Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

March 27, 2014

Primary Completion Date

December 9, 2016

Study Completion Date

December 31, 2025

Conditions
Breast Cancer MetastaticBRCA 1 Gene MutationBRCA 2 Gene Mutation
Interventions
DRUG

Olaparib

Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

DRUG

Physician's choice chemotherapy

"Investigators will declare one of the following regimens:~* Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days~* Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days~* Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days"

Trial Locations (171)

333

Research Site, Taoyuan District

407

Research Site, Taichung

1032

Research Site, Budapest

1083

Research Site, Budapest

1115

Research Site, Budapest

1122

Research Site, Budapest

1145

Research Site, Budapest

1233

Research Site, Sofia

1260

Research Site, Adana

1303

Research Site, Sofia

1330

Research Site, Sofia

1504

Research Site, Sofia

3000

Research Site, Vratsa

4000

Research Site, Plovdiv

4004

Research Site, Plovdiv

4400

Research Site, Nyíregyháza

6351

Research Site, Seoul

6760

Research Site, México

8063

Research Site, Zurich

8200

Research Site, Veszprém

9010

Research Site, Varna

10021

Research Site, New York

10048

Research Site, Taipei

10065

Research Site, New York

10449

Research Site, Taipei

10604

Research Site, Harrison

11217

Research Site, Taipei

11570

Research Site, Rockville Centre

11725

Research Site, Commack

13210

Research Site, Syracuse

13620

Research Site, Seongnam-si

14004

Research Site, Córdoba

14076

Research Site, Caen

18014

Research Site, Granada

18840

Research Site, Sayre

19104

Research Site, Philadelphia

20007

Research Site, Washington D.C.

20089

Research Site, Rozzano

21565

Research Site, Incheon

22030

Research Site, Edirne

27310

Research Site, Gaziantep

28034

Research Site, Madrid

28222

Research Site, Majadahonda

28644

Research Site, Cheongju-si

30060

Research Site, Marietta

31904

Research Site, Columbus

32224

Research Site, Jacksonville

32804

Research Site, Orlando

33011

Research Site, Oviedo

33110

Research Site, Mersin

33324

Research Site, Plantation

34298

Research Site, Montpellier

34390

Research Site, Istanbul

35100

Research Site, Izmir

35128

Research Site, Padua

38039

Research Site, Kayseri

38138

Research Site, Germantown

39202

Research Site, Jackson

40138

Research Site, Bologna

41013

Research Site, Seville

41404

Research Site, Daegu

42080

Research Site, Konya

44106

Research Site, Cleveland

44195

Research Site, Cleveland

45267

Research Site, Cincinnati

46026

Research Site, Valencia

48201

Research Site, Detroit

49503

Research Site, Grand Rapids

50009

Research Site, Zaragoza

50080

Research Site, Estado de México

55416

Research Site, Saint Louis Park

60612

Research Site, Chicago

60714

Research Site, Niles

63131

Research Site, St Louis

65212

Research Site, Columbia

67065

Research Site, Strasbourg

67214

Research Site, Wichita

70506

Research Site, Lafayette

75701

Research Site, Tyler

76038

Research Site, Rouen

76800

Research Site, San Juan del Río

77030

Research Site, Houston

80131

Research Site, Napoli

80204

Research Site, Denver

80756

Research Site, Kaohsiung City

90602

Research Site, Whittier

92123

Research Site, San Diego

94800

Research Site, Villejuif

95403

Research Site, Santa Rosa

97000

Research Site, Mérida

97070

Research Site, Mérida

97133

Research Site, Mérida

97213

Research Site, Portland

100006

Research Site, Beijing

100021

Research Site, Beijing

100142

Research Site, Beijing

110016

Research Site, Shenyang

115478

Research Site, Moscow

116011

Research Site, Dalian

130061

Research Site, Changchun

150054

Research Site, Yaroslavl

150081

Research Site, Harbin

153040

Research Site, Ivanovo

163045

Research Site, Arkhangelsk

191014

Research Site, Saint Petersburg

195257

Research Site, Saint Petersburg

195271

Research Site, Saint Petersburg

197022

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

200025

Research Site, Shanghai

200032

Research Site, Shanghai

210009

Research Site, Nanjing

300060

Research Site, Tianjin

310022

Research Site, Hangzhou

400015

Research Site, Cluj-Napoca

410013

Research Site, Changsha

430005

Research Site, Saransk

510060

Research Site, Guangzhou

610041

Research Site, Chengdu

644013

Research Site, Omsk

06510

Research Site, New Haven

02114

Research Site, Boston

02118

Research Site, Boston

02215

Research Site, Boston

55905-0001

Research Site, Rochester

03756

Research Site, Lebanon

05401

Research Site, Burlington

656 53

Research Site, Brno

775 20

Research Site, Olomouc

128 08

Research Site, Prague

00144

Research Site, Roma

00168

Research Site, Roma

104-0045

Research Site, Chūōku

104-8560

Research Site, Chūōku

811-1395

Research Site, Fukuoka

892-0833

Research Site, Kagoshima

464-8681

Research Site, Nagoya

540-0006

Research Site, Osaka

003-0804

Research Site, Sapporo

142-8666

Research Site, Shinagawa-ku

565-0871

Research Site, Suita

CUSCO 01

Research Site, Cusco

LIMA 01

Research Site, Lima

Lima 18

Research Site, Lima

LIMA 27

Research Site, Lima

LIMA 34

Research Site, Lima

LIMA 41

Research Site, Lima

Research Site, San Borja

82-300

Research Site, Elblag

80-952

Research Site, Gdansk

72-003

Research Site, Grzepnica

93-513

Research Site, Lodz

39-400

Research Site, Tarnobrzeg

01-748

Research Site, Warsaw

03-291

Research Site, Warsaw

011171

Research Site, Bucharest

013811

Research Site, Bucharest

030171

Research Site, Bucharest

03080

Research Site, Seoul

03722

Research Site, Seoul

158-710

Research Site, Seoul

08003

Research Site, Barcelona

CH-3010

Research Site, Bern

CH-1011

Research Site, Lausanne

06230

Research Site, Ankara

AB25 2ZN

Research Site, Aberdeen

CO4 5JL

Research Site, Colchester

CV2 2DX

Research Site, Coventry

W6 8RF

Research Site, London

M20 4BX

Research Site, Manchester

PL6 8DH.

Research Site, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY