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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 28, 2021

Primary Completion Date

June 28, 2024

Study Completion Date

December 31, 2025

Conditions
Neoplasms, Breast
Interventions
DRUG

Niraparib

Niraparib will be administered.

DRUG

Placebo

Matching placebo will be administered

Trial Locations (198)

8

GSK Investigational Site, Dublin

9

GSK Investigational Site, Dublin

1070

GSK Investigational Site, Brussels

1200

GSK Investigational Site, Brussels

2050

GSK Investigational Site, Camperdown

2060

GSK Investigational Site, North Sydney

2109

GSK Investigational Site, Macquarie Park

2822

GSK Investigational Site, Entre Ríos

3000

GSK Investigational Site, Leuven

4011

GSK Investigational Site, Stavanger

4031

GSK Investigational Site, Basel

4032

GSK Investigational Site, Debrecen

4400

GSK Investigational Site, Steyr

6000

GSK Investigational Site, Charleroi

6020

GSK Investigational Site, Innsbruck

6045

GSK Investigational Site, Port Elizabeth

7700

GSK Investigational Site, Cape Town

9000

GSK Investigational Site, Ghent

10003

GSK Investigational Site, Cáceres

10032

GSK Investigational Site, New York

10060

GSK Investigational Site, Candiolo to

13125

GSK Investigational Site, Berlin

13915

GSK Investigational Site, Marseille

14000

GSK Investigational Site, Caen

14004

GSK Investigational Site, Córdoba

15213

GSK Investigational Site, Pittsburgh

15706

GSK Investigational Site, Santiago de Compostela

16132

GSK Investigational Site, Genova

18016

GSK Investigational Site, Granada

19111

GSK Investigational Site, Philadelphia

20141

GSK Investigational Site, Milan

20157

GSK Investigational Site, Milan

20520

GSK Investigational Site, Turku

20900

GSK Investigational Site, Monza

21000

GSK Investigational Site, Dijon

23502

GSK Investigational Site, Norfolk

28034

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28050

GSK Investigational Site, Madrid

29010

GSK Investigational Site, Málaga

31096

GSK Investigational Site, Haifa

33076

GSK Investigational Site, Bordeaux

34070

GSK Investigational Site, Montpellier

35128

GSK Investigational Site, Padua

37024

GSK Investigational Site, Negrar Verona

37178

GSK Investigational Site, León

40138

GSK Investigational Site, Bologna

45136

GSK Investigational Site, Essen

46010

GSK Investigational Site, Valencia

47014

GSK Investigational Site, Meldola FC

48109

GSK Investigational Site, Ann Arbor

49100

GSK Investigational Site, Petah Tikva

50009

GSK Investigational Site, Zaragoza

50935

GSK Investigational Site, Cologne

57104

GSK Investigational Site, Sioux Falls

58122

GSK Investigational Site, Fargo

60076

GSK Investigational Site, Skokie

60126

GSK Investigational Site, Ancona

60612

GSK Investigational Site, Chicago

62100

GSK Investigational Site, Ancona

64239

GSK Investigational Site, Tel Aviv

64460

GSK Investigational Site, Monterrey

66278

GSK Investigational Site, Monterrey

68167

GSK Investigational Site, Mannheim

69495

GSK Investigational Site, Pierre-Bénite

72100

GSK Investigational Site, Brindisi

75231

GSK Investigational Site, Dallas

75246

GSK Investigational Site, Dallas

75702

GSK Investigational Site, Tyler

76000

GSK Investigational Site, Rouen

76100

GSK Investigational Site, Rehovot

76104

GSK Investigational Site, Fort Worth

77024

GSK Investigational Site, Houston

78240

GSK Investigational Site, San Antonio

78731

GSK Investigational Site, Austin

80045

GSK Investigational Site, Aurora

GSK Investigational Site, Highlands Ranch

80131

GSK Investigational Site, Napoli

81377

GSK Investigational Site, München

84101

GSK Investigational Site, Beersheba

84918

GSK Investigational Site, Avignon

87106

GSK Investigational Site, Albuquerque

89075

GSK Investigational Site, Ulm

91010

GSK Investigational Site, Duarte

91031

GSK Investigational Site, Jerusalem

91054

GSK Investigational Site, Erlangen

91120

GSK Investigational Site, Jerusalem

91505

GSK Investigational Site, Burbank

92210

GSK Investigational Site, Saint-Cloud

94158

GSK Investigational Site, San Francisco

94304

GSK Investigational Site, Palo Alto

95122

GSK Investigational Site, Catania

98201

GSK Investigational Site, Everett

111123

GSK Investigational Site, Moscow

121309

GSK Investigational Site, Moscow

143422

GSK Investigational Site, Moscow

196603

GSK Investigational Site, Pushkin

197022

GSK Investigational Site, StPetersburg

197110

GSK Investigational Site, Saint Petersburg

197758

GSK Investigational Site, Saint Petersburg

200347

GSK Investigational Site, Craiova

300239

GSK Investigational Site, Timișoara

400015

GSK Investigational Site, Cluj-Napoca

454048

GSK Investigational Site, Chelyabinsk

644013

GSK Investigational Site, Omsk

5360000

GSK Investigational Site, Temuco

7500653

GSK Investigational Site, Santiago

7500836

GSK Investigational Site, Santiago

90610000

GSK Investigational Site, Porto Alegre

C1017 AAS

GSK Investigational Site, Buenos Aires

C1125ABD

GSK Investigational Site, Buenos Aires

C1426ABP

GSK Investigational Site, Buenos Aires

C1426ANZ

GSK Investigational Site, Capital Federal

R8324CVE

GSK Investigational Site, Cipoletti Rio Negro

C1430EGF

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1015ABO

GSK Investigational Site, Ciudad AutOnoma de Buenos Aire

C1426AGE

GSK Investigational Site, Ciudad Autonoma de Buenos Aire

C1118AAT

GSK Investigational Site, Ciudad de Buenos Aires

A-6830

GSK Investigational Site, Feldkirch

A-1090

GSK Investigational Site, Vienna

30130-100

GSK Investigational Site, Belo Horizonte

88034-000

GSK Investigational Site, Florianópolis

90020-090

GSK Investigational Site, Porto Alegre

20560-120

GSK Investigational Site, Rio de Janeiro

95070-560

GSK Investigational Site, Rio Grande

40170-110

GSK Investigational Site, Salvador

01317000

GSK Investigational Site, São Paulo

04312903

GSK Investigational Site, São Paulo

29043-260

GSK Investigational Site, Vitória

T2N 4N2

GSK Investigational Site, Calgary

M4N 3M5

GSK Investigational Site, Toronto

M5G 2M9

GSK Investigational Site, Toronto

H3T 1E2

GSK Investigational Site, Montreal

G1S 4L8

GSK Investigational Site, Québec

00180

GSK Investigational Site, Helsinki

HUS 00029

GSK Investigational Site, Helsinki

464-8681

GSK Investigational Site, Aichi

277-8577

GSK Investigational Site, Chiba

791-0280

GSK Investigational Site, Ehime

811-1395

GSK Investigational Site, Fukuoka

730-8518

GSK Investigational Site, Hiroshima

003-0804

GSK Investigational Site, Hokkaido

892-0833

GSK Investigational Site, Kagoshima

216-8511

GSK Investigational Site, Kanagawa

241-8515

GSK Investigational Site, Kanagawa

259-1143

GSK Investigational Site, Kanagawa

700-8558

GSK Investigational Site, Okayama

541-8567

GSK Investigational Site, Osaka

589-8511

GSK Investigational Site, Osaka

350-1298

GSK Investigational Site, Saitama

350-8550

GSK Investigational Site, Saitama

362-0806

GSK Investigational Site, Saitama

104-0045

GSK Investigational Site, Tokyo

113-8431

GSK Investigational Site, Tokyo

135-8550

GSK Investigational Site, Tokyo

142-8666

GSK Investigational Site, Tokyo

04980

GSK Investigational Site, Mexico City

1815 JD

GSK Investigational Site, Alkmaar

8934 AD

GSK Investigational Site, Leeuwarden

6229 HX

GSK Investigational Site, Maastricht

3083 AN

GSK Investigational Site, Rotterdam

2545 AA

GSK Investigational Site, The Hague

8025 AB

GSK Investigational Site, Zwolle

N-3004

GSK Investigational Site, Drammen

40-514

GSK Investigational Site, Katowice

31-115

GSK Investigational Site, Krakow

31-501

GSK Investigational Site, Krakow

10-228

GSK Investigational Site, Olsztyn

61-866

GSK Investigational Site, Poznan

35-021

GSK Investigational Site, Rzeszów

08-110

GSK Investigational Site, Siedlce

70-707

GSK Investigational Site, Szczecin

02-781

GSK Investigational Site, Warsaw

53-413

GSK Investigational Site, Wroclaw

1649-035

GSK Investigational Site, Lisbon

2674-514

GSK Investigational Site, Loures

011171

GSK Investigational Site, Bucharest

020142

GSK Investigational Site, Bucharest

021389

GSK Investigational Site, Bucharest

022343

GSK Investigational Site, Bucharest

075100

GSK Investigational Site, Otopeni

0041

GSK Investigational Site, Pretoria

08003

GSK Investigational Site, Barcelona

08028

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

BA1 3NG

GSK Investigational Site, Bath

BN2 5BE

GSK Investigational Site, Brighton

CF14 2TL

GSK Investigational Site, Cardiff

CV2 2DX

GSK Investigational Site, Coventry

EH4 2XU

GSK Investigational Site, Edinburgh

LS9 7TF

GSK Investigational Site, Leeds

SE1 9RT

GSK Investigational Site, London

SW3 6JJ

GSK Investigational Site, London

ME16 9QQ

GSK Investigational Site, Maidstone

M20 4BX

GSK Investigational Site, Manchester

SM2 5PT

GSK Investigational Site, Sutton

WN1 2NN

GSK Investigational Site, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04915755 - 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 | Biotech Hunter | Biotech Hunter