This trial will test the effectiveness of Niraparib in treating breast cancer in participants with either a BRCA gene mutation or BRCA wild type. Participants who have completed cancer treatment in the past are eligible for this trial.
- Breast Cancer
1 Primary · 10 Secondary · Reporting Duration: Up to 8 years
Side Effects for
3 Treatment Groups
Cohort1 Participants with tBRCAmut HER2-breast cancer(Independent of HR status,i...
1 of 3
Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,i...
1 of 3
Cohort 2: Participants with tBRCAwt TNBC
1 of 3
800 Total Participants · 3 Treatment Groups
Primary Treatment: Niraparib · Has Placebo Group · Phase 3
Who is running the clinical trial?
Age 18+ · All Participants · 12 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
|18 - 65||100.0%|
What site did they apply to?
|GSK Investigational Site||100.0%|
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
- 2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04915755.
Frequently Asked Questions
Is this research project open to new participants?
"Yes. The clinical trial is enrolling 800 participants between 27 locations, as stated on clinicaltrials.gov." - Anonymous Online Contributor
What are the long-term risks of taking Niraparib?
"Niraparib is considered safe based on its Phase 3 status, as well as the efficacy data and multiple rounds of safety testing." - Anonymous Online Contributor
What other opportunities for research exist with Niraparib?
"Currently, there are 97 Niraparib trials underway with 13 of them in Phase 3. The majority of these Washington, D.C., however 2639 locations worldwide are running these studies." - Anonymous Online Contributor
What other similar studies have been conducted in the past?
"Research into niraparib began in 2016 with a clinical trial that was sponsored by Myriad Genetics, Inc. After the Phase 3 drug approval in 2016, 97 live trials for Niraparib are ongoing in 478 cities and 49 countries." - Anonymous Online Contributor
How large is the study group for this research?
"Yes, you are correct. The information available on clinicaltrials.gov affirms that this study is currently looking for participants. The trial was originally posted on June 28th, 2021 and the most recent update was on September 29th, 2022. They are hoping to enroll 800 individuals total at 27 sites." - Anonymous Online Contributor