A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

PHASE3TerminatedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

February 25, 2014

Primary Completion Date

May 23, 2018

Study Completion Date

October 26, 2021

Conditions
Neoplasms, BreastCarcinoma of BreastHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastBRCA1 Gene MutationBRCA2 Gene MutationOvarian Neoplasms
Interventions
DRUG

niraparib

300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops

DRUG

Physician's choice

Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops

Trial Locations (104)

1000

GSK Investigational Site, Brussels

1122

GSK Investigational Site, Budapest

1200

GSK Investigational Site, Brussels

2650

GSK Investigational Site, Edegem

3501

GSK Investigational Site, Miskolc

4000

GSK Investigational Site, Liège

4032

GSK Investigational Site, Debrecen

4400

GSK Investigational Site, Nyíregyháza

5000

GSK Investigational Site, Namur

6720

GSK Investigational Site, Szeged

7624

GSK Investigational Site, Pécs

8035

GSK Investigational Site, Barcelona

8907

GSK Investigational Site, L'Hospitalet de Llobregat

9300

GSK Investigational Site, Aalst

10003

GSK Investigational Site, Cáceres

11042

GSK Investigational Site, Lake Success

12065

GSK Investigational Site, Clifton Park

14564

GSK Investigational Site, Nea Kifissia

15123

GSK Investigational Site, Marousi

16132

GSK Investigational Site, Genoa

18547

GSK Investigational Site, Neo Faliro

19111

GSK Investigational Site, Philadelphia

20141

GSK Investigational Site, Milan

21079

GSK Investigational Site, Dijon

24457

GSK Investigational Site, Low Moor

25198

GSK Investigational Site, Lleida

26100

GSK Investigational Site, Cremona

27003

GSK Investigational Site, Lugo

28041

GSK Investigational Site, Madrid

31008

GSK Investigational Site, Pamplona

33076

GSK Investigational Site, Bordeaux

33176

GSK Investigational Site, Miami

33901

GSK Investigational Site, Fort Myers

34298

GSK Investigational Site, Montpellier

36312

GSK Investigational Site, Vigo

37045

GSK Investigational Site, Legnago (VR)

37203

GSK Investigational Site, Nashville

37232

GSK Investigational Site, Nashville

43100

GSK Investigational Site, Parma

44195

GSK Investigational Site, Cleveland

44202

GSK Investigational Site, Nantes

44281

GSK Investigational Site, Kfar Saba

46009

GSK Investigational Site, Valencia

46015

GSK Investigational Site, Valencia

47014

GSK Investigational Site, Meldola (FC)

47900

GSK Investigational Site, Rimini

52621

GSK Investigational Site, Tel Litwinsky

54311

GSK Investigational Site, Green Bay

57001

GSK Investigational Site, Thessaloniki

58100

GSK Investigational Site, Holon

59020

GSK Investigational Site, Lille

59100

GSK Investigational Site, Prato

60020

GSK Investigational Site, Ancona

68114

GSK Investigational Site, Omaha

69373

GSK Investigational Site, Lyon

71110

GSK Investigational Site, Heraklion,Crete

73100

GSK Investigational Site, Lecce

75237

GSK Investigational Site, Dallas

75248

GSK Investigational Site, Paris

76100

GSK Investigational Site, Rehovot

76104

GSK Investigational Site, Fort Worth

77598

GSK Investigational Site, Webster

78217

GSK Investigational Site, San Antonio

78596

GSK Investigational Site, Weslaco

85710

GSK Investigational Site, Tucson

89074

GSK Investigational Site, Henderson

90033

GSK Investigational Site, Los Angeles

90048

GSK Investigational Site, Los Angeles

92210

GSK Investigational Site, Saint-Cloud

97225

GSK Investigational Site, Portland

97401

GSK Investigational Site, Eugene

98111

GSK Investigational Site, Seattle

98201

GSK Investigational Site, Everett

3109601

GSK Investigational Site, Haifa

6423906

GSK Investigational Site, Tel Aviv

02111

GSK Investigational Site, Boston

T2N 4N2

GSK Investigational Site, Calgary

V1Y 5L3

GSK Investigational Site, Kelowna

M5G 2M9

GSK Investigational Site, Toronto

H2L 4M1

GSK Investigational Site, Montreal

IS-101

GSK Investigational Site, Reykjavik

01100

GSK Investigational Site, Viterbo

2333 ZA

GSK Investigational Site, Leiden, RC

6229HX

GSK Investigational Site, Limburg

8025 AB

GSK Investigational Site, Zwolle

93-513

GSK Investigational Site, Lodz

47-400

GSK Investigational Site, Racibórz

3000-075

GSK Investigational Site, Coimbra

1400-038

GSK Investigational Site, Lisbon

4200-072

GSK Investigational Site, Porto

09005

GSK Investigational Site, Burgos

SO16 6YD

GSK Investigational Site, Southampton

HA6 2RN

GSK Investigational Site, Northwood

OX3 7LJ

GSK Investigational Site, Headington, Oxford

SM2 5PT

GSK Investigational Site, Sutton

CH63 4JY

GSK Investigational Site, Bebington, Wirral

BT9 7AB

GSK Investigational Site, Belfast

EH4 2XU

GSK Investigational Site, Edinburgh

G11 6NT

GSK Investigational Site, Glasgow

NW1 2PG

GSK Investigational Site, London

SE1 9RT

GSK Investigational Site, London

SW3 6JJ

GSK Investigational Site, London

NG5 1PB

GSK Investigational Site, Nottingham

CF14 2TL

GSK Investigational Site, Whitchurch, Cardiff

Sponsors
All Listed Sponsors
collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

collaborator

Breast International Group

OTHER

collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

collaborator

US Oncology Research

INDUSTRY

collaborator

Sarah Cannon

INDUSTRY

collaborator

Facing Our Risk of Cancer Empowered

OTHER

lead

Tesaro, Inc.

INDUSTRY

NCT01905592 - A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients | Biotech Hunter | Biotech Hunter