Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

PHASE3RecruitingINTERVENTIONAL
Enrollment

895

Participants

Timeline

Start Date

May 10, 2021

Primary Completion Date

November 1, 2027

Study Completion Date

August 14, 2029

Conditions
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Interventions
DRUG

Capivasertib

Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion

DRUG

Fulvestrant

Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter

DRUG

Palbociclib

Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.

DRUG

Ribociclib

Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.

DRUG

Abemaciclib

Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle

Trial Locations (282)

333

RECRUITING

Research Site, Taoyuan District

704

RECRUITING

Research Site, Tainan City

1200

RECRUITING

Research Site, Brussels

1414

ACTIVE_NOT_RECRUITING

Research Site, CABA

1425

ACTIVE_NOT_RECRUITING

Research Site, CABA

1439

ACTIVE_NOT_RECRUITING

Research Site, Buenos Aires

2000

ACTIVE_NOT_RECRUITING

Research Site, Rosario

2010

RECRUITING

Research Site, Darlinghurst

2076

WITHDRAWN

Research Site, Wahroonga

2228

WITHDRAWN

Research Site, Miranda

2298

RECRUITING

Research Site, Waratah

2650

RECRUITING

Research Site, Edegem

2930

RECRUITING

Research Site, Brasschaat

3000

RECRUITING

Research Site, Leuven

3400

RECRUITING

Research Site, Hillerød

5000

RECRUITING

Research Site, Odense

5505

ACTIVE_NOT_RECRUITING

Research Site, Seoul

6009

ACTIVE_NOT_RECRUITING

Research Site, Nedlands

RECRUITING

Research Site, Nedlands

6100

ACTIVE_NOT_RECRUITING

Research Site, Ankara

7100

RECRUITING

Research Site, Haine-Saint-Paul

8035

RECRUITING

Research Site, Barcelona

8200

RECRUITING

Research Site, Aarhus N

9000

RECRUITING

Research Site, Aalborg

10002

RECRUITING

Research Site, Taipei

10016

RECRUITING

Research Site, New York

10065

RECRUITING

Research Site, New York

10210

ACTIVE_NOT_RECRUITING

Research Site, Bangkok

10300

ACTIVE_NOT_RECRUITING

Research Site, Dusit

10330

ACTIVE_NOT_RECRUITING

Research Site, Bangkok

10350

RECRUITING

Research Site, George Town

10400

WITHDRAWN

Research Site, Bangkok

ACTIVE_NOT_RECRUITING

Research Site, Bangkok

ACTIVE_NOT_RECRUITING

Research Site, Ratchathewi

10408

ACTIVE_NOT_RECRUITING

Research Site, Goyang-si

10449

RECRUITING

Research Site, Taipei

10450

RECRUITING

Research Site, Pulau Pinang

10700

ACTIVE_NOT_RECRUITING

Research Site, Bangkok

10967

RECRUITING

Research Site, Berlin

11220

WITHDRAWN

Research Site, Brooklyn

11501

RECRUITING

Research Site, Mineola

13125

RECRUITING

Research Site, Berlin

15213

RECRUITING

Research Site, Pittsburgh

15706

RECRUITING

Research Site, Santiago de Compostela

17176

RECRUITING

Research Site, Solna

17403

TERMINATED

Research Site, York

18014

RECRUITING

Research Site, Granada

19104

RECRUITING

Research Site, Philadelphia

19713

RECRUITING

Research Site, Newark

20089

WITHDRAWN

Research Site, Rozzano

20132

WITHDRAWN

Research Site, Milan

20141

WITHDRAWN

Research Site, Milan

20176

RECRUITING

Research Site, Leesburg

20357

RECRUITING

Research Site, Hamburg

21202

WITHDRAWN

Research Site, Baltimore

21229

WITHDRAWN

Research Site, Baltimore

21401

RECRUITING

Research Site, Annapolis

21680

WITHDRAWN

Research Site, Stade

22042

RECRUITING

Research Site, Falls Church

22190

RECRUITING

Research Site, Plérin

23114

RECRUITING

Research Site, Midlothian

23502

RECRUITING

Research Site, Norfolk

24105

RECRUITING

Research Site, Kiel

25198

RECRUITING

Research Site, Lleida

27710

WITHDRAWN

Research Site, Durham

28034

RECRUITING

Research Site, Madrid

28040

RECRUITING

Research Site, Madrid

28046

WITHDRAWN

Research Site, Madrid

29010

RECRUITING

Research Site, Málaga

29607

TERMINATED

Research Site, Greenville

30625

RECRUITING

Research Site, Hanover

31000

RECRUITING

Research Site, Hangzhou

31008

RECRUITING

Research Site, Pamplona

33081

WITHDRAWN

Research Site, Aviano

35128

RECRUITING

Research Site, Padua

35185

RECRUITING

Research Site, Vaxjo

35575

ACTIVE_NOT_RECRUITING

Research Site, Karşıyaka

37203

RECRUITING

Research Site, Nashville

37404

RECRUITING

Research Site, Chattanooga

38039

WITHDRAWN

Research Site, Kayseri

40002

ACTIVE_NOT_RECRUITING

Research Site, Khon Kaen

40138

RECRUITING

Research Site, Bologna

40202

WITHDRAWN

Research Site, Louisville

RECRUITING

Research Site, Louisville

41061

RECRUITING

Research Site, Mönchengladbach

44280

ACTIVE_NOT_RECRUITING

Research Site, Malatya

44805

RECRUITING

Research Site, Saint-Herblain

45136

NOT_YET_RECRUITING

Research Site, Essen

46050

RECRUITING

Research Site, Kuala Selangor

46236

RECRUITING

Research Site, Bottrop

46804

WITHDRAWN

Research Site, Fort Wayne

48149

WITHDRAWN

Research Site, Münster

48236

RECRUITING

Research Site, Detroit

49124

RECRUITING

Research Site, Georgsmarienhütte

49503

RECRUITING

Research Site, Grand Rapids

50141

RECRUITING

Research Site, Florence

50200

ACTIVE_NOT_RECRUITING

Research Site, Chiang Mai

50586

RECRUITING

Research Site, Kuala Lumpur

52000

ACTIVE_NOT_RECRUITING

Research Site, Lampang

54290

RECRUITING

Research Site, Trier

55200

ACTIVE_NOT_RECRUITING

Research Site, Samsun

59100

RECRUITING

Research Site, Prato

RECRUITING

Research Site, Kuala Lumpur

62250

RECRUITING

Research Site, Kuala Selangor

62305

RECRUITING

Research Site, Quincy

63011

RECRUITING

Research Site, Clermont-Ferrand

63110

RECRUITING

Research Site, St Louis

63401

RECRUITING

Research Site, Hannibal

65929

RECRUITING

Research Site, Frankfurt am Main

68130

RECRUITING

Research Site, Omaha

68167

RECRUITING

Research Site, Mannheim

69008

RECRUITING

Research Site, Lyon

70000

RECRUITING

Research Site, Ho Chi Minh City

70433

WITHDRAWN

Research Site, Covington

70809

WITHDRAWN

Research Site, Baton Rouge

74078

RECRUITING

Research Site, Heilbronn

75246

RECRUITING

Research Site, Dallas

76021

RECRUITING

Research Site, Rouen

76104

WITHDRAWN

Research Site, Fort Worth

77030

SUSPENDED

Research Site, Houston

78229

RECRUITING

Research Site, San Antonio

78240

RECRUITING

Research Site, San Antonio

79106

RECRUITING

Research Site, Freiburg im Breisgau

80045

RECRUITING

Research Site, Aurora

80131

RECRUITING

Research Site, Napoli

80756

RECRUITING

Research Site, Kaohsiung City

83301

RECRUITING

Research Site, Kaohsiung City

84106

NOT_YET_RECRUITING

Research Site, Salt Lake City

85719

RECRUITING

Research Site, Tucson

86150

RECRUITING

Research Site, Augsburg

87042

RECRUITING

Research Site, Limoges

88100

WITHDRAWN

Research Site, Catanzaro

89075

RECRUITING

Research Site, Ulm

90033

SUSPENDED

Research Site, Los Angeles

90048

WITHDRAWN

Research Site, Los Angeles

90110

ACTIVE_NOT_RECRUITING

Research Site, Hat Yai

91054

RECRUITING

Research Site, Erlangen

91204

RECRUITING

Research Site, Glendale

92663

SUSPENDED

Research Site, Newport Beach

92708

RECRUITING

Research Site, Fountain Valley

92805

RECRUITING

Research Site, Santa Rosa

93000

RECRUITING

Research Site, Bobigny

93053

RECRUITING

Research Site, Regensburg

93105

WITHDRAWN

Research Site, Santa Barbara

93586

RECRUITING

Research Site, Kuching

94158

RECRUITING

Research Site, San Francisco

94558

RECRUITING

Research Site, Napa

94805

RECRUITING

Research Site, Villejuif

95045

RECRUITING

Research Site, Misterbianco

97030

RECRUITING

Research Site, Gresham

98405

RECRUITING

Research Site, Tacoma

100000

RECRUITING

Research Site, Hanoi

100039

ACTIVE_NOT_RECRUITING

Research Site, Beijing

100044

ACTIVE_NOT_RECRUITING

Research Site, Beijing

100191

RECRUITING

Research Site, Beijing

100210

RECRUITING

Research Site, Beijing

110001

RECRUITING

Research Site, Shenyang

110016

RECRUITING

Research Site, Shenyang

110075

RECRUITING

Research Site, New Delhi

110076

RECRUITING

Research Site, New Delhi

130000

RECRUITING

Research Site, Changchun

160055

RECRUITING

Research Site, Mohali

200032

RECRUITING

Research Site, Shanghai

210029

RECRUITING

Research Site, Nanjing

221005

RECRUITING

Research Site, Varanasi

221009

RECRUITING

Research Site, Xuzhou

230031

RECRUITING

Research Site, Hefei

233004

RECRUITING

Research Site, Bengbu

250001

RECRUITING

Research Site, Jinan

302017

WITHDRAWN

Research Site, Jaipur

302022

WITHDRAWN

Research Site, Jaipur

310016

RECRUITING

Research Site, Hangzhou

310022

RECRUITING

Research Site, Hangzhou

330006

ACTIVE_NOT_RECRUITING

Research Site, Nanchang

330009

RECRUITING

Research Site, Nanchang

391760

RECRUITING

Research Site, Vadodara

400042

RECRUITING

Research Site, Chongqing

410013

ACTIVE_NOT_RECRUITING

Research Site, Changsha

422122

WITHDRAWN

Research Site, Reggio Emilia

430060

ACTIVE_NOT_RECRUITING

Research Site, Wuhan

440001

RECRUITING

Research Site, Nagpur

441000

WITHDRAWN

Research Site, Xiangyang

450008

RECRUITING

Research Site, Zhengzhou

460000

RECRUITING

Research Site, Vinh

510060

RECRUITING

Research Site, Guangzhou

510062

ACTIVE_NOT_RECRUITING

Research Site, Guangzhou

510080

WITHDRAWN

Research Site, Guangzhou

530021

ACTIVE_NOT_RECRUITING

Research Site, Nanning

560004

RECRUITING

Research Site, Bangalore

570017

RECRUITING

Research Site, Mysuru

605006

WITHDRAWN

Research Site, Puducherry

610041

RECRUITING

Research Site, Chengdu

700000

RECRUITING

Research Site, Ho Chi Minh City

RECRUITING

Research Site, Hồ Chí Minh

710061

ACTIVE_NOT_RECRUITING

Research Site, Xi'an

710100

WITHDRAWN

Research Site, Xi'an

830000

WITHDRAWN

Research Site, Ürümqi

ACTIVE_NOT_RECRUITING

Research Site, Ürümqi

900000

RECRUITING

Research Site, Can Tho

06510

RECRUITING

Research Site, New Haven

02215

RECRUITING

Research Site, Boston

08103

RECRUITING

Research Site, Camden

02903

WITHDRAWN

Research Site, Providence

C1125ABD

ACTIVE_NOT_RECRUITING

Research Site, Buenos Aires

C1425

SUSPENDED

Research Site, CABA

B6620LUD

ACTIVE_NOT_RECRUITING

Research Site, Chivilcoy

S2002RE

WITHDRAWN

Research Site, Santa Fe

37130-000

ACTIVE_NOT_RECRUITING

Research Site, Alfenas

89010-340

ACTIVE_NOT_RECRUITING

Research Site, Blumenau

59075-740

ACTIVE_NOT_RECRUITING

Research Site, Natal

90035-903

ACTIVE_NOT_RECRUITING

Research Site, Porto Alegre

76834-899

ACTIVE_NOT_RECRUITING

Research Site, Porto Velho

04014-002

ACTIVE_NOT_RECRUITING

Research Site, São Paulo

12030-200

ACTIVE_NOT_RECRUITING

Research Site, Taubaté

64049-200

ACTIVE_NOT_RECRUITING

Research Site, Teresina

29043-260

ACTIVE_NOT_RECRUITING

Research Site, Vitória

V2S0C2

RECRUITING

Research Site, Abbotsford

V1Y 5L3

RECRUITING

Research Site, Kelowna

R3E 0V9

WITHDRAWN

Research Site, Winnipeg

E1C 6Z8

WITHDRAWN

Research Site, Moncton

B3H 1V7

RECRUITING

Research Site, Halifax

L6R 3J7

RECRUITING

Research Site, Brampton

K1H 8L6

RECRUITING

Research Site, Ottawa

P6A 2C4

WITHDRAWN

Research Site, Sault Ste. Marie

M5B 1W8

RECRUITING

Research Site, Toronto

J1H 5N4

RECRUITING

Research Site, Sherbrooke

G7H 5H6

RECRUITING

Research Site, Chicoutimi

H3T 1E2

RECRUITING

Research Site, Montreal

Unknown

RECRUITING

Research Site, Shandong

RECRUITING

Research Site, Taichung

ACTIVE_NOT_RECRUITING

Research Site, Goztepe Istanbul

01307

RECRUITING

Research Site, Dresden

04103

RECRUITING

Research Site, Leipzig

00168

RECRUITING

Research Site, Roma

260-8717

ACTIVE_NOT_RECRUITING

Research Site, Chiba

104-0045

ACTIVE_NOT_RECRUITING

Research Site, Chūōku

104-8560

ACTIVE_NOT_RECRUITING

Research Site, Chūōku

350-1298

ACTIVE_NOT_RECRUITING

Research Site, Hidaka-shi

573-1191

RECRUITING

Research Site, Hirakata-shi

730-8518

ACTIVE_NOT_RECRUITING

Research Site, Hiroshima

259-1193

ACTIVE_NOT_RECRUITING

Research Site, Isehara-shi

892-0833

ACTIVE_NOT_RECRUITING

Research Site, Kagoshima

135-8550

ACTIVE_NOT_RECRUITING

Research Site, Kōtoku

606-8507

ACTIVE_NOT_RECRUITING

Research Site, Kyoto

791-0280

ACTIVE_NOT_RECRUITING

Research Site, Matsuyama

464-8681

NOT_YET_RECRUITING

Research Site, Nagoya

901-0154

ACTIVE_NOT_RECRUITING

Research Site, Naha

700-8558

RECRUITING

Research Site, Okayama

541-8567

ACTIVE_NOT_RECRUITING

Research Site, Osaka

373-8550

ACTIVE_NOT_RECRUITING

Research Site, Ota-shi

060-8638

ACTIVE_NOT_RECRUITING

Research Site, Sapporo

980-8574

ACTIVE_NOT_RECRUITING

Research Site, Sendai

329-0498

ACTIVE_NOT_RECRUITING

Research Site, Shimotsuke-shi

142-8666

ACTIVE_NOT_RECRUITING

Research Site, Shinagawa-ku

162-8655

ACTIVE_NOT_RECRUITING

Research Site, Shinjuku-ku

565-0871

ACTIVE_NOT_RECRUITING

Research Site, Suita-shi

370-0829

ACTIVE_NOT_RECRUITING

Research Site, Takasaki-shi

514-8507

ACTIVE_NOT_RECRUITING

Research Site, Tsu

241-8515

ACTIVE_NOT_RECRUITING

Research Site, Yokohama

15-027

WITHDRAWN

Research Site, Bialystok

85-796

ACTIVE_NOT_RECRUITING

Research Site, Bydgoszcz

80-952

RECRUITING

Research Site, Gdansk

75-581

WITHDRAWN

Research Site, Koszalin

31-501

ACTIVE_NOT_RECRUITING

Research Site, Krakow

90-302

NOT_YET_RECRUITING

Research Site, Lodz

91-211

NOT_YET_RECRUITING

Research Site, Lodz

20-090

WITHDRAWN

Research Site, Lublin

35-326

WITHDRAWN

Research Site, Rzeszów

02-781

COMPLETED

Research Site, Warsaw

NOT_YET_RECRUITING

Research Site, Warsaw

02841

ACTIVE_NOT_RECRUITING

Research Site, Seoul

03080

ACTIVE_NOT_RECRUITING

Research Site, Seoul

03722

ACTIVE_NOT_RECRUITING

Research Site, Seoul

06273

ACTIVE_NOT_RECRUITING

Research Site, Seoul

06351

ACTIVE_NOT_RECRUITING

Research Site, Seoul

221 85

RECRUITING

Research Site, Lund

07070

ACTIVE_NOT_RECRUITING

Research Site, Antalya

CU2 7XX

RECRUITING

Research Site, Guildford

SE1 9RT

RECRUITING

Research Site, London

BT47 6SB

RECRUITING

Research Site, Londonderry

TA1 5DA

RECRUITING

Research Site, Taunton

YO21 8HE

RECRUITING

Research Site, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT04862663 - Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) | Biotech Hunter | Biotech Hunter