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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
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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.
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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%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Dehydration
9%
Blood bilirubin increased
9%
Dry mouth
9%
Anxiety
9%
Back pain
9%
Alanine aminotransferase increased
9%
Cough
9%
Urinary tract infection
9%
Hypertension
9%
Non-cardiac chest pain
4%
Hot flashes
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Leukocytosis
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Diarrhea
4%
Esophageal ulcer
4%
Head injury
4%
Skin tear
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Flu like symptoms
4%
Tremor
4%
Hyperglycemia
4%
Bruising
4%
Hematuria
4%
Depression
4%
Unknown infection
4%
Upper respiratory infection
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
4,766 Previous Clinical Trials
8,105,546 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,304 Patients Enrolled for Breast Cancer
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,298 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
~8 spots leftby Mar 2025
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