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NCT04584255 · ClinicalTrials.gov registry record · Phase 2
Niraparib + Dostarlimab In BRCA Mutated Breast Cancer
A Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 8
- Study locations
NCT04584255: Active Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT04584255 is a Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 62 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04584255, a Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 8
- Study locations
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
Primary Outcome
The primary evaluation of change in TILs within each arm will be based on a Wilcoxon signed rank test (absolute difference) using a one-sided alpha = 0.05 for each arm
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 |
What the registry record for NCT04584255 still lists
NCT04584255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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.
NCT04584255 lists 8 locations in 6 states (Massachusetts, Connecticut, Maryland).
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.
What interventions are being tested in trial NCT04584255?
The interventions under investigation include: Niraparib (DRUG), Dostarlimab (DRUG).
Who is sponsoring clinical trial NCT04584255?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04584255's enrollment target sits among peer trials
62 731st of 1224 higher than 491 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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