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Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

NCT04584255 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-13

No results posted yet for this study

Summary

This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations.

The names of the study drugs involved in this study are:

* Niraparib (Zejula)
* Dostarlimab

Conditions

  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Breast Cancer
  • HER2-negative Breast Cancer
  • Germline BRCA1 Gene Mutation
  • Germline BRCA2 Gene Mutation
  • Deleterious PALB2 Gene Mutation

Interventions

DRUG

Niraparib

Predetermined dosage PO Daily

DRUG

Dostarlimab

Predetermined Dosage, IV,q3 weeks

Sponsors & Collaborators

Principal Investigators

  • Erica L. Mayer, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2025-07-01
Completion
2029-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584255 on ClinicalTrials.gov