21 Participants Needed

Niraparib + Radiotherapy for Triple Negative Breast Cancer

(UNITY Trial)

Recruiting at 1 trial location
Alice Ho, MD profile photo
Overseen ByAlice Ho, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that Niraparib, a PARP inhibitor, has been explored in mouse models of triple-negative breast cancer with BRCA mutations, indicating potential effectiveness in this context.12345

Is the combination of Niraparib and Radiotherapy safe for humans?

Niraparib has been studied for safety in patients with ovarian cancer, where nearly all patients experienced some side effects, with serious side effects in 51-74% of cases. Common side effects included blood-related issues like low platelet counts and anemia, as well as digestive problems.13678

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

ABR

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

I still have cancer after chemotherapy, or my tumor is at least 1.0 cm without chemotherapy.
I can swallow and keep down pills.
Participant must agree not to breastfeed during the study or for 30 days after the last dose of study treatment
See 12 more

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.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Niraparib is administered orally on a daily basis, concurrently with radiation therapy

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • Niraparib
  • Radiation Therapy
Trial Overview 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.
Participant Groups
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:

🇪🇺
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
🇺🇸
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
🇨🇦
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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Tesaro, Inc.

Industry Sponsor

Trials
57
Recruited
10,600+

Findings from Research

The combination of olaparib, a PARP inhibitor, and paclitaxel showed a promising response rate of 37% in patients with metastatic triple-negative breast cancer, indicating potential efficacy despite safety concerns.
Neutropenia was a significant side effect, with high rates observed in both treatment cohorts, leading to dose modifications and the need for prophylactic granulocyte-colony stimulating factor, highlighting the need for careful management of side effects in future studies.
Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer.Dent, RA., Lindeman, GJ., Clemons, M., et al.[2021]
Currently, cytotoxic chemotherapy is the only proven systemic treatment for triple-negative breast cancer, which lacks key hormone receptors and HER2 overexpression.
The review highlights emerging management strategies, including targeted agents, biologics, and immunotherapy, that may significantly improve treatment options for triple-negative breast cancer in the near future.
Practical Approach to Triple-Negative Breast Cancer.Gadi, VK., Davidson, NE.[2018]
Niraparib, a PARP inhibitor, significantly increased median survival and reduced tumor burden in a specific BRCA-mutant TNBC mouse model (MDA-MB-436), demonstrating its potential efficacy against brain metastases of triple-negative breast cancer.
The study found that combining RAD51 inhibition with PARP inhibition could enhance the sensitivity of various TNBC cell lines to treatment, suggesting a promising strategy for improving therapeutic outcomes in this challenging cancer type.
Efficacy and pharmacodynamics of niraparib in BRCA-mutant and wild-type intracranial triple-negative breast cancer murine models.Sambade, MJ., Van Swearingen, AED., McClure, MB., et al.[2022]

References

Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer. [2021]
Practical Approach to Triple-Negative Breast Cancer. [2018]
Efficacy and pharmacodynamics of niraparib in BRCA-mutant and wild-type intracranial triple-negative breast cancer murine models. [2022]
Optimal strategies for the treatment of metastatic triple-negative breast cancer with currently approved agents. [2020]
Advances in the systemic treatment of triple-negative breast cancer. [2023]
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]
Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. [2021]
Safety and management of niraparib monotherapy in ovarian cancer clinical trials. [2023]
Low-Dose and Long-Term Olaparib Treatment Sensitizes MDA-MB-231 and SUM1315 Triple-Negative Breast Cancers Spheroids to Fractioned Radiotherapy. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Combination of Olaparib with radiotherapy for triple-negative breast cancers: One-year toxicity report of the RADIOPARP Phase I trial. [2021]
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