Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

November 26, 2027

Conditions
ER-Positive HER2-Negative Breast Cancer
Interventions
DRUG

AZD9833

Dosage formulation: AZD9833 tablets will be administered orally

DRUG

AZD9833 Placebo

Dosage formulation: AZD9833 placebo tablets will be administrated orally.

DRUG

Anastrozole

Dosage formulation: anastrozole tablets will be administered orally.

DRUG

Anastrozole placebo

Dosage formulation: anastrozole placebo tablets will be administrated orally.

DRUG

Letrozole

Dosage formulation: letrozole tablets will be administered orally.

DRUG

Letrozole placebo

Dosage formulation: letrozole placebo tablets will be administered orally.

DRUG

Palbociclib

Dosage formulation: palbociclib tablets/capsules will be administered orally

DRUG

Abemaciclib

Dosage formulation: abemaciclib tablets 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.

DRUG

Ribociclib

Dosage formulation: ribociclib tablets will be administered orally

Trial Locations (265)

100

Research Site, Taipei

110

Research Site, Taipei

333

Research Site, Taoyuan District

710

Research Site, Tainan City

833

Research Site, Kaohsiung City

1062

Research Site, Budapest

1122

Research Site, Budapest

1130

Research Site, Vienna

1303

Research Site, Sofia

1330

Research Site, Sofia

1407

Research Site, Sofia

1431

Research Site, Sofia

1527

Research Site, Sofia

2010

Research Site, Darlinghurst

3000

Research Site, Leuven

3004

Research Site, Drammen

3526

Research Site, Miskolc

4000

Research Site, Liège

4004

Research Site, Plovdiv

4103

Research Site, Leipzig

4500

Research Site, Panagyurishte

4575

Research Site, Birtinya

5000

Research Site, Namur

Research Site, Szolnok

5020

Research Site, Salzburg

5804

Research Site, Pleven

6020

Research Site, Innsbruck

6300

Research Site, Haskovo

7100

Research Site, Szekszárd

8035

Research Site, Barcelona

8036

Research Site, Graz

8401

Research Site, Winterthur

8900

Research Site, Zalaegerszeg

10065

Research Site, New York

10408

Research Site, Goyang-si

11042

Research Site, New Hyde Park

11215

Research Site, Brooklyn

11259

Research Site, Taipei

11355

Research Site, New York

11490

Research Site, Taipei

11967

Research Site, Shirley

13057

Research Site, East Syracuse

13273

Research Site, Marseille

13620

Research Site, Seongnam-si

15009

Research Site, A Coruña

15213

Research Site, Pittsburgh

17403

Research Site, York

19104

Research Site, Philadelphia

20089

Research Site, Rozzano

20132

Research Site, Milan

20141

Research Site, Milan

21079

Research Site, Dijon

21202

Research Site, Baltimore

21680

Research Site, Stade

23114

Research Site, Midlothian

23502

Research Site, Norfolk

23561

Research Site, Taipei

24127

Research Site, Bergamo

27534

Research Site, Goldsboro

28040

Research Site, Madrid

28041

Research Site, Madrid

29010

Research Site, Málaga

29169

Research Site, West Columbia

29200

Research Site, Brest

29607

Research Site, Greenville

30008

Research Site, Murcia

30029

Research Site, Nîmes

30318

Research Site, Atlanta

30322

Research Site, Atlanta

30342

Research Site, Atlanta

31100

Research Site, Toulouse

31151

Research Site, Cheonan-si

32224

Research Site, Jacksonville

32256

Research Site, Jacksonville

33098

Research Site, Paderborn

33705

Research Site, St. Petersburg

33901

Research Site, Fort Myers

34722

Research Site, Kadıkoy/Istanbul

35100

Research Site, Izmir

35128

Research Site, Padua

35360

Research Site, Izmir

35575

Research Site, Karşıyaka

37000

Research Site, Tours

37203

Research Site, Nashville

37916

Research Site, Knoxville

38039

Research Site, Kayseri

38120

Research Site, Memphis

38655

Research Site, Oxford

40138

Research Site, Bologna

40705

Research Site, Taichung

40878

Research Site, Ratingen

41013

Research Site, Seville

42415

Research Site, Daegu

43219

Research Site, Columbus

44710

Research Site, Canton

44805

Research Site, Saint-Herblain

45130

Research Site, Essen

45220

Research Site, Cincinnati

46010

Research Site, Valencia

46250

Research Site, Indianapolis

46804

Research Site, Fort Wayne

47014

Research Site, Meldola

48202

Research Site, Detroit

49503

Research Site, Grand Rapids

50134

Research Site, Florence

53111

Research Site, Bonn

53226

Research Site, Waukesha

54519

Research Site, Vandœuvre-lès-Nancy

55905

Research Site, Rochester

56068

Research Site, Koblenz

56322

Research Site, Lorient

57070

Research Site, Vantoux

59101

Research Site, Billings

60068

Research Site, Park Ridge

63050

Research Site, Clermont-Ferrand

63110

Research Site, St Louis

63739

Research Site, Aschaffenburg

64111

Research Site, Kansas City

68130

Research Site, Omaha

68167

Research Site, Mannheim

69373

Research Site, Lyon

70403

Research Site, Tainan City

71913

Research Site, Hot Springs

72076

Research Site, Tübingen

72205

Research Site, Little Rock

74370

Research Site, Metz-Tessy

75063

Research Site, Irving

75246

Research Site, Dallas

75248

Research Site, Paris

75601

Research Site, Longview

76021

Research Site, Rouen

76022

Research Site, Bedford

77024

Research Site, Houston

77030

Research Site, Houston

78240

Research Site, San Antonio

79110

Research Site, Freiburg im Breisgau

80124

Research Site, Lone Tree

80131

Research Site, Napoli

80634

Research Site, München

81501

Research Site, Grand Junction

83000

Research Site, Limoges

84106

Research Site, Salt Lake City

84918

Research Site, Avignon

85054

Research Site, Phoenix

86156

Research Site, Augsburg

87509

Research Site, Immenstadt im Allgäu

88212

Research Site, Ravensburg

89075

Research Site, Ulm

90806

Research Site, Long Beach

91054

Research Site, Erlangen

91120

Research Site, Jerusalem

91522

Research Site, Ansbach

92123

Research Site, San Diego

92210

Research Site, Saint-Cloud

92805

Research Site, Santa Rosa

93053

Research Site, Regensburg

94805

Research Site, Villejuif

95045

Research Site, Misterbianco

97213

Research Site, Portland

98405

Research Site, Tacoma

111123

Research Site, Moscow

129090

Research Site, Moscow

142100

Research Site, Podolsk

143423

Research Site, Moscow

194017

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

494142

Research Site, Petah Tikva

603126

Research Site, Nizhny Novgorod

3109601

Research Site, Haifa

5262000

Research Site, Ramat Gan

8410101

Research Site, Beersheba

02215

Research Site, Boston

02719

Research Site, Fairhaven

02035

Research Site, Foxborough

01757

Research Site, Milford

02190

Research Site, South Weymouth

08103

Research Site, Camden

07450

Research Site, Ridgewood

T2N 5G2

Research Site, Calgary

V5Z 4E6

Research Site, Vancouver

K1H 8L6

Research Site, Ottawa

G6V 3Z1

Research Site, Lévis

H1T 2M4

Research Site, Montreal

H2X 0C1

Research Site, Montreal

H3T 1E2

Research Site, Montreal

G1S 4L8

Research Site, Québec

09116

Research Site, Chemnitz

01307

Research Site, Dresden

00168

Research Site, Roma

260-8717

Research Site, Chiba

104-0045

Research Site, Chūōku

350-1298

Research Site, Hidaka-shi

573-1191

Research Site, Hirakata-shi

362-0806

Research Site, Kitaadachi-gun

135-8550

Research Site, Kōtoku

860-8556

Research Site, Kumamoto

791-0280

Research Site, Matsuyama

464-8681

Research Site, Nagoya

467-8602

Research Site, Nagoya

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

162-8655

Research Site, Shinjuku-ku

370-0829

Research Site, Takasaki-shi

569-8686

Research Site, Takatsuki-shi

305-8577

Research Site, Tsukuba

241-8515

Research Site, Yokohama

0450

Research Site, Oslo

85-796

Research Site, Bydgoszcz

81-519

Research Site, Gdynia

75-581

Research Site, Koszalin

90-302

Research Site, Lodz

60-693

Research Site, Poznan

35-001

Research Site, Rzeszów

97-200

Research Site, Tomaszów Mazowiecki

02-781

Research Site, Warsaw

4835-044

Research Site, Guimarães

1400-038

Research Site, Lisbon

1449-005

Research Site, Lisbon

1500-650

Research Site, Lisbon

1649-035

Research Site, Lisbon

2674-514

Research Site, Loures

4099-001

Research Site, Porto

4200-072

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

041 91

Research Site, Košice

07101

Research Site, Michalovce

958 01

Research Site, Partizánske

463-712

Research Site, Seongnam-si

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

06591

Research Site, Seoul

08003

Research Site, Badalona

08908

Research Site, L'Hospitalet de Llobregat

08970

Research Site, Sant Joan Despí

CH-3010

Research Site, Bern

CH-7000

Research Site, Chur

Unknown

Research Site, Taipei

01120

Research Site, Adana

06010

Research Site, Ankara

06100

Research Site, Ankara

06340

Research Site, Ankara

06520

Research Site, Ankara

FY3 8NR

Research Site, Blackpool

CB2 0QQ

Research Site, Cambridge

SW3 6JJ

Research Site, London

WC1N 3BG

Research Site, London

M20 4BX

Research Site, Manchester

NP10 8FZ

Research Site, Newport

NG5 1PB

Research Site, Nottingham

PO6 3LY

Research Site, Portsmouth

RG2 9LH

Research Site, Reading

S10 2SJ

Research Site, Sheffield

SM2 5PT

Research Site, Sutton

TA1 5DA

Research Site, Taunton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY