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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 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.

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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

Conditions Studied

Breast Cancer HER2-Negative Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Stage I Breast Cancer Germline BRCA1 Gene Mutation Germline BRCA2 Gene Mutation Deleterious PALB2 Gene Mutation

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

FieldValue
Enrollment Target 62 participants
Start Date 2020-12-18
Est. Completion 2029-07-17
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

781 total trials

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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, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.