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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)

Primary Purpose

Neoplasms, Breast

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Niraparib
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Breast focused on measuring Niraparib, Breast cancer susceptibility gene, Human epidermal growth factor-2 negative (HER2), Breast cancer, Triple negative breast cancer (TNBC), Circulating tumor Deoxyribonucleic acid (ctDNA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • 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.
  • 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).

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)

Cohort 2: Participants with tBRCAwt TNBC

Arm Description

Eligible participants will receive either Niraparib or Placebo.

Eligible participants will receive either Niraparib or Placebo.

Outcomes

Primary Outcome Measures

Number of participants with treatment emergent adverse event (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Number of participants with TEAEs, SAEs, and AESIs will be assessed.
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Change in ECOG performance from baseline will be assessed.
Number of participants with clinically significant changes in relevant laboratory parameters
Number of participants with clinically significant changes in hematology and clinical chemistry parameters will be assessed.
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs will be assessed.
Number of participants with use of concomitant medications
Number of participants using concomitant medications will be assessed.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2021
Last Updated
August 4, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04915755
Brief Title
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
Acronym
ZEST
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
March 12, 2025 (Anticipated)
Study Completion Date
August 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Breast
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)
Arm Type
Experimental
Arm Description
Eligible participants will receive either Niraparib or Placebo.
Arm Title
Cohort 2: Participants with tBRCAwt TNBC
Arm Type
Experimental
Arm Description
Eligible participants will receive either Niraparib or Placebo.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Intervention Description
Niraparib will be administered.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse event (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Description
Number of participants with TEAEs, SAEs, and AESIs will be assessed.
Time Frame
Up to approximately 34 months
Title
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
Description
The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Change in ECOG performance from baseline will be assessed.
Time Frame
Up to approximately 34 months
Title
Number of participants with clinically significant changes in relevant laboratory parameters
Description
Number of participants with clinically significant changes in hematology and clinical chemistry parameters will be assessed.
Time Frame
Up to approximately 34 months
Title
Number of participants with clinically significant changes in vital signs
Description
Number of participants with clinically significant changes in vital signs will be assessed.
Time Frame
Up to approximately 34 months
Title
Number of participants with use of concomitant medications
Description
Number of participants using concomitant medications will be assessed.
Time Frame
Up to approximately 34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
GSK Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
GSK Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
GSK Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
GSK Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
GSK Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
GSK Investigational Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
GSK Investigational Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
GSK Investigational Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
GSK Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
State/Province
Córdova
ZIP/Postal Code
X5000EDC
Country
Argentina
Facility Name
GSK Investigational Site
City
Gualeguaychu
State/Province
Entre Ríos
ZIP/Postal Code
2822
Country
Argentina
Facility Name
GSK Investigational Site
City
Cipoletti, Rio Negro
State/Province
Río Negro
ZIP/Postal Code
R8324CVE
Country
Argentina
Facility Name
GSK Investigational Site
City
Capital Federal, Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1017 AAS
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
GSK Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
GSK Investigational Site
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
GSK Investigational Site
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
GSK Investigational Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
GSK Investigational Site
City
Rankweil
ZIP/Postal Code
A-6830
Country
Austria
Facility Name
GSK Investigational Site
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
GSK Investigational Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
GSK Investigational Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
GSK Investigational Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Ondina
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
GSK Investigational Site
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29043-260
Country
Brazil
Facility Name
GSK Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
GSK Investigational Site
City
Caxias do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95070-560
Country
Brazil
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
GSK Investigational Site
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
GSK Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
01317000
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
04312903
Country
Brazil
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
GSK Investigational Site
City
Temuco
State/Province
Región De La Araucania
ZIP/Postal Code
5360000
Country
Chile
Facility Name
GSK Investigational Site
City
Providencia
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500653
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500836
Country
Chile
Facility Name
GSK Investigational Site
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
GSK Investigational Site
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
GSK Investigational Site
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
GSK Investigational Site
City
Monteria
ZIP/Postal Code
230018
Country
Colombia
Facility Name
GSK Investigational Site
City
Pereira
ZIP/Postal Code
660001
Country
Colombia
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
HUS 00029
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Avignon Cedex 9
ZIP/Postal Code
84918
Country
France
Facility Name
GSK Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
GSK Investigational Site
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
GSK Investigational Site
City
Clermont-Ferrand cedex
ZIP/Postal Code
63011
Country
France
Facility Name
GSK Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
GSK Investigational Site
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
GSK Investigational Site
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
GSK Investigational Site
City
Pierre-Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
GSK Investigational Site
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
GSK Investigational Site
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
GSK Investigational Site
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
GSK Investigational Site
City
Offenbach
State/Province
Hessen
ZIP/Postal Code
63069
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50935
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
GSK Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
GSK Investigational Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
GSK Investigational Site
City
Győr
ZIP/Postal Code
9022
Country
Hungary
Facility Name
GSK Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
GSK Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
GSK Investigational Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
GSK Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
GSK Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
GSK Investigational Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
GSK Investigational Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
GSK Investigational Site
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
GSK Investigational Site
City
Aviano (PN)
State/Province
Friuli-Venezia-Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
GSK Investigational Site
City
Monza (MB)
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
GSK Investigational Site
City
Macerata
State/Province
Marche
ZIP/Postal Code
62100
Country
Italy
Facility Name
GSK Investigational Site
City
Torrette Di Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Facility Name
GSK Investigational Site
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
GSK Investigational Site
City
Brindisi
State/Province
Puglia
ZIP/Postal Code
72100
Country
Italy
Facility Name
GSK Investigational Site
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95122
Country
Italy
Facility Name
GSK Investigational Site
City
Negrar (Verona)
State/Province
Veneto
ZIP/Postal Code
37024
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
259-1143
Country
Japan
Facility Name
GSK Investigational Site
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
GSK Investigational Site
City
León, Guanajuato
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66278
Country
Mexico
Facility Name
GSK Investigational Site
City
Ciudad de Mexico
ZIP/Postal Code
04980
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico City
ZIP/Postal Code
CP 14080
Country
Mexico
Facility Name
GSK Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Drammen
ZIP/Postal Code
N-3004
Country
Norway
Facility Name
GSK Investigational Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-514
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
GSK Investigational Site
City
Rzeszow
ZIP/Postal Code
35-021
Country
Poland
Facility Name
GSK Investigational Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
GSK Investigational Site
City
Szczecin
ZIP/Postal Code
70-707
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
GSK Investigational Site
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
GSK Investigational Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
011171
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
020142
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
022343
Country
Romania
Facility Name
GSK Investigational Site
City
Bucuresti
ZIP/Postal Code
021389
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
GSK Investigational Site
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
GSK Investigational Site
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
GSK Investigational Site
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
GSK Investigational Site
City
Otopeni
ZIP/Postal Code
075100
Country
Romania
Facility Name
GSK Investigational Site
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
GSK Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
143422
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St.Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kraaifontein
State/Province
Western Province
ZIP/Postal Code
7570
Country
South Africa
Facility Name
GSK Investigational Site
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
GSK Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
GSK Investigational Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
GSK Investigational Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
GSK Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
GSK Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
GSK Investigational Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
GSK Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Wigan.
ZIP/Postal Code
WN1 2NN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

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

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