Study on Radiation, Immunotherapy, and PARP Inhibitor for Treating Metastatic Triple Negative Breast Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04837209

Provider View

This clinical trial is testing a new combination of treatments, including the drugs Dostarlimab and Niraparib along with Radiation Therapy, to see if they are safe and effective for patients with metastatic triple negative breast cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining the drugs Dostarlimab and Niraparib with Radiation Therapy can safely and effectively treat metastatic triple negative breast cancer. Dostarlimab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. Niraparib is a PARP inhibitor that prevents cancer cells from repairing their DNA, which may help kill them. Radiation Therapy is a standard treatment that targets and destroys cancer cells. The study will involve screening for eligibility, receiving the study treatments, and follow-up visits. Participants will receive the treatments for up to 2 years or until their cancer worsens, and will be followed for up to 5 years. About 32 people are expected to participate in this study.

Description

This study is an open-label, phase II trial to evaluate the safety and effectiveness of combining Niraparib, Dostarlimab, and Radiation Therapy for treating metastatic triple negative breast cancer. Niraparib is a PARP inhibitor that blocks cancer cells from repairing their DNA, potentially leading to their death. Dostarlimab is an immunotherapy drug that helps the immune system attack cancer cells by blocking a protein called PD-1. Radiation Therapy is a standard treatment that stops tumor growth and can stimulate the immune system to destroy cancer cells. The study involves screening for eligibility, receiving the study treatments, and follow-up visits. Participants will receive the treatments for up to 2 years or until their cancer worsens, and will be followed for up to 5 years. Approximately 32 people will take part in this study. The FDA has not approved Niraparib for metastatic triple negative breast cancer, but it is approved for other uses. Dostarlimab is not approved by the FDA for any disease.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of triple negative breast cancer (TNBC) that is metastatic or has returned.
  • Have previously tried an immune-checkpoint inhibitor and/or have PDL1-negative status.
  • Have received no more than 2 prior lines of systemic therapy for inoperable or metastatic disease.
  • Radiation therapy is needed for local control or symptom relief.
  • Have at least one tumor suitable for radiation therapy and one measurable metastasis that will not receive radiation.
  • Have available tumor tissue for testing or be willing to provide a new biopsy.
  • Have adequate organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 180 days after the last treatment.
  • Men must agree to use contraception and not donate sperm during the study and for 90 days after the last treatment.
  • Must agree not to breastfeed or donate blood during the study and for a specified period after the last treatment.
  • Must be able to swallow and retain oral medications.
  • Must understand and agree to sign an informed consent document.

Exclusion Criteria

  • Have a known BRCA mutation.
  • Have active brain metastases or leptomeningeal disease.
  • Have another cancer that required treatment in the last 2 years, except for certain skin or cervical cancers.
  • Have received both a PARP inhibitor and immune checkpoint inhibitor before.
  • Have received more than 2 lines of chemotherapy for metastatic disease.
  • Have allergies to Niraparib or Dostarlimab.
  • Have participated in another study with an investigational agent within 4 weeks.
  • Have not recovered from side effects of previous treatments.
  • Have had major surgery within 3 weeks before starting the study.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have a diagnosis of immunodeficiency or are receiving systemic steroids or immunosuppressive therapy.
  • Have a history of severe lung disease or pneumonitis.
  • Have an active infection requiring treatment.
  • Have any condition that might interfere with the study or is not in the patient's best interest.
  • Have psychiatric or substance abuse disorders that would interfere with the study.
  • Have a serious, uncontrolled medical disorder.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have a history of myelodysplastic syndrome or acute myeloid leukemia.
  • Have active HIV, Hepatitis B, or Hepatitis C infections.
  • Have active tuberculosis.
  • Have received a live vaccine within 14 days before starting the study.
  • Have received a blood transfusion or colony stimulating factors within 4 weeks before starting the study.
  • Have had severe blood cell count issues from previous chemotherapy.

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