side effects from previous treatments.
I have never had radiation therapy on the same side breast or nearby lymph nodes.
I have a known p53 gene mutation.
I weigh less than 77kg or my platelet count is below 150,000.
My breast cancer is small, has not spread to lymph nodes, and is triple negative. I had surgery after chemotherapy.
I have severe anemia, low white blood cell count, or low platelet count from my last chemo.
I have never taken PARP inhibitors before.
I had major surgery less than 3 weeks ago but have recovered from it.
I have brain or spinal cord cancer spread.

Treatment Details

The study tests Niraparib given alongside standard postoperative radiation therapy in patients with triple negative breast cancer. It aims to see if this combination can improve outcomes compared to radiation alone.
1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment2 Interventions
* Niraparib will be administered orally on a daily basis * Radiation Therapy will be administered concurrently with Niraparib
Niraparib is already approved in European Union, United States, Canada for the following indications:
πŸ‡ͺπŸ‡Ί Approved in European Union as Zejula for:
  • 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
πŸ‡ΊπŸ‡Έ Approved in United States as Zejula for:
  • 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
πŸ‡¨πŸ‡¦ Approved in Canada as Zejula for:
  • 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

Research locations nearbySelect from list below to view details:
Dana Farber Cancer Institute/Brigham and Women's HospitalBoston, MA
Massachusetts General Hospital Cancer CenterBoston, MA
Loading ...

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
Tesaro, Inc.Industry Sponsor

References