Title: A phase II study of niraparib, dostarlimab and radiotherapy in metastatic, PD-L1 negative or immunotherapy-refractory triple-negative breast cancer (NADiR)

Principal Investigator: Alice Ho, MD, of Massachusetts General Hospital in Boston

Description: Researchers are conducting a phase 2 trial to investigate the safety and efficacy of niraparib in combination with dostarlimab and radiotherapy in patients with metastatic triple-negative breast cancer (TNBC).


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In each 3-week treatment cycle, patients will receive niraparib once daily. They will also receive dostarlimab once every 3 weeks for 4 cycles, then once every 6 weeks starting with cycle 5. Radiotherapy will be administered on the first 3 days of cycle 1.

Participants will receive the study treatment for up to 2 years or until disease progression. 

The primary outcome is overall response rate. Secondary outcomes include treatment-related adverse events, overall survival, progression-free survival, and change in quality of life.

To be eligible for this study, patients must be 18 years of age or older and have a histologically- or cytologically-confirmed diagnosis of TNBC. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Massachusetts General Hospital in collaboration with Johns Hopkins University, University of North Carolina, and University of Pennsylvania.

Reference

ClinicalTrials.gov. Radiation, immunotherapy and PARP inhibitor in triple negative breast cancer (NADiR). NCT04837209. Accessed September 19, 2022.