A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,370

Participants

Timeline

Start Date

January 28, 2021

Primary Completion Date

August 24, 2026

Study Completion Date

February 1, 2029

Conditions
ER-Positive HER2-Negative Breast Cancer
Interventions
DRUG

AZD9833

Dosage formulation: AZD9833 tablets will be administered orally

DRUG

Anastrozole

Dosage formulation: Anastrozole tablets will be administered orally.

DRUG

Anastrozole placebo

Dosage formulation: anastrozole placebo tablets will be administrated orally.

DRUG

AZD9833 placebo

Dosage formulation: AZD9833 placebo tablets will be administrated orally.

DRUG

Palbociclib

Dosage formulation: palbociclib tablets/capsules will be administered orally

DRUG

Luteinizing hormone-releasing hormone (LHRH) agonist

Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.

Trial Locations (263)

104

Research Site, Taipei

110

Research Site, Taipei

161

Research Site, Roma

235

Research Site, Taipei

333

Research Site, Taoyuan District

1062

Research Site, Budapest

1070

Research Site, Anderlecht

1088

Research Site, Budapest

1122

Research Site, Budapest

1130

Research Site, Vienna

1330

Research Site, Sofia

1431

Research Site, Sofia

1527

Research Site, Sofia

2650

Research Site, Edegem

3000

Research Site, Leuven

3004

Research Site, Drammen

3526

Research Site, Miskolc

4000

Research Site, Liège

Research Site, Plovdiv

4109

Research Site, Plovdiv

4400

Research Site, Nyíregyháza

4710

Research Site, Braga

5000

Research Site, Namur

5020

Research Site, Salzburg

6100

Research Site, Ankara

6807

Research Site, Feldkirch

7100

Research Site, Szekszárd

8008

Research Site, Zurich

8035

Research Site, Barcelona

8900

Research Site, Zalaegerszeg

9000

Research Site, Ghent

9024

Research Site, Győr

9100

Research Site, Sint-Niklaas

9700

Research Site, Shumen

10048

Research Site, Taipei

10408

Research Site, Goyang-si

10450

Research Site, George Town

11029

Research Site, New Delhi

13125

Research Site, Berlin

14076

Research Site, Caen

20089

Research Site, Rozzano

20141

Research Site, Milan

20904

Research Site, Silver Spring

21079

Research Site, Dijon

22031

Research Site, Fairfax

22190

Research Site, Plerin SUR MER

23007

Research Site, Jaén

23040

Research Site, La Paz

24127

Research Site, Bergamo

25030

Research Site, Besançon

25198

Research Site, Lleida

26505

Research Site, Morgantown

28040

Research Site, Madrid

28046

Research Site, Madrid

28100

Research Site, Novara

29010

Research Site, Málaga

29169

Research Site, West Columbia

29609

Research Site, Brest

31008

Research Site, Pamplona

32256

Research Site, Jacksonville

33030

Research Site, Bordeaux

33401

Research Site, West Palm Beach

34070

Research Site, Montpellier

35100

Research Site, Izmir

35128

Research Site, Padua

35620

Research Site, Izmir

36604

Research Site, Mobile

37203

Research Site, Nashville

37404

Research Site, Chattanooga

38039

Research Site, Kayseri

39008

Research Site, Santander

39401

Research Site, Hattiesburg

40443

Research Site, Taichung

41013

Research Site, Seville

41061

Research Site, Mönchengladbach

41124

Research Site, Modena

41404

Research Site, Daegu

42551

Research Site, Velbert

43100

Research Site, Parma

45136

Research Site, Essen

45219

Research Site, Cincinnati

45267

Research Site, Cincinnati

46015

Research Site, Valencia

46256

Research Site, Indianapolis

48145

Research Site, Münster

48202

Research Site, Detroit

49201

Research Site, Busan

50080

Research Site, Estado de México

50139

Research Site, Florence

50586

Research Site, Kuala Lumpur

54000

Research Site, Vandœuvre-lès-Nancy

57105

Research Site, Sioux Falls

59000

Research Site, Lille

59100

Research Site, Prato

Research Site, Kuala Lumpur

62250

Research Site, Kuala Selangor

64710

Research Site, Monterrey

68130

Research Site, Omaha

69495

Research Site, Pierre-Bénite

70403

Research Site, Tainan City

70809

Research Site, Baton Rouge

72000

Research Site, Le Mans

72424

Research Site, Puebla City

72762

Research Site, Springdale

75702

Research Site, Tyler

77030

Research Site, Houston

77090

Research Site, Houston

78731

Research Site, Austin

79110

Research Site, Freiburg im Breisgau

80124

Research Site, Lone Tree

80131

Research Site, Napoli

81100

Research Site, Johor Bahru

81250

Research Site, Bratislava

81675

Research Site, München

82445

Research Site, Kaohsiung City

90710

Research Site, Harbor City

91171

Research Site, Trenčín

92210

Research Site, Saint-Cloud

93053

Research Site, Regensburg

93463

Research Site, Solvang

93586

Research Site, Kuching

94805

Research Site, Villejuif

97239

Research Site, Portland

98055

Research Site, Renton

99336

Research Site, Kennewick

100039

Research Site, Beijing

100142

Research Site, Beijing

110001

Research Site, Shenyang

110085

Research Site, Delhi

111123

Research Site, Moscow

115478

Research Site, Moscow

116011

Research Site, Dalian

117997

Research Site, Moscow

121001

Research Site, Faridabad

121467

Research Site, Moscow

122001

Research Site, Gūrgaon

130000

Research Site, Changchun

130021

Research Site, Changchun

190103

Research Site, Saint Petersburg

195067

Research Site, Saint Petersburg

196603

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

200025

Research Site, Shanghai

200032

Research Site, Shanghai

210008

Research Site, Nanjing

230031

Research Site, Hefei

233060

Research Site, Bengbu

248007

Research Site, Kaluga

250117

Research Site, Jinan

276000

Research Site, Linyi

300060

Research Site, Tianjin

305524

Research Site, Kislino Village, Ryshkovsky Ru

310020

Research Site, Hangzhou

310022

Research Site, Hangzhou

330009

Research Site, Nanchang

380060

Research Site, Ahmedabad

388325

Research Site, Karamsad

400042

Research Site, Chongqing

410013

Research Site, Changsha

422009

Research Site, Nashik

422011

Research Site, Nashik

430000

Research Site, Wuhan

430022

Research Site, Wuhan

440001

Research Site, Nagpur

450008

Research Site, Zhengzhou

510060

Research Site, Guangzhou

510100

Research Site, Guangzhou

550004

Research Site, Guiyang

570311

Research Site, Haikou

610042

Research Site, Chengdu

625107

Research Site, Madurai

673601

Research Site, Calicut

700160

Research Site, Kolkata

710061

Research Site, Xi'an

730000

Research Site, Lanzhou

1720430

Research Site, La Serena

4070196

Research Site, Concepción

7630370

Research Site, Santiago

8241479

Research Site, Santiago

33901-8101

Research Site, Fort Myers

02114

Research Site, Boston

T6G 1Z2

Research Site, Edmonton

V5Z 1H7

Research Site, Vancouver

N2G 1G3

Research Site, Kitchener

N6A 5W9

Research Site, London

M5G 2M9

Research Site, Toronto

H3T 1E2

Research Site, Montreal

071000

Research Site, Baoding

Unknown

Research Site, Beijing

Research Site, Kaohsiung City

268 01

Research Site, Hořovice

500 05

Research Site, Hradec Králové

741 01

Research Site, Nový Jičín

100 34

Research Site, Prague

140 00

Research Site, Prague

150 06

Research Site, Prague

06847

Research Site, Dessau-RoBlau

00168

Research Site, Roma

260-8717

Research Site, Chiba

104-0045

Research Site, Chūōku

862-8655

Research Site, Chūōku

350-1298

Research Site, Hidaka-shi

573-1191

Research Site, Hirakata-shi

259-1193

Research Site, Isehara-shi

362-0806

Research Site, Kitaadachi-gun

135-8550

Research Site, Kōtoku

860-8556

Research Site, Kumamoto

701 0192

Research Site, Kurashiki Shi

830-0013

Research Site, Kurume-shi

606-8507

Research Site, Kyoto

464-8681

Research Site, Nagoya

467-8602

Research Site, Nagoya

663-8501

Research Site, Nishinomiya-shi

540-0006

Research Site, Osaka

541-8567

Research Site, Osaka

373-8550

Research Site, Ota-shi

003-0804

Research Site, Sapporo

980-8574

Research Site, Sendai

329-0498

Research Site, Shimotsuke-shi

142-8666

Research Site, Shinagawa-ku

162-8655

Research Site, Shinjuku-ku

565-0871

Research Site, Suita-shi

370-0829

Research Site, Takasaki-shi

514-8507

Research Site, Tsu

305-8576

Research Site, Tsukuba

241-8515

Research Site, Yokohama

06700

Research Site, Del. Cuauhtemoc

0 3100

Research Site, Mexico City

N-0379

Research Site, Oslo

81-519

Research Site, Gdynia

62-500

Research Site, Konin

75-581

Research Site, Koszalin

90-302

Research Site, Lodz

20-090

Research Site, Lublin

10-513

Research Site, Olsztyn

60-192

Research Site, Poznan

4835-044

Research Site, Guimarães

1400-038

Research Site, Lisbon

1500-650

Research Site, Lisbon

1998-018

Research Site, Lisbon

2674-514

Research Site, Loures

4099-001

Research Site, Porto

4200-319

Research Site, Porto

4434-502

Research Site, Vila Nova de Gaia

974 01

Research Site, Banská Bystrica

833 01

Research Site, Bratislava

081 81

Research Site, Prešov

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

08908

Research Site, Barcelona

CH- 4410

Research Site, Liestal

01120

Research Site, Adana

06010

Research Site, Ankara

06230

Research Site, Ankara

06340

Research Site, Ankara

CB2 2QQ

Research Site, Cambridge

CO4 5JL

Research Site, Colchester

LS9 7TF

Research Site, Leeds

NG5 1PB

Research Site, Nottingham

GU2 7XX

Research Site, Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY