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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.
Adequate organ and bone marrow function as defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 organs and bone marrow are functioning well.
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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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I am 18 years old or older.
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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.
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I can swallow and keep down pills.
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I agree to have two biopsies: one now and another after 3 weeks of treatment.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inverse PCR
Tumor-infiltrating lymphocytes (TILs)
Secondary outcome measures
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

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
~1540
Dostarlimab
2020
Completed Phase 2
~1000

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,681 Total Patients Enrolled
141 Trials studying Breast Cancer
22,555 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,748 Previous Clinical Trials
8,067,450 Total Patients Enrolled
31 Trials studying Breast Cancer
2,326,242 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,295 Total Patients Enrolled
12 Trials studying Breast Cancer
1,513 Patients Enrolled for Breast Cancer

Media Library

Dostarlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04584255 — Phase 2
Breast Cancer Research Study Groups: Arm A Triple Negative Breast Cancer (TNBC), Arm C ER+/HER2-, Arm B TNBC
Breast Cancer Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT04584255 — Phase 2
Dostarlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04584255 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide a tally of how many different hospitals are managing this trial?

"At the moment, this clinical trial is recruiting patients from 7 different sites. These locations include Baltimore, Rochester and Boston among others. If you enroll in the study, it would be beneficial to select a location close to minimize travel requirements."

Answered by AI

Could you provide more information on Niraparib research?

"Niraparib is being studied in 112 different active clinical trials, 14 of which are Phase 3. The majority of Niraparib studies are based out of Washington D.C., however there are 3147 locations worldwide where patients can receive this treatment as part of a clinical trial."

Answered by AI

What are the main therapeutic benefits of Niraparib?

"Niraparib is most commonly used to treat primary peritoneal cancer, but it can also be taken to treat advanced mismatch repair-deficient (dmmr) endometrial cancer, disease that has progressed during or following platinum-containing chemotherapy, and fallopian tubes cancer."

Answered by AI

Is this clinical trial still enrolling new patients?

"Yes, the trial is recruiting patients as of today. According to the information on clinicaltrials.gov, the trial was posted on December 18th 2020 and last updated on November 11th 2022. The study requires 62 participants in total, which will be recruited from 7 locations."

Answered by AI

What is the intent of this experiment?

"The aim of this 18-week clinical trial is to study the efficacy of Tumor-infiltrating lymphocytes (TILs). Additionally, researchers will investigate how Changes in TILs affects patients' responses to treatment using a two-sample Wilcoxon rank sum test and logistic regression model. Finally, they hope to determine the Rate of Residual Cancer Burden (RCB) 0/1 response and Number of Participants With Treatment-Related NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0."

Answered by AI

Are there any safety concerns to be aware of before taking Niraparib?

"Niraparib's safety is based on preliminary data from Phase 2 trials, meaning that while there are no guarantees of efficacy, the medication appears to be safe."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Indiana
Florida
Other
How old are they?
65+
18 - 65
What site did they apply to?
Beth Israel Deaconess Medical Center
Vanderbilt-Ingram Cancer Center
Other
Baylor College of Medicine Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Vanderbilt-Ingram Cancer Center: < 24 hours
  2. Mayo Clinic: < 24 hours
  3. Beth Israel Deaconess Medical Center: < 24 hours
Average response time
  • < 1 Day
~4 spots leftby Jul 2024