Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,837

Participants

Timeline

Start Date

April 22, 2014

Primary Completion Date

March 27, 2020

Study Completion Date

May 28, 2029

Conditions
Breast Cancer
Interventions
DRUG

Olaparib

Patients will be administred olaparib orally twice daily (b.i.d.) 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

Placebo

Patients will be administred matching placebo. Two (2) 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.

Trial Locations (698)

101

Research Site, Reykjavik

333

Research Site, Taoyuan District

407

Research Site, Taichung

1011

Research Site, Lausanne

1070

Research Site, Anderlecht

Research Site, Brussels

1090

Research Site, Vienna

Research Site, Brussels

1122

Research Site, Budapest

1130

Research Site, Vienna

1145

Research Site, Budapest

1160

Research Site, Vienna

1200

Research Site, Brussels

2031

Research Site, Randwick

2139

Research Site, Concord

2250

Research Site, Gosford

2298

Research Site, Waratah

2340

Research Site, Tamworth

2485

Research Site, Tweed Heads

2650

Research Site, Edegem

3000

Research Site, Melbourne

Research Site, Leuven

3010

Research Site, Bern

3144

Research Site, Malvern

3355

Research Site, Wendouree

4000

Research Site, Liège

4010

Research Site, Linz

4020

Research Site, Linz

4066

Research Site, Auchenflower

4101

Research Site, South Brisbane

4600

Research Site, Wels

4814

Research Site, Douglas

4840

Research Site, Vöcklabruck

4910

Research Site, Ried

4915

Research Site, Belfast

5000

Research Site, Córdoba

Research Site, Adelaide

Research Site, Namur

5004

Research Site, Ávila

5020

Research Site, Salzburg

5300

Research Site, La Rioja

5500

Research Site, Mendoza

6000

Research Site, Charleroi

6009

Research Site, Nedlands

6020

Research Site, Innsbruck

6156

Research Site, Perugia

6830

Research Site, Rankweil

7000

Research Site, Hobart

8036

Research Site, Graz

8091

Research Site, Zurich

8160

Research Site, Weiz

8400

Research Site, Ostend

8500

Research Site, Kortrijk

8700

Research Site, Leoben

9300

Research Site, Sankt Veit an der Glan

9500

Research Site, Villach

10003

Research Site, Cáceres

10048

Research Site, Taipei

10117

Research Site, Berlin

10367

Research Site, Berlin

10408

Research Site, Goyang-si

10449

Research Site, Taipei

10601

Research Site, White Plains

11042

Research Site, New Hyde Park

11215

Research Site, Brooklyn

11217

Research Site, Taipei

11490

Research Site, Taipei

12002

Research Site, Castellon

13125

Research Site, Berlin

13273

Research Site, Marseille

13589

Research Site, Berlin

13620

Research Site, Seongnam-si

14004

Research Site, Córdoba

14076

Research Site, Caen

14169

Research Site, Berlin

14642

Research Site, Rochester

14770

Research Site, Brandenburg

15006

Research Site, A Coruña

15025

Research Site, Clairton

15706

Research Site, Santiago de Compostela

17007

Research Site, Girona

17042

Research Site, Lebanon

17325

Research Site, Gettysburg

17522

Research Site, Ephrata

17701

Research Site, Williamsport

17837

Research Site, Lewisburg

18059

Research Site, Rostock

19008

Research Site, Broomall

19096

Research Site, Wynnewood

19301

Research Site, Paoli

19605

Research Site, Reading

19611

Research Site, West Reading

19713

Research Site, Newark

20014

Research Site, San Sebastián

20132

Research Site, Milan

20141

Research Site, Milan

20246

Research Site, Hamburg

20814

Research Site, Bethesda

21047

Research Site, Saronno

21053

Research Site, Castellanza Varese

21100

Research Site, Varese

21202

Research Site, Baltimore

21287

Research Site, Baltimore

21565

Research Site, Incheon

21701

Research Site, Frederick

21702

Research Site, Frederick

22003

Research Site, Annandale

22190

Research Site, Plerin SUR MER

23007

Research Site, Jaén

23116

Research Site, Mechanicsville

24127

Research Site, Bergamo

25030

Research Site, Besançon

25198

Research Site, Lleida

25701

Research Site, Huntington

26101

Research Site, Parkersburg

26506

Research Site, Morgantown

27003

Research Site, Lugo

27100

Research Site, Pavia

27356

Research Site, Rotenburg (Wümme)

28002

Research Site, Albemarle

28007

Research Site, Madrid

28033

Research Site, Madrid

28034

Research Site, Madrid

28040

Research Site, Madrid

28041

Research Site, Madrid

28177

Research Site, Bremen

28209

Research Site, Onkologisch Hämatologische Sch

28223

Research Site, Pozuelo de Alarcón

28791

Research Site, Hendersonville

29010

Research Site, Málaga

29609

Research Site, Brest

30177

Research Site, Hanover

30322

Research Site, Atlanta

30559

Research Site, Hanover

30625

Research Site, Hanover

31008

Research Site, Pamplona

31076

Research Site, Toulouse

31134

Research Site, Hildesheim

31405

Research Site, Savannah

31602

Research Site, Valdosta

31785

Research Site, Hamelin

31904

Research Site, Columbus

32114

Research Site, Daytona Beach

32806

Research Site, Orlando

33000

Research Site, Bordeaux

33098

Research Site, Paderborn

33136

Research Site, Miami

33324

Research Site, Plantation

34117

Research Site, Kassel

34298

Research Site, Montpellier

35042

Research Site, Rennes

35128

Research Site, Padua

36043

Research Site, Fulda

37007

Research Site, Salamanca

37024

Research Site, Nehrar

37045

Research Site, Legnago

38320

Research Site, La Laguna (Tenerife)

38518

Research Site, Gifhorn

39100

Research Site, Bolzano

39576

Research Site, Stendal

40138

Research Site, Bologna

40225

Research Site, Düsseldorf

40235

Research Site, Düsseldorf

40447

Research Site, Taichung

40509

Research Site, Lexington

41009

Research Site, Seville

41013

Research Site, Seville

41124

Research Site, Modena

41404

Research Site, Daegu

43204

Research Site, Reus,Tarragona

43215

Research Site, Columbus

43551

Research Site, Perrysburg

43701

Research Site, Zanesville

44035

Research Site, Elyria

44106

Research Site, Cleveland

44122

Research Site, Beachwood

44129

Research Site, Parma

44130

Research Site, Cleveland

44195

Research Site, Cleveland

44202

Research Site, Nantes

44710

Research Site, Canton

45004

Research Site, Toledo

45136

Research Site, Essen

45147

Research Site, Essen

45415

Research Site, Englewood

45429

Research Site, Dayton

45468

Research Site, Mühlheim An Der Ruhr

45504

Research Site, Springfield

45659

Research Site, Recklinghausen

45840

Research Site, Findlay

46009

Research Site, Valencia

46010

Research Site, Valencia

46202

Research Site, Indianapolis

46236

Research Site, Bottrop

46321

Research Site, Munster

46845

Research Site, Fort Wayne

47923

Research Site, Rimini

48060

Research Site, Port Huron

48073

Research Site, Royal Oak

48149

Research Site, Münster

48341

Research Site, Pontiac

49100

Research Site, Petah Tikva

50006

Research Site, Changhua

50009

Research Site, Zaragoza

50010

Research Site, Ames

50401

Research Site, Mason City

50924

Research Site, Cologne

52074

Research Site, Aachen

52242

Research Site, Iowa City

52403

Research Site, Cedar Rapids

52722

Research Site, Bettendorf

52803

Research Site, Davenport

52807

Research Site, Davenport

53113

Research Site, Bonn

54143

Research Site, Marinette

54303

Research Site, Green Bay

54401

Research Site, Wausau

54449

Research Site, Marshfield

54476

Research Site, Weston

54482

Research Site, Stevens Point

54494

Research Site, Wisconsin Rapids

54548

Research Site, Minocqua

54601

Research Site, La Crosse

54701

Research Site, Eau Claire

54729

Research Site, Chippewa Falls

54848

Research Site, Ladysmith

54868

Research Site, Rice Lake

54937

Research Site, Fond du Lac

55131

Research Site, Mainz Am Rhein

55369

Research Site, Maple Grove

55379

Research Site, Shakopee

56001

Research Site, Mankato

56068

Research Site, Koblenz Am Rhein

56303

Research Site, Saint Cloud

56601

Research Site, Bemidji

57105

Research Site, Sioux Falls

58102

Research Site, Fargo

58201

Research Site, Grand Forks

58452

Research Site, Witten

59020

Research Site, Lille

59100

Research Site, Prato

59187

Research Site, Dechy

59715

Research Site, Bozeman

59901

Research Site, Kalispell

60126

Research Site, Elmhurst

60435

Research Site, Joliet

60608

Research Site, Chicago

60611

Research Site, Chicago

60625

Research Site, Chicago

61114

Research Site, Rockford

63011

Research Site, Clermont-Ferrand

63069

Research Site, Offenbach

63109

Research Site, St Louis

63141

Research Site, St Louis

65807

Research Site, Springfield

65929

Research Site, Frankfurt am Main

66112

Research Site, Kansas City

66113

Research Site, Saarbrücken

66205

Research Site, Fairway

67065

Research Site, Strasbourg

68114

Research Site, Omaha

68124

Research Site, Omaha

68167

Research Site, Mannheim

68506

Research Site, Lincoln

68510

Research Site, Lincoln

68701

Research Site, Norfolk

68803

Research Site, Grand Island

69373

Research Site, Lyon

70065

Research Site, Kenner

70360

Research Site, Los Angeles

70403

Research Site, Tainan City

70458

Research Site, Slidell

70809

Research Site, Baton Rouge

71103

Research Site, Shreveport

71105

Research Site, Shreveport

71202

Research Site, Monroe

72076

Research Site, Tübingen

73100

Research Site, Lecce

73657

Research Site, Tainan City

73730

Research Site, Esslingen am Neckar

75010

Research Site, Paris

76038

Research Site, Rouen

76135

Research Site, Karlsruhe

76532

Research Site, Baden-Baden

77030

Research Site, Houston

78665

Research Site, Round Rock

79106

Research Site, Freiburg im Breisgau

79415

Research Site, Lubbock

79430

Research Site, Lubbock

80026

Research Site, Lafayette

80045

Research Site, Aurora

80124

Research Site, Lone Tree

80131

Research Site, Napoli

80205

Research Site, Denver

80337

Research Site, München

80634

Research Site, München

80756

Research Site, Kaohsiung City

80907

Research Site, Colorado Springs

81675

Research Site, München

83814

Research Site, Coeur d'Alene

83854

Research Site, Post Falls

84307

Research Site, Eggenfelden

84403

Research Site, Ogden

84918

Research Site, Avignon

85025

Research Site, La Roche-sur-Yon

85234

Research Site, Gilbert

85560

Research Site, Ebersberg

86150

Research Site, Augsburg

87042

Research Site, Limoges

87102

Research Site, Albuquerque

87700

Research Site, Memmingen

88212

Research Site, Ravensburg

89075

Research Site, Ulm

90027

Research Site, Los Angeles

90033

Research Site, Los Angeles

90146

Research Site, Palermo

90185

Research Site, Umeå

90766

Research Site, Fürth

91010

Research Site, Duarte

91054

Research Site, Erlangen

91120

Research Site, Jerusalem

92078

Research Site, San Marcos

92211

Research Site, Saint-Cloud

92335

Research Site, Fontana

92663

Research Site, Newport Beach

94086

Research Site, Sunnyvale

94115

Research Site, San Francisco

94469

Research Site, Deggendorf

94577

Research Site, San Leandro

94589

Research Site, Vallejo

94611

Research Site, Oakland

94704

Research Site, Berkeley

94805

Research Site, Villejuif

94904

Research Site, Greenbrae

95403

Research Site, Santa Rosa

95661

Research Site, Roseville

95688

Research Site, Vacaville

97421

Research Site, Schweinfurt

98034

Research Site, Kirkland

98109

Research Site, Seattle

98370

Research Site, Poulsbo

98531

Research Site, Centralia

99085

Research Site, Erfurt

99336

Research Site, Kennewick

99508

Research Site, Anchorage

Research Site, Anchorage

99734

Research Site, Nordhausen

99974

Research Site, Mühlhausen

100006

Research Site, Beijing

100021

Research Site, Beijing

100730

Research Site, Beijing

130061

Research Site, Changchun

150081

Research Site, Harbin

200025

Research Site, Shanghai

200032

Research Site, Shanghai

210029

Research Site, Nanjing

250117

Research Site, Jinan

300060

Research Site, Tianjin

310003

Research Site, Hangzhou

310022

Research Site, Hangzhou

350001

Research Site, Fuzhou

510100

Research Site, Guangzhou

610041

Research Site, Chengdu

5265601

Research Site, Ramat Gan

6423906

Research Site, Tel Aviv

Unknown

Research Site, Fort Smith

Research Site, Baldwin Park

Research Site, Fresno

Research Site, Los Angeles

Research Site, Martinez

Research Site, Palo Alto

Research Site, Paradise

Research Site, Roseville

Research Site, San Jose

Research Site, Santa Cruz

Research Site, South San Francisco

Research Site, Stockton

Research Site, Sunnyvale

Research Site, Woodland Hills

Research Site, Edwards

Research Site, Fort Collins

Research Site, Derby

Research Site, Fairfield

Research Site, Guilford

Research Site, New Haven

Research Site, North Haven

Research Site, Orange

Research Site, Torrington

Research Site, Trumbull

Research Site, Waterbury

Research Site, Newark

Research Site, Washington D.C.

Research Site, Deerfield Beach

Research Site, Gainesville

Research Site, Decatur

Research Site, Macon

Research Site, Honolulu

Research Site, Kuakini

Research Site, ‘Aiea

Research Site, Boise

Research Site, Fruitland

Research Site, Meridian

Research Site, Nampa

Research Site, Twin Falls

Research Site, Centralia

Research Site, Chicago

Research Site, Decatur

Research Site, Effingham

Research Site, Evanston

Research Site, Glenview

Research Site, Highland Park

Research Site, Maywood

Research Site, Mount Vernon

Research Site, Peoria

Research Site, Warrenville

Research Site, Elkhart

Research Site, Fort Wayne

Research Site, Indianapolis

Research Site, Mishawaka

Research Site, Muncie

Research Site, Munster

Research Site, Plymouth

Research Site, South Bend

Research Site, Westville

Research Site, Ames

Research Site, Iowa City

Research Site, Mason City

Research Site, Chanute

Research Site, El Dorado

Research Site, Garden City

Research Site, Hays

Research Site, Kansas City

Research Site, Lawrence

Research Site, Newton

Research Site, Olathe

Research Site, Salina

Research Site, Topeka

Research Site, Wichita

Research Site, Winfield

Research Site, Louisville

Research Site, Baton Rouge

Research Site, Covington

Research Site, Houma

Research Site, New Orleans

Research Site, Bangor

Research Site, Portland

Research Site, Rockport

Research Site, Baltimore

Research Site, Easton

Research Site, Frederick

Research Site, Boston

Research Site, Pittsfield

Research Site, Springfield

Research Site, Ann Arbor

Research Site, Detroit

Research Site, Flint

Research Site, Grand Rapids

Research Site, Jackson

Research Site, Kalamazoo

Research Site, Muskegon

Research Site, Royal Oak

Research Site, Saint Joseph

Research Site, Southfield

Research Site, Traverse City

Research Site, Troy

Research Site, Warren

Research Site, Burnsville

Research Site, Duluth

Research Site, Edina

Research Site, Fridley

Research Site, Maplewood

Research Site, Minneapolis

Research Site, Rochester

Research Site, Saint Louis Park

Research Site, Saint Paul

Research Site, Waconia

Research Site, Woodbury

Research Site, Jackson

Research Site, Cape Girardeau

Research Site, Joplin

Research Site, Kansas City

Research Site, Lee's Summit

Research Site, Springfield

Research Site, St Louis

Research Site, Omaha

Research Site, Hamilton

Research Site, Mount Holly

Research Site, New Brunswick

Research Site, Voorhees Township

Research Site, Albuquerque

Research Site, Charlotte

Research Site, East Syracuse

Research Site, New York

Research Site, The Bronx

Research Site, Asheville

Research Site, Charlotte

Research Site, Clinton

Research Site, Concord

Research Site, Durham

Research Site, Gastonia

Research Site, Goldsboro

Research Site, Greensboro

Research Site, Hendersonville

Research Site, Jacksonville

Research Site, Kinston

Research Site, Pinehurst

Research Site, Wilson

Research Site, Winston-Salem

Research Site, Minot

Research Site, Akron

Research Site, Columbus

Research Site, Dayton

Research Site, Maumee

Research Site, Oregon

Research Site, Sylvania

Research Site, Toledo

Research Site, Oklahoma City

Research Site, Tulsa

Research Site, Portland

Research Site, Abington

Research Site, Bryn Mawr

Research Site, Danville

Research Site, Drexel Hill

Research Site, Harrisburg

Research Site, Hazleton

Research Site, Hershey

Research Site, Media

Research Site, Paoli

Research Site, Philadelphia

Research Site, Phoenixville

Research Site, Pittsburgh

Research Site, State College

Research Site, West Reading

Research Site, Wilkes-Barre

Research Site, Williamsport

Research Site, York

Research Site, Anderson

Research Site, Charleston

Research Site, Greenville

Research Site, Greenwood

Research Site, Greer

Research Site, Seneca

Research Site, Spartanburg

Research Site, Lubbock

Research Site, Temple

Research Site, American Fork

Research Site, Murray

Research Site, Provo

Research Site, St. George

Research Site, Berlin Corners

Research Site, Burlington

Research Site, Fairfax

Research Site, Fredericksburg

Research Site, Lynchburg

Research Site, Midlothian

Research Site, Richmond

Research Site, South Hill

Research Site, Seattle

Research Site, Charleston

Research Site, Burlington

Research Site, Elkhorn

Research Site, Grafton

Research Site, Green Bay

Research Site, Kenosha

Research Site, Menomonee Falls

Research Site, Milwaukee

Research Site, Mukwonago

Research Site, Oconomowoc

Research Site, Summit

Research Site, Waukesha

Research Site, Wauwatosa

Research Site, West Allis

Research Site, Marseille

95816-5680

Research Site, Sacramento

04330

Research Site, Augusta

04005

Research Site, Biddeford

04073

Research Site, Sanford

04074

Research Site, Scarborough

03756

Research Site, Lebanon

03102

Research Site, Manchester

03063

Research Site, Nashua

08822

Research Site, Flemington

07960

Research Site, Morristown

54311-6519

Research Site, Green Bay

B1884BBF

Research Site, Berazategui

C1125ABD

Research Site, Buenos Aires

C1426ANZ

Research Site, CABA

X5002AOQ

Research Site, Córdoba

S2000KZE

Research Site, Rosario

T4000IAK

Research Site, San Miguel de Tucumán

S3000FFU

Research Site, Santa Fe

T6G 1Z2

Research Site, Edmonton

V5Z 4E6

Research Site, Vancouver

R3E 0V9

Research Site, Winnipeg

L8V 5C2

Research Site, Hamilton

M4N 3M5

Research Site, Toronto

J4V 2H1

Research Site, Greenfield Park

H2W 1T8

Research Site, Montreal

H3T 1E2

Research Site, Montreal

G1S 4L8

Research Site, Québec

S4T 7T1

Research Site, Regina

S7N 4H4

Research Site, Saskatoon

050020

Research Site, Shijiazhuang

06100

Research Site, Nice

09116

Research Site, Chemnitz

01307

Research Site, Dresden

07548

Research Site, Gera

06120

Research Site, Halle

04103

Research Site, Leipzig

01100

Research Site, Viterbo

260-8717

Research Site, Chiba

104-0045

Research Site, Chūōku

104-8560

Research Site, Chūōku

811-1395

Research Site, Fukuoka

350-1298

Research Site, Hidaka-shi

730-8518

Research Site, Hiroshima

259-1193

Research Site, Isehara-shi

892-0833

Research Site, Kagoshima

277-8577

Research Site, Kashiwa

216-8511

Research Site, Kawasaki-shi

135-8550

Research Site, Kōtoku

606-8507

Research Site, Kyoto

791-0280

Research Site, Matsuyama

028-3695

Research Site, Morioka

464-8681

Research Site, Nagoya

467-8602

Research Site, Nagoya

783-8505

Research Site, Nankoku-shi

951-8566

Research Site, Niigata

540-0006

Research Site, Osaka

541-8567

Research Site, Osaka

373-8550

Research Site, Ota-shi

003-0804

Research Site, Sapporo

142-8666

Research Site, Shinagawa-ku

411-8777

Research Site, Shizuoka

565-0871

Research Site, Suita

1066 CX

Research Site, Amsterdam

4819 EV

Research Site, Breda

6162 BG

Research Site, Geleen

2333 ZA

Research Site, Leiden

6202 AZ

Research Site, Maastricht

3015 GD

Research Site, Rotterdam

1502 DV

Research Site, Zaandam

80-214

Research Site, Gdansk

72-003

Research Site, Grzepnica

93-338

Research Site, Lodz

10-228

Research Site, Olsztyn

60-693

Research Site, Poznan

01-748

Research Site, Warsaw

02-781

Research Site, Warsaw

1099-023

Research Site, Lisbon

1400-038

Research Site, Lisbon

1500-650

Research Site, Lisbon

1998-018

Research Site, Lisbon

2674-514

Research Site, Loures

4200-072

Research Site, Porto

00936

Research Site, San Juan

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

07985

Research Site, Seoul

06008

Research Site, Badajoz

08916

Research Site, Badalona

08025

Research Site, Barcelona

08028

Research Site, Barcelona

08035

Research Site, Barcelona

03202

Research Site, Elche(Alicante)

08907

Research Site, Hosp de Llobregat(Barcelona)

07010

Research Site, Palma de Mallorca

08208

Research Site, Sabadell(Barcelona)

08227

Research Site, Terrassa(Barcelona)

413 45

Research Site, Gothenburg

581 85

Research Site, Linköping

221 85

Research Site, Lund

171 64

Research Site, Solna

118 83

Research Site, Stockholm

BT9 7AB

Research Site, Belfast

B15 2TH

Research Site, Birmingham

BH7 7DW

Research Site, Bournemouth

BS2 8ED

Research Site, Bristol

CB2 0QQ

Research Site, Cambridge

CF14 2TL

Research Site, Cardiff

DY1 2HQ

Research Site, Dudley

EH4 2XR

Research Site, Edinburgh

G12 0YN

Research Site, Glasgow

LS9 7TF

Research Site, Leeds

E1 1BB

Research Site, London

NW1 2PG

Research Site, London

SE1 9RT

Research Site, London

SW17 0QT

Research Site, London

SW3 6JJ

Research Site, London

M20 4GJ

Research Site, Manchester

NG5 1PB

Research Site, Nottingham

OX3 7LE

Research Site, Oxford

S10 2SJ

Research Site, Sheffield

SO16 6YD

Research Site, Southampton

ST4 6QG

Research Site, Stoke-on-Trent

SM2 5PT

Research Site, Sutton

Sponsors
All Listed Sponsors
collaborator

Breast International Group

OTHER

collaborator

Frontier Science & Technology Research Foundation, Inc.

INDUSTRY

collaborator

NRG Oncology

OTHER

collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

collaborator

The Breast Adjuvant Study Team

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY