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Monoclonal Antibodies

Niraparib + Dostarlimab for Breast Cancer

Phase 2

Recruiting

Led By Erica L. Mayer, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have documentation of estrogen receptor (ER) and progesterone receptor (PR) testing by IHC according to local institutional guidelines in a CLIA-approved setting. Central confirmation of ER/PR status is not required. All tumors must be HER2 negative.

Arm C: Target lesion must be ER and/or PR positive (>10% staining) by local review.

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib, dostarlimab, or their excipients

Prior treatment for the current breast cancer, including prior chemotherapy, immune therapy, hormonal therapy, radiation, or investigational therapy for this diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well a combination of two drugs works in treating patients with breast cancer that has spread to other parts of the body and have certain genetic mutations

Who is the study for?

This trial is for adults with Stage I to III breast cancer who have a BRCA1, BRCA2, or PALB2 mutation. They must be able to take oral medication and have no history of treatment for their current breast cancer. Individuals with severe health issues like heart disease, uncontrolled infections, or recent major surgery are not eligible.

What is being tested?

The study tests pre-operative therapy using Niraparib (Zejula) and Dostarlimab in individuals with specific genetic mutations linked to breast cancer. It aims to see how well these drugs work before any surgical intervention.

What are the potential side effects?

Potential side effects may include allergic reactions related to the study drugs' components, as well as general risks associated with taking medications such as fatigue, digestive issues, and possible impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is ER and PR positive and HER2 negative, tested in a certified lab.

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My cancer is estrogen or progesterone receptor positive.

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My cancer's estrogen and progesterone receptor status has been tested.

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I have a harmful genetic change in BRCA1, BRCA2, or PALB2.

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I can swallow and keep down pills.

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My breast cancer is confirmed and the tumor is at least 1.5 cm big.

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My cancer is not driven by estrogen or progesterone.

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My breast cancer is confirmed, not inflammatory, and the largest tumor is at least 1.5 cm.

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My tumor is HER2-negative as per the tests.

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I am fully active or can carry out light work.

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I am having a lumpectomy and can safely receive radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to medications similar to niraparib or dostarlimab.

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I have received treatments like chemotherapy or radiation for my current breast cancer.

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I have had interstitial lung disease or pneumonitis.

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I have a history of MDS or AML.

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I have not had a blood transfusion in the last 4 weeks.

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I have had a biopsy or lymph node removal before starting the study treatment.

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My breast cancer is at stage IV.

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I have not had major surgery in the last 3 weeks.

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I do not have any severe illnesses that are not under control.

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I have not taken steroids or immunosuppressants in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inverse PCR

Tumor-infiltrating lymphocytes (TILs)

Secondary study objectives

Changes in TILs

Number of Participants With Treatment-Related NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Rate of Residual Cancer Burden (RCB) 0/1 response

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C ER+/HER2-Experimental Treatment2 Interventions

exploratory cohort of estrogen receptor (ER) positive HER2-negative participants will be enrolled to Arm C. * Niraparib Daily beginning with week 1, day 1 * Dostarlimab Once every three weeks beginning with week 1, day 1

Group II: Arm B TNBCExperimental Treatment2 Interventions

Participants will be randomized 1:1 to treatment with the combination (Arm B) * 3-week lead-in of niraparib monotherapy followed by treatment with the combination * Niraparib Daily beginning with week 1, day 1 * Dostarlimab Once every three weeks beginning with week 4, day 1

Group III: Arm A Triple Negative Breast Cancer (TNBC)Experimental Treatment2 Interventions

Participants will be randomized 1:1 to treatment with the combination (Arm A) * Niraparib-Daily beginning with week 1, day 1 * Dostarlimab-Once every three weeks beginning with week 1, day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

Dostarlimab

2020

Completed Phase 3

~1760