Treating Early-Stage HER2-Negative Breast Cancer with a PARP Inhibitor (Niraparib) and Immunotherapy (Dostarlimab) in People with a BRCA or PALB2 Mutation identifier:
NCT04584255 (

Treatment before surgery for people with early-stage breast cancer & a BRCA1, BRCA2 or PALB2 mutation

Study Contact Information:

For additional information, please contact: Erica L Mayer, MD MPH by phone: 617-632-3800 or by email at: [email protected]  

About the Study

This study will look at how well the drugs Niraparib (a PARP inhibitor) and Dostarlimab (an immunotherapy) treat early-stage breast cancer in people with an inherited BRCA1, BRCA2 or PALB2 mutation. 

What the Study Entails

The study will have three different groups of participants (Group A, Group B and Group C). Participants in each group will receive both study drugs. The timing of the drugs differs by group. The study is open label, which means that all participants will know which group they are assigned to.

This study is open to participants with triple-negative breast cancer and participants with ER-positive breast cancer. Participants with triple negative breast cancer will be randomized (randomly assigned) to one of two treatment arms (Group A or Group B).

All participants with ER-positive breast cancer will be placed into Group C.

Participants will receive treatment for 18 weeks. After 18 weeks, participants will be evaluated to determine if they are a candidate for surgery or if they will require additional treatment.

Study Sites


Boston, MA

This Study is Open To:

To participate, people must have the following diagnosis:

This Study is Not Open To:

People with the following may not participate:


FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.