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 (ZEST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms, Breast
• Intervention / Treatment: Drug: Placebo; Drug: Niraparib

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1125ABD
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1017 AAS
    • GSK Investigational Site
  • Capital Federal, Argentina, C1426ANZ
    • GSK Investigational Site
  • Cipoletti Rio Negro, Argentina, R8324CVE
    • GSK Investigational Site
  • Ciudad AutOnoma de Buenos Aire, Argentina, C1015ABO
    • GSK Investigational Site
  • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
    • GSK Investigational Site
  • Ciudad de Buenos Aires, Argentina, C1118AAT
    • GSK Investigational Site
  • Entre Rios, Argentina, 2822
    • GSK Investigational Site
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • GSK Investigational Site
    • Macquarie Park, New South Wales, Australia, 2109
      • GSK Investigational Site
    • North Sydney, New South Wales, Australia, 2060
      • GSK Investigational Site
• Austria
  • Feldkirch, Austria, A-6830
    • GSK Investigational Site
  • Innsbruck, Austria, 6020
    • GSK Investigational Site
  • Steyr, Austria, 4400
    • GSK Investigational Site
  • Wien, Austria, A-1090
    • GSK Investigational Site
• Belgium
  • Bruxelles, Belgium, 1200
    • GSK Investigational Site
  • Bruxelles, Belgium, 1070
    • GSK Investigational Site
  • Charleroi, Belgium, 6000
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
• Brazil
  • Belo Horizonte, Brazil, 30130-100
    • GSK Investigational Site
  • Florianopolis, Brazil, 88034-000
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90020-090
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90610000
    • GSK Investigational Site
  • Rio Grande Do Sul, Brazil, 95070-560
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 20560-120
    • GSK Investigational Site
  • SAo Paulo, Brazil, 01317000
    • GSK Investigational Site
  • Salvador, Brazil, 40170-110
    • GSK Investigational Site
  • Sao Paulo, Brazil, 04312903
    • GSK Investigational Site
  • VitOria, Brazil, 29043-260
    • GSK Investigational Site
• Canada
  • Quebec, Canada, G1S 4L8
    • GSK Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • GSK Investigational Site
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • GSK Investigational Site
• Chile
  • Santiago, Chile, 7500653
    • GSK Investigational Site
  • Santiago, Chile, 7500836
    • GSK Investigational Site
  • Temuco, Chile, 5360000
    • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00180
    • GSK Investigational Site
  • Helsinki, Finland, HUS 00029
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• France
  • Avignon, France, 84918
    • GSK Investigational Site
  • Bordeaux, France, 33076
    • GSK Investigational Site
  • Caen Cedex 5, France, 14000
    • GSK Investigational Site
  • Dijon Cedex, France, 21000
    • GSK Investigational Site
  • Marseille, France, 13915
    • GSK Investigational Site
  • Montpellier, France, 34070
    • GSK Investigational Site
  • Pierre Benite, France, 69495
    • GSK Investigational Site
  • Rouen Cedex 1, France, 76000
    • GSK Investigational Site
  • Saint-Cloud, France, 92210
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13125
    • GSK Investigational Site
  • Erlangen, Germany, 91054
    • GSK Investigational Site
  • Essen, Germany, 45136
    • GSK Investigational Site
  • Koeln, Germany, 50935
    • GSK Investigational Site
  • Mannheim, Germany, 68167
    • GSK Investigational Site
  • Muenchen, Germany, 81377
    • GSK Investigational Site
  • Ulm, Germany, 89075
    • GSK Investigational Site
• Hungary
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
• Ireland
  • Dublin, Ireland, 8
    • GSK Investigational Site
  • Dublin 9, Ireland, 9
    • GSK Investigational Site
• Israel
  • Beer-Sheva, Israel, 84101
    • GSK Investigational Site
  • Haifa, Israel, 31096
    • GSK Investigational Site
  • Jerusalem, Israel, 91031
    • GSK Investigational Site
  • Jerusalem, Israel, 91120
    • GSK Investigational Site
  • Petach Tikva, Israel, 49100
    • GSK Investigational Site
  • Rehovot, Israel, 76100
    • GSK Investigational Site
  • Tel Aviv, Israel, 64239
    • GSK Investigational Site
• Italy
  • Ancona, Italy, 60126
    • GSK Investigational Site
  • Ancona, Italy, 62100
    • GSK Investigational Site
  • Bologna, Italy, 40138
    • GSK Investigational Site
  • Brindisi, Italy, 72100
    • GSK Investigational Site
  • Candiolo TO, Italy, 10060
    • GSK Investigational Site
  • Catania, Italy, 95122
    • GSK Investigational Site
  • Genova, Italy, 16132
    • GSK Investigational Site
  • Meldola FC, Italy, 47014
    • GSK Investigational Site
  • Milano, Italy, 20157
    • GSK Investigational Site
  • Milano, Italy, 20141
    • GSK Investigational Site
  • Monza, Italy, 20900
    • GSK Investigational Site
  • Napoli, Italy, 80131
    • GSK Investigational Site
  • Negrar Verona, Italy, 37024
    • GSK Investigational Site
  • Padova, Italy, 35128
    • GSK Investigational Site
• Japan
  • Aichi, Japan, 464-8681
    • GSK Investigational Site
  • Chiba, Japan, 277-8577
    • GSK Investigational Site
  • Ehime, Japan, 791-0280
    • GSK Investigational Site
  • Fukuoka, Japan, 811-1395
    • GSK Investigational Site
  • Hiroshima, Japan, 730-8518
    • GSK Investigational Site
  • Hokkaido, Japan, 003-0804
    • GSK Investigational Site
  • Kagoshima, Japan, 892-0833
    • GSK Investigational Site
  • Kanagawa, Japan, 259-1143
    • GSK Investigational Site
  • Kanagawa, Japan, 216-8511
    • GSK Investigational Site
  • Kanagawa, Japan, 241-8515
    • GSK Investigational Site
  • Okayama, Japan, 700-8558
    • GSK Investigational Site
  • Osaka, Japan, 589-8511
    • GSK Investigational Site
  • Osaka, Japan, 541-8567
    • GSK Investigational Site
  • Saitama, Japan, 350-8550
    • GSK Investigational Site
  • Saitama, Japan, 350-1298
    • GSK Investigational Site
  • Saitama, Japan, 362-0806
    • GSK Investigational Site
  • Tokyo, Japan, 142-8666
    • GSK Investigational Site
  • Tokyo, Japan, 104-0045
    • GSK Investigational Site
  • Tokyo, Japan, 135-8550
    • GSK Investigational Site
  • Tokyo, Japan, 113-8431
    • GSK Investigational Site
• Mexico
  • Ciudad de Mexico, Mexico, 04980
    • GSK Investigational Site
  • Leon Guanajuato, Mexico, 37178
    • GSK Investigational Site
  • Monterrey, Mexico, 64460
    • GSK Investigational Site
  • Monterrey, Mexico, 66278
    • GSK Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • GSK Investigational Site
  • Den Haag, Netherlands, 2545 AA
    • GSK Investigational Site
  • Leeuwarden, Netherlands, 8934 AD
    • GSK Investigational Site
  • Maastricht, Netherlands, 6229 HX
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3083 AN
    • GSK Investigational Site
  • Zwolle, Netherlands, 8025 AB
    • GSK Investigational Site
• Norway
  • Drammen, Norway, N-3004
    • GSK Investigational Site
  • Stavanger, Norway, 4011
    • GSK Investigational Site
• Poland
  • Katowice, Poland, 40-514
    • GSK Investigational Site
  • Krakow, Poland, 31-115
    • GSK Investigational Site
  • Krakow, Poland, 31-501
    • GSK Investigational Site
  • Olsztyn, Poland, 10-228
    • GSK Investigational Site
  • Poznan, Poland, 61-866
    • GSK Investigational Site
  • Rzeszow, Poland, 35-021
    • GSK Investigational Site
  • Siedlce, Poland, 08-110
    • GSK Investigational Site
  • Szczecin, Poland, 70-707
    • GSK Investigational Site
  • Warszawa, Poland, 02-781
    • GSK Investigational Site
  • Wroclaw, Poland, 53-413
    • GSK Investigational Site
• Portugal
  • Lisboa, Portugal, 1649-035
    • GSK Investigational Site
  • Loures, Portugal, 2674-514
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 020142
    • GSK Investigational Site
  • Bucharest, Romania, 011171
    • GSK Investigational Site
  • Bucharest, Romania, 022343
    • GSK Investigational Site
  • Bucuresti, Romania, 021389
    • GSK Investigational Site
  • Cluj-Napoca, Romania, 400015
    • GSK Investigational Site
  • Craiova, Romania, 200347
    • GSK Investigational Site
  • Otopeni, Romania, 075100
    • GSK Investigational Site
  • Timisoara, Romania, 300239
    • GSK Investigational Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • GSK Investigational Site
  • Moscow, Russian Federation, 121309
    • GSK Investigational Site
  • Moscow, Russian Federation, 111123
    • GSK Investigational Site
  • Moscow, Russian Federation, 143422
    • GSK Investigational Site
  • Omsk, Russian Federation, 644013
    • GSK Investigational Site
  • Pushkin, Russian Federation, 196603
    • GSK Investigational Site
  • Saint Petersburg, Russian Federation, 197110
    • GSK Investigational Site
  • St Petersburg, Russian Federation, 197758
    • GSK Investigational Site
  • StPetersburg, Russian Federation, 197022
    • GSK Investigational Site
• South Africa
  • Cape Town, South Africa, 7700
    • GSK Investigational Site
  • Port Elizabeth, South Africa, 6045
    • GSK Investigational Site
  • Pretoria, South Africa, 0041
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • Barcelona, Spain, 08028
    • GSK Investigational Site
  • Caceres, Spain, 10003
    • GSK Investigational Site
  • Cordoba, Spain, 14004
    • GSK Investigational Site
  • Granada, Spain, 18016
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28050
    • GSK Investigational Site
  • Malaga, Spain, 29010
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
  • Zaragoza, Spain, 50009
    • GSK Investigational Site
• Switzerland
  • Basel, Switzerland, 4031
    • GSK Investigational Site
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • GSK Investigational Site
  • Brighton, United Kingdom, BN2 5BE
    • GSK Investigational Site
  • Cardiff, United Kingdom, CF14 2TL
    • GSK Investigational Site
  • Coventry, United Kingdom, CV2 2DX
    • GSK Investigational Site
  • Edinburgh, United Kingdom, EH4 2XU
    • GSK Investigational Site
  • Leeds, United Kingdom, LS9 7TF
    • GSK Investigational Site
  • London, United Kingdom, SE1 9RT
    • GSK Investigational Site
  • London, United Kingdom, SW3 6JJ
    • GSK Investigational Site
  • Maidstone, United Kingdom, ME16 9QQ
    • GSK Investigational Site
  • Manchester, United Kingdom, M20 4BX
    • GSK Investigational Site
  • Sutton, United Kingdom, SM2 5PT
    • GSK Investigational Site
  • Wigan, United Kingdom, WN1 2NN
    • GSK Investigational Site
• United States
  • California
    • Burbank, California, United States, 91505
      • GSK Investigational Site
    • Duarte, California, United States, 91010
      • GSK Investigational Site
    • Palo Alto, California, United States, 94304
      • GSK Investigational Site
    • San Francisco, California, United States, 94158
      • GSK Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • GSK Investigational Site
    • Highlands Ranch, Colorado, United States, 80045
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
    • Skokie, Illinois, United States, 60076
      • GSK Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10032
      • GSK Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78731
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75231
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77024
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78240
      • GSK Investigational Site
    • Tyler, Texas, United States, 75702
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site
  • Washington
    • Everett, Washington, United States, 98201
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC); Eligible participants will receive either Niraparib or Placebo.	Drug: Placebo; Matching placebo will be administered; Drug: Niraparib; Niraparib will be administered.
Experimental: Cohort 2: Participants with tBRCAwt TNBC; Eligible participants will receive either Niraparib or Placebo.	Drug: Placebo; Matching placebo will be administered; Drug: Niraparib; Niraparib will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 125 weeks
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.	Up to approximately 125 weeks
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.	Up to approximately 125 weeks
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.	Up to approximately 125 weeks
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.	Up to approximately 125 weeks
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.	Up to approximately 125 weeks
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.	Up to approximately 125 weeks
Number of Participants With Use of Concomitant Medications	Number of participants who used concomitant medications is presented.	Up to approximately 125 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from randomization to the date of death by any cause.	Up to 8 years
Time to progression on next anticancer therapy (TTP)	Time to progression is defined as the time from randomization to the earliest progression event subsequent to that used for the primary variable DFS or death by any cause.	Up to 8 years
Distant recurrence-free survival (DRFS)	DRFS is defined as the time from randomization to the first detection of distant metastasis or death by any cause.	Up to 4 years
Number of participants with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), adverse events of special interest (AESIs), TEAEs leading to death, TEAEs leading to dose modifications and discontinuation	Number of participants with TEAEs, SAEs, AESIs, TEAEs leading to death, TEAEs leading to dose modifications and discontinuation will be summarized.	Up to 8 years
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (Scores on a scale)	EORTC-QLQC 30 is a 30 item questionnaire developed to assess the quality of life of cancer participants.	Baseline (Day 1) and up to 8 years
Change from Baseline in the Functional Assessment of Cancer Therapy - General Population(FACT-GP5) (Scores on a scale)	The FACT-GP5 item is a single item from the FACT-G, which assesses how bothersome the side effects of treatment are for participants with cancer.	Baseline (Day 1) and up to 8 years
Patient reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (Scores on a scale)	The PRO-CTCAE is a PRO measure developed to evaluate symptomatic toxicity in participants with cancer.	Baseline (Day 1) and up to 8 years
Number of participants with clinically significant changes in laboratory parameters, vital signs, Eastern Cooperative Oncology Group (ECOG) status, and use of concomitant medications	Number of participants with clinically significant changes in laboratory parameters, vital signs, ECOG status, and use of concomitant medications will be evaluated	Up to 8 years

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): June 28, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Niraparib; Triple negative breast cancer (TNBC); Breast cancer susceptibility gene; Human epidermal growth factor-2 negative (HER2); Circulating tumor Deoxyribonucleic acid (ctDNA)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Poly(ADP-ribose) Polymerase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Niraparib
• Other Study ID Numbers: 213831; 2020-003973-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No