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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
Must not have
Participants have inadequately treated or controlled hypertension
Participants have shown no definitive response to preoperative chemotherapy by pathologic, radiographic or clinical evaluation, in cases where preoperative chemotherapy was administered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing Niraparib, a drug that stops cancer cells from fixing their broken DNA, in patients with certain types of breast cancer that are either genetically aggressive or have signs of remaining disease after treatment. Niraparib is a drug already used for ovarian cancer and has shown promise in treating breast cancer with certain genetic markers.

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.
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.
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.

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.
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I am on a consistent hormone therapy for my HR+ breast cancer.
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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.
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My breast cancer is not driven by estrogen or progesterone.
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I am fully active or can carry out light work.
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I have finished all recommended treatments aimed at curing my disease.
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I have finished all my recommended treatments aimed at curing my condition.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is either triple-negative or hormone-receptor positive/HER2-negative with a harmful BRCA mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not well-controlled.
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My cancer did not respond to the chemotherapy given before surgery.
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I have a history of MDS or AML.
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My cancer has spread or returned after a full check-up.
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I have been treated with a PARP inhibitor before.
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I am currently on a CDK4/6 inhibitor or hormone therapy not listed as anastrozole, letrozole, exemestane, or tamoxifen.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
Abdominal pain
22%
Dizziness
22%
Insomnia
22%
Dyspnea
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Cough
9%
Dehydration
9%
Urinary tract infection
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Upper respiratory infection
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Postnasal drip
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Hyperkalemia
4%
Peripheral sensory neuropathy
4%
Leukocytosis
4%
White blood cell decreased
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~2400
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,808 Previous Clinical Trials
8,381,335 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,675 Total Patients Enrolled

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
~10 spots leftby Dec 2025
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