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Niraparib + Dostarlimab In BRCA Mutated Breast Cancer
NCT04584255 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Niraparib
- DRUG Dostarlimab
Study Locations (8)
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
Connecticut
- Yale University Cancer Center — New Haven
Maryland
- Johns Hopkins University — Baltimore
Minnesota
- Mayo Clinic — Rochester
Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville
Washington
- University of Washington / Fred Hutchinson Cancer Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2029-07-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04584255
The ClinicalTrials.gov registry entry for NCT04584255 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Niraparib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04584255 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, Connecticut, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04584255 about?
NCT04584255 is a clinical study titled "Niraparib + Dostarlimab In BRCA Mutated Breast Cancer". 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
What is the current status of trial NCT04584255?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2020-12-18. Estimated completion is 2029-07-17.
What conditions does trial NCT04584255 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage I Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04584255?
The interventions under investigation include: Niraparib (DRUG), Dostarlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04584255?
This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04584255 being conducted?
This trial has 8 study locations across Connecticut, Maryland, Massachusetts, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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