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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: Active Phase 3 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associate
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04915755 still lists
NCT04915755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,063-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (96% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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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 NCT04915755's enrollment target sits among peer trials
40 9th of 9 higher than 1 of 9 other Neoplasms, Breast trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms, Breast 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.
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