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PARP Inhibitor

Niraparib for Breast Cancer (ZEST Trial)

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
An archival tumor tissue specimen of the primary tumor sufficient in quality and quantity for ctDNA assay design and tBRCA and Homologous recombination deficiency (HRD) testing is required
Participants with HR+ breast cancer must be on a stable regimen of endocrine therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

ZEST Trial Summary

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.

Who is the study for?
This trial is for individuals with HER2- breast cancer who have a BRCA gene mutation or triple-negative breast cancer (TNBC) and detectable circulating tumor DNA (ctDNA). They must have completed standard therapy, be in good physical condition (ECOG 0 or 1), and if HR+, on stable endocrine therapy. Exclusions include prior PARP inhibitor treatment, signs of metastasis, certain health conditions like uncontrolled hypertension, recent live vaccines, some other cancers, and pregnancy.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Niraparib versus a placebo in patients with specific types of breast cancer after surgery or adjuvant therapy. It focuses on those with genetic mutations in BRCA or TNBC who show molecular disease through ctDNA presence.See study design
What are the potential side effects?
While not specified here, common side effects of Niraparib may include nausea, fatigue, blood cell count changes leading to anemia or infection risk increase; heart rate issues; liver function changes; mouth sores; muscle pain; respiratory complications like coughing or shortness of breath.

ZEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a tissue sample from my original tumor for DNA testing.
Select...
I am on a consistent hormone therapy for my HR+ breast cancer.
Select...
My breast cancer is stage I to III and has been surgically removed. It is either triple-negative or hormone receptor-positive/HER2-negative with a harmful BRCA mutation.
Select...
My breast cancer is not driven by estrogen or progesterone.
Select...
I am fully active or can carry out light work.
Select...
I have finished all recommended treatments aimed at curing my disease.
Select...
I have finished all my recommended treatments aimed at curing my condition.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is either triple-negative or hormone-receptor positive/HER2-negative with a harmful BRCA mutation.

ZEST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
Number of participants with clinically significant changes in relevant laboratory parameters
Number of participants with clinically significant changes in vital signs
+2 more
Secondary outcome measures
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (Scores on a scale)
Change from Baseline in the Functional Assessment of Cancer Therapy - General Population(FACT-GP5) (Scores on a scale)
Distant recurrence-free survival (DRFS)
+5 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

ZEST Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)Experimental Treatment2 Interventions
Eligible participants will receive either Niraparib or Placebo.
Group II: Cohort 2: Participants with tBRCAwt TNBCExperimental Treatment2 Interventions
Eligible participants will receive either Niraparib or Placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,412 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,304 Patients Enrolled for Breast Cancer
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,890 Total Patients Enrolled
2 Trials studying Breast Cancer
2,323,730 Patients Enrolled for Breast Cancer

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04915755 — Phase 3
Breast Cancer Research Study Groups: Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC), Cohort 2: Participants with tBRCAwt TNBC
Breast Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT04915755 — Phase 3
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04915755 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project open to new participants?

"Yes. The clinical trial is enrolling 800 participants between 27 locations, as stated on clinicaltrials.gov."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Virginia
Other
California
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
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
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.
All > Breast Cancer Albuquerque
~9 spots leftby Mar 2025
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