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Neoplasms, BreastPhase 3ZESTNCT04915755

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 testing Niraparib in people with Neoplasms, Breast, run by GlaxoSmithKline at 198 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Breast
What is being tested?
Niraparib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
198 sitesin 27 countries
Study dates
28 Jun 2021to 31 Dec 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage I to III breast cancer with surgical resection of the primary tumor that is confirmed to be either: TNBC, irrespective of BRCA status or HR+/HER2- breast cancer with a known and documented deleterious or suspected deleterious tBRCA mutation.
  • Estrogen receptor (ER) and/or progesterone receptor (PgR) negativity is defined as immunohistochemistry (IHC) nuclear staining less than (<) 1 percentage (%), or by Allred scoring system where TNBC is defined to be 0 out of 8 or 2 out of 8, or staining in <1 % of cancer cells.
  • Completed prior standard therapy for curative intent.
  • Participants with HR+ breast cancer must be on a stable regimen of endocrine therapy.
  • Detectable ctDNA as measured by central testing.
  • 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.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

  • Prior treatment with a Poly Adenosine-diphosphate Ribose Polymerase (PARP) inhibitor.
  • Current treatment with a Cyclin-dependent kinase (CDK)4/6 inhibitor or endocrine therapy other than anastrozole, letrozole, exemestane, and tamoxifen with or without ovarian suppression.
  • Participants have any sign of metastasis or local recurrence after comprehensive assessment conducted per protocol.
  • Participants have shown no definitive response to preoperative chemotherapy by pathologic, radiographic or clinical evaluation, in cases where preoperative chemotherapy was administered.
  • Participants have inadequately treated or controlled hypertension.
  • Participants have received live vaccine within 30 days of planned start of study randomization.
Show all 11Show fewer
  • Participants have a second primary malignancy.
  • Exceptions are the following: (a) Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal carcinoma in situ (DCIS) of the breast, Stage I Grade 1 endometrial carcinoma. (b) Other solid tumors and lymphomas (without bone marrow involvement) diagnosed >=5 years prior to randomization and treated with no evidence of disease recurrence and for whom no more than 1 line of chemotherapy was applied.
  • Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment (except France).
  • Participant is immunocompromised. Participants with splenectomy are allowed. Participants with known human immunodeficiency virus (HIV) are allowed if they meet protocol-defined criteria.
  • Participants have a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Trial locations and contacts

198 sites in 27 countries.

198 sites in 27 countries

United States24 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87106

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Duarte, California, 91010

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Fargo, North Dakota, 58122

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Highlands Ranch, Colorado, 80045

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Palo Alto, California, 94304

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    San Antonio, Texas, 78240

  • GSK Investigational Site

    San Francisco, California, 94158

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57104

  • GSK Investigational Site

    Skokie, Illinois, 60076

  • GSK Investigational Site

    Tyler, Texas, 75702

Other trials in United States

Japan20 sites

  • GSK Investigational Site

    Aichi, 464-8681

  • GSK Investigational Site

    Chiba, 277-8577

  • GSK Investigational Site

    Ehime, 791-0280

  • GSK Investigational Site

    Fukuoka, 811-1395

  • GSK Investigational Site

    Hiroshima, 730-8518

  • GSK Investigational Site

    Hokkaido, 003-0804

  • GSK Investigational Site

    Kagoshima, 892-0833

  • GSK Investigational Site

    Kanagawa, 216-8511

  • GSK Investigational Site

    Kanagawa, 241-8515

  • GSK Investigational Site

    Kanagawa, 259-1143

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Osaka, 541-8567

  • GSK Investigational Site

    Osaka, 589-8511

  • GSK Investigational Site

    Saitama, 350-1298

  • GSK Investigational Site

    Saitama, 350-8550

  • GSK Investigational Site

    Saitama, 362-0806

  • GSK Investigational Site

    Tokyo, 104-0045

  • GSK Investigational Site

    Tokyo, 113-8431

  • GSK Investigational Site

    Tokyo, 135-8550

  • GSK Investigational Site

    Tokyo, 142-8666

Other trials in Japan

Italy14 sites

  • GSK Investigational Site

    Ancona, 60126

  • GSK Investigational Site

    Ancona, 62100

  • GSK Investigational Site

    Bologna, 40138

  • GSK Investigational Site

    Brindisi, 72100

  • GSK Investigational Site

    Candiolo to, 10060

  • GSK Investigational Site

    Catania, 95122

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Meldola FC, 47014

  • GSK Investigational Site

    Milan, 20141

  • GSK Investigational Site

    Milan, 20157

  • GSK Investigational Site

    Monza, 20900

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Negrar Verona, 37024

  • GSK Investigational Site

    Padova, 35128

Other trials in Italy

Spain14 sites

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08028

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Granada, 18016

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

United Kingdom12 sites

  • GSK Investigational Site

    Bath, BA1 3NG

  • GSK Investigational Site

    Brighton, BN2 5BE

  • GSK Investigational Site

    Cardiff, CF14 2TL

  • GSK Investigational Site

    Coventry, CV2 2DX

  • GSK Investigational Site

    Edinburgh, EH4 2XU

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    Maidstone, ME16 9QQ

  • GSK Investigational Site

    Manchester, M20 4BX

  • GSK Investigational Site

    Sutton, SM2 5PT

  • GSK Investigational Site

    Wigan, WN1 2NN

Other trials in United Kingdom

Argentina10 sites

  • GSK Investigational Site

    Buenos Aires, C1017 AAS

  • GSK Investigational Site

    Buenos Aires, C1125ABD

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Capital Federal, C1426ANZ

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1430EGF

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, C1015ABO

  • GSK Investigational Site

    Ciudad de Buenos Aires, C1118AAT

  • GSK Investigational Site

    Entre Ríos, 2822

Other trials in Argentina

Brazil10 sites

  • GSK Investigational Site

    Belo Horizonte, 30130-100

  • GSK Investigational Site

    Florianópolis, 88034-000

  • GSK Investigational Site

    Porto Alegre, 90020-090

  • GSK Investigational Site

    Porto Alegre, 90610000

  • GSK Investigational Site

    Rio de Janeiro, 20560-120

  • GSK Investigational Site

    Rio Grande, 95070-560

  • GSK Investigational Site

    Salvador, 40170-110

  • GSK Investigational Site

    São Paulo, 01317000

  • GSK Investigational Site

    São Paulo, 04312903

  • GSK Investigational Site

    Vitória, 29043-260

Other trials in Brazil

Poland10 sites

  • GSK Investigational Site

    Katowice, 40-514

  • GSK Investigational Site

    Krakow, 31-115

  • GSK Investigational Site

    Krakow, 31-501

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Poznan, 61-866

  • GSK Investigational Site

    Rzeszów, 35-021

  • GSK Investigational Site

    Siedlce, 08-110

  • GSK Investigational Site

    Szczecin, 70-707

  • GSK Investigational Site

    Warsaw, 02-781

  • GSK Investigational Site

    Wroclaw, 53-413

Other trials in Poland

France9 sites

  • GSK Investigational Site

    Avignon, 84918

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Caen, 14000

  • GSK Investigational Site

    Dijon, 21000

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Montpellier, 34070

  • GSK Investigational Site

    Pierre-Bénite, 69495

  • GSK Investigational Site

    Rouen, 76000

  • GSK Investigational Site

    Saint-Cloud, 92210

Other trials in France

Russia9 sites

  • GSK Investigational Site

    Chelyabinsk, 454048

  • GSK Investigational Site

    Moscow, 111123

  • GSK Investigational Site

    Moscow, 121309

  • GSK Investigational Site

    Moscow, 143422

  • GSK Investigational Site

    Omsk, 644013

  • GSK Investigational Site

    Pushkin, 196603

  • GSK Investigational Site

    Saint Petersburg, 197110

  • GSK Investigational Site

    Saint Petersburg, 197758

  • GSK Investigational Site

    StPetersburg, 197022

Other trials in Russia

Romania8 sites

  • GSK Investigational Site

    Bucharest, 011171

  • GSK Investigational Site

    Bucharest, 020142

  • GSK Investigational Site

    Bucharest, 021389

  • GSK Investigational Site

    Bucharest, 022343

  • GSK Investigational Site

    Cluj-Napoca, 400015

  • GSK Investigational Site

    Craiova, 200347

  • GSK Investigational Site

    Otopeni, 075100

  • GSK Investigational Site

    Timișoara, 300239

Other trials in Romania

Germany7 sites

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Cologne, 50935

  • GSK Investigational Site

    Erlangen, 91054

  • GSK Investigational Site

    Essen, 45136

  • GSK Investigational Site

    Mannheim, 68167

  • GSK Investigational Site

    München, 81377

  • GSK Investigational Site

    Ulm, 89075

Other trials in Germany

Israel7 sites

  • GSK Investigational Site

    Beersheba, 84101

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Jerusalem, 91031

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Netherlands6 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    Rotterdam, 3083 AN

  • GSK Investigational Site

    The Hague, 2545 AA

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Belgium5 sites

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Charleroi, 6000

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

Canada5 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Québec, Quebec, G1S 4L8

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Austria4 sites

  • GSK Investigational Site

    Feldkirch, A-6830

  • GSK Investigational Site

    Innsbruck, 6020

  • GSK Investigational Site

    Steyr, 4400

  • GSK Investigational Site

    Vienna, A-1090

Other trials in Austria

Mexico4 sites

  • GSK Investigational Site

    León, 37178

  • GSK Investigational Site

    Mexico City, 04980

  • GSK Investigational Site

    Monterrey, 64460

  • GSK Investigational Site

    Monterrey, 66278

Other trials in Mexico

Australia3 sites

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Macquarie Park, New South Wales, 2109

  • GSK Investigational Site

    North Sydney, New South Wales, 2060

Other trials in Australia

Chile3 sites

  • GSK Investigational Site

    Santiago, 7500653

  • GSK Investigational Site

    Santiago, 7500836

  • GSK Investigational Site

    Temuco, 5360000

Other trials in Chile

Finland3 sites

  • GSK Investigational Site

    Helsinki, 00180

  • GSK Investigational Site

    Helsinki, HUS 00029

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

South Africa3 sites

  • GSK Investigational Site

    Cape Town, 7700

  • GSK Investigational Site

    Port Elizabeth, 6045

  • GSK Investigational Site

    Pretoria, 0041

Other trials in South Africa

Ireland2 sites

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dublin, 9

Other trials in Ireland

Norway2 sites

  • GSK Investigational Site

    Drammen, N-3004

  • GSK Investigational Site

    Stavanger, 4011

Other trials in Norway

Portugal2 sites

  • GSK Investigational Site

    Lisbon, 1649-035

  • GSK Investigational Site

    Loures, 2674-514

Other trials in Portugal

Hungary1 site

  • GSK Investigational Site

    Debrecen, 4032

Other trials in Hungary

Switzerland1 site

  • GSK Investigational Site

    Basel, 4031

Other trials in Switzerland

About this study

Official title: A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)

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.

Being tested
Niraparib, Placebo
Keywords
Niraparib, Breast cancer susceptibility gene, Human epidermal growth factor-2 negative (HER2), Breast cancer, Triple negative breast cancer (TNBC), Circulating tumor Deoxyribonucleic acid (ctDNA)
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Niraparib will be administered.

  • PlaceboDrug

    Matching placebo will be administered

Study groups in NCT04915755
Study groupRoleWhat they receive
Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)ExperimentalEligible participants will receive either Niraparib or Placebo.
Receives: Drug: Niraparib; Drug: Placebo
Cohort 2: Participants with tBRCAwt TNBCExperimentalEligible participants will receive either Niraparib or Placebo.
Receives: Drug: Niraparib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

    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 associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AESI is any AE (serious or nonserious) that is of scientific and medical concern specific to niraparib for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is warranted. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Measured: Up to approximately 125 weeks

  2. Number of Participants With TEAEs Leading to Death

    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. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state.Number of participants with TEAEs leading to death were reported.

    Measured: Up to approximately 125 weeks

  3. Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment

    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. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. Number of participants with TEAEs leading to dose modifications (reduction and interruption/delay) and permanent discontinuation of study treatment were reported.

    Measured: Up to approximately 125 weeks

  4. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

    Number of participants with ECOG Performance Status was reported and was measured on 6-point grade scale 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead. Data is presented as baseline grade, best case on-therapy, and worst-case on-therapy for the available participants.

    Measured: Up to approximately 125 weeks

  5. Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline

    Blood samples were collected for the analysis of hematology parameters. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest non-missing pre-dose value, including those from unscheduled visits.

    Measured: Up to approximately 125 weeks

  6. Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline

    Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Baseline is defined as the latest non-missing pre-dose value, including those from unscheduled visits.

    Measured: Up to approximately 125 weeks

  7. Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline

    The abnormal vital sign ranges are: Pulse Rate (PR): Low [<60 beats per minute (bpm)], Normal (60 bpm to 100 bpm), High (>100 bpm); Temperature: Low (<35 degree Celsius (°C)), Normal (35 C and 38 C), High (>38 C); Systolic Blood Pressure (SBP): Low (<90 millimeter of mercury (mmHg)), Normal (>90 mmHg to <120 mmHg), High (>120 mmHg); Diastolic Blood Pressure (DBP): Low (<60 mmHg), Normal (60 mmHg to 79 mmHg), High (>80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category.

    Measured: Up to approximately 125 weeks

  8. Number of Participants With Use of Concomitant Medications

    Number of participants who used concomitant medications is presented.

    Measured: Up to approximately 125 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start28 Jun 2021
  3. Primary completion28 Jun 2024
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04915755
Sponsor's protocol ID
213831
Other IDs
2020-003973-23
Acronym
ZEST
Status last verified
Jun 2025
First submitted
1 Jun 2021
Last updated
16 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib in people with Neoplasms, Breast, run by GlaxoSmithKline at 198 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, Japan, Italy, Spain, United Kingdom and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) (time frame: Up to approximately 125 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04915755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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