Study on Niraparib and Dostarlimab for BRCA Mutated Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04584255

Provider View

This clinical trial is testing a combination of two drugs, Niraparib and Dostarlimab, to see if they can effectively treat breast cancer in patients with specific genetic mutations (BRCA and PALB2) before surgery.

Patient Parameters

Program Overview

This study is focused on treating breast cancer in patients with BRCA and PALB2 mutations using two drugs, Niraparib and Dostarlimab, before surgery. The aim is to see if this combination can help control the cancer. Participants will receive treatment for 18 weeks and will be evaluated to see if they are ready for surgery or need further treatment. The study involves about 62 participants and is a Phase II trial, which means it is testing the safety and effectiveness of these drugs for this specific type of cancer. Currently, these drugs are not approved by the FDA for breast cancer, but Niraparib is approved for ovarian cancer with BRCA mutations.

Description

In this study, participants will undergo screening to ensure they are eligible, followed by treatment and regular evaluations. The treatment lasts for 18 weeks, after which participants will be assessed for surgery or additional treatment. Participants with triple negative breast cancer will be randomly assigned to one of two groups: one receiving both Niraparib and Dostarlimab for 18 weeks, and the other receiving Niraparib alone for 3 weeks, followed by both drugs for 15 weeks. Those with estrogen receptor positive breast cancer will receive both drugs for 18 weeks without randomization. The study aims to understand the safety and effectiveness of these drugs in treating breast cancer with specific genetic mutations. Participants will have regular lab tests, imaging, and biopsies to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed invasive breast cancer (Stage I to III) with a tumor size of at least 1.0 cm.
  • Must have a BRCA1, BRCA2, or PALB2 mutation.
  • Must be 18 years or older.
  • Must have good organ and bone marrow function.
  • Must agree to use effective contraception during the study and for a specified period after.
  • Must be able to swallow oral medication.
  • Must be willing to undergo required biopsies and follow study procedures.

Exclusion Criteria

  • Have Stage IV breast cancer.
  • Have received prior treatment for the current breast cancer.
  • Have a history of certain other cancers unless disease-free for a specified period.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
  • Have a history of lung disease or recent major surgery.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Have a known allergy to the study drugs or similar compounds.

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