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NCT04915755 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

A Phase 3 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.

Active
Registry status
Phase 3
Development phase
40
Enrollment target
20
Study locations

NCT04915755 is a Phase 3 study of Neoplasms, Breast that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 40 participants, below the 1,063-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT04915755, a Phase 3 study of Neoplasms, Breast, is active but no longer recruiting, sponsored by GlaxoSmithKline.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
40 participants
Enrollment target
20
Study locations

Study Summary

This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor \[HR\] status, including HR positive \[+\] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

Conditions Studied

Neoplasms, Breast

Interventions

  • DRUG Placebo
  • DRUG Niraparib

Study Locations (20)

Texas

  • GSK Investigational Site - Austin
  • GSK Investigational Site - Dallas
  • GSK Investigational Site - Dallas
  • GSK Investigational Site - Fort Worth
  • GSK Investigational Site - Houston

California

  • GSK Investigational Site - Burbank
  • GSK Investigational Site - Duarte
  • GSK Investigational Site - Palo Alto
  • GSK Investigational Site - San Francisco

Colorado

  • GSK Investigational Site - Aurora
  • GSK Investigational Site - Highlands Ranch

Illinois

  • GSK Investigational Site - Chicago
  • GSK Investigational Site - Skokie

Pennsylvania

  • GSK Investigational Site - Philadelphia
  • GSK Investigational Site - Pittsburgh

Michigan

  • GSK Investigational Site - Ann Arbor

New Mexico

  • GSK Investigational Site - Albuquerque

New York

  • GSK Investigational Site - New York

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2021-06-28
Est. Completion 2025-12-31
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04915755

The ClinicalTrials.gov registry entry for NCT04915755 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,063-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (96% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04915755 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04915755 about?

NCT04915755 is a clinical study titled "Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease". This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor \[HR\] status, including HR positive \[+\] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease b...

What is the current status of trial NCT04915755?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2021-06-28. Estimated completion is 2025-12-31.

What conditions does trial NCT04915755 study?

This clinical trial studies the following conditions: Neoplasms, Breast.

What interventions are being tested in trial NCT04915755?

The interventions under investigation include: Placebo (DRUG), Niraparib (DRUG).

Who is sponsoring clinical trial NCT04915755?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04915755 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Michigan, New Mexico. 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

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.