Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

923

Participants

Timeline

Start Date

June 25, 2019

Primary Completion Date

March 16, 2026

Study Completion Date

March 16, 2026

Conditions
Triple Negative Breast Neoplasms
Interventions
DRUG

Capivasertib

400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.

DRUG

Paclitaxel

80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.

DRUG

Placebo

Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle

Trial Locations (260)

104

Research Site, Taipei

114

Research Site, Taipei

235

Research Site, Taipei

300

Research Site, Hsinchu

710

Research Site, Tainan City

1000

Research Site, Manila

1062

Research Site, Budapest

1097

Research Site, Budapest

1106

Research Site, Budapest

1112

Research Site, Quezon City

1414

Research Site, CABA

1426

Research Site, Ciudad Autonomade Buenos Aires

1500

Research Site, San Juan City

1740

Research Site, Las Piñas

1900

Research Site, La Plata

2000

Research Site, Rosario

2193

Research Site, Johannesburg

2196

Research Site, Johannesburg

2600

Research Site, Baguio City

4400

Research Site, Nyíregyháza

4500

Research Site, Legaspi

5000

Research Site, Iloilo City

6000

Research Site, Cebu City

6100

Research Site, Bacolod

6189

Research Site, Nice

7100

Research Site, Szekszárd

7600

Research Site, Mar del Plata

8000

Research Site, Davao City

8035

Research Site, Barcelona

9000

Research Site, Cagayan de Oro

9024

Research Site, Győr

10210

Research Site, Bangkok

10330

Research Site, Bangkok

10400

Research Site, Bangkok

10408

Research Site, Goyang-si

10700

Research Site, Bangkok

10960

Research Site, Nyack

11029

Research Site, New Delhi

11217

Research Site, Taipei

11426

Research Site, Riyadh

11525

Research Site, Riyadh

11528

Research Site, Athens

12311

Research Site, Riyadh

12462

Research Site, Athens

12713

Research Site, Riyadh

13009

Research Site, Marseille

13620

Research Site, Seongnam-si

15033

Research Site, Lima

15213

Research Site, Pittsburgh

17109

Research Site, Harrisburg

19104

Research Site, Philadelphia

20230

Research Site, Aguascalientes

20910

Research Site, Silver Spring

21565

Research Site, Incheon

22031

Research Site, Fairfax

22384

Research Site, Jeddah

23001

Research Site, Montería

23007

Research Site, Jaén

24246

Research Site, Mecca

28046

Research Site, Madrid

28644

Research Site, Cheongju-si

29010

Research Site, Málaga

29038

Research Site, Tuxtla Gutiérrez

29090

Research Site, Tuxtla Gutiérrez

29609

Research Site, Brest

31151

Research Site, Cheonan-si

31444

Research Site, Dammam

33070

Research Site, Mersin

33136

Research Site, Miami

33612

Research Site, Tampa

33705

Research Site, St. Petersburg

33901

Research Site, Fort Myers

34070

Research Site, Montpellier

35100

Research Site, Izmir

37203

Research Site, Nashville

41009

Research Site, Seville

41404

Research Site, Daegu

43210

Research Site, Columbus

44280

Research Site, Malatya

44680

Research Site, Guadalajara

44805

Research Site, Saint-Herblain

45220

Research Site, Cincinnati

46026

Research Site, Valencia

48202

Research Site, Detroit

50009

Research Site, Zaragoza

50080

Research Site, Estado de México

50200

Research Site, Mueang

50586

Research Site, Kuala Lumpur

54645

Research Site, Thessaloniki

59100

Research Site, Kuala Lumpur

60637

Research Site, Chicago

62250

Research Site, Kuala Selangor

64710

Research Site, Monterrey

66205

Research Site, Westwood

69008

Research Site, Lyon

71110

Research Site, Heraklion

73657

Research Site, Tainan City

75020

Research Site, Paris

76104

Research Site, Fort Worth

77090

Research Site, Houston

77900

Research Site, Olomouc

78229

Research Site, San Antonio

78758

Research Site, Austin

82445

Research Site, Kaohsiung City

83301

Research Site, Kaohsiung City

90110

Research Site, Hat Yai

90602

Research Site, Whittier

90603

Research Site, Whittier

93586

Research Site, Kuching

94805

Research Site, Villejuif

97002

Research Site, Hualien City

100000

Research Site, Hanoi

100021

Research Site, Beijing

110001

Research Site, Shenyang

110042

Research Site, Shenyang

110085

Research Site, New Delhi

115478

Research Site, Moscow

117997

Research Site, Moscow

121205

Research Site, Moscow

121467

Research Site, Moscow

122001

Research Site, Gūrgaon

130021

Research Site, Changchun

150054

Research Site, Yaroslavl

150081

Research Site, Harbin

163045

Research Site, Arkhangelsk

190103

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

200001

Research Site, Valledupar

200032

Research Site, Shanghai

210029

Research Site, Nanjing

230001

Research Site, Hefei

250117

Research Site, Jinan

276000

Research Site, Linyi

310003

Research Site, Hangzhou

310009

Research Site, Hangzhou

310022

Research Site, Hangzhou

325000

Research Site, Wenzhou

330009

Research Site, Nanchang

400012

Research Site, Mumbai

400138

Research Site, Volgograd

410013

Research Site, Changsha

410078

Research Site, Changsha

422002

Research Site, Nashik

430030

Research Site, Wuhan

440001

Research Site, Nagpur

440012

Research Site, Nagpur

450000

Research Site, Zhengzhou

473009

Research Site, Nanyang

510060

Research Site, Guangzhou

528000

Research Site, Foshan

550004

Research Site, Guiyang

560052

Research Site, Bangalore

560064

Research Site, Bangalore

570017

Research Site, Mysuru

570311

Research Site, Haikou

610000

Research Site, Chengdu

610072

Research Site, Chengdu

681004

Research Site, Floridablanca

700000

Research Site, Ho Chi Minh City

700054

Research Site, Kolkata

700160

Research Site, Kolkata

710061

Research Site, Xi'an

730006

Research Site, Ibagué

830000

Research Site, Ürümqi

5001000

Research Site, Medellín

C1125ABD

Research Site, Buenos Aires

C1012AAR

Research Site, CABA

C1019ABS

Research Site, CABA

C1426ANZ

Research Site, CABA

14784-400

Research Site, Barretos

88034-000

Research Site, Florianópolis

74605-070

Research Site, Goiânia

86015-520

Research Site, Londrina

59075-740

Research Site, Natal

90110-270

Research Site, Porto Alegre

90619-900

Research Site, Porto Alegre

20560-120

Research Site, Rio de Janeiro

15090-000

Research Site, São José do Rio Preto

01246-000

Research Site, São Paulo

01317-000

Research Site, São Paulo

04014-002

Research Site, São Paulo

V8R 6V5

Research Site, Victoria

N2G 1G3

Research Site, Kitchener

M2K 1E1

Research Site, North York

M5G 1X5

Research Site, Toronto

Unknown

Research Site, Beijing

Research Site, Wuhan

Research Site, Iloilo City

Research Site, Istanbul

Research Site, Ho Chi Minh City

500 05

Research Site, Hradec Králové

100 34

Research Site, Prague

128 08

Research Site, Prague

115 22

Research Site, Athens

113-8431

Research Site, Bunkyō City

811-1395

Research Site, Fukuoka

350-1298

Research Site, Hidaka-shi

730-8518

Research Site, Hiroshima

892-0833

Research Site, Kagoshima

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

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

980-8574

Research Site, Sendai

142-8666

Research Site, Shinagawa-ku

162-8655

Research Site, Shinjuku-ku

411-8777

Research Site, Sunto-gun

370-0829

Research Site, Takasaki-shi

514-8507

Research Site, Tsu

305-8576

Research Site, Tsukuba

241-8515

Research Site, Yokohama

06725

Research Site, México

AREQUIPA01

Research Site, Arequipa

CALLAO 02

Research Site, Callao

0051

Research Site, Lima

L27

Research Site, Lima

LIMA 34

Research Site, Lima

85-796

Research Site, Bydgoszcz

62-500

Research Site, Konin

61-866

Research Site, Poznan

47-400

Research Site, Racibórz

26-600

Research Site, Radom

97-200

Research Site, Tomaszów Mazowiecki

01-748

Research Site, Warsaw

53-413

Research Site, Wroclaw

1099-023

Research Site, Lisbon

1400-038

Research Site, Lisbon

1649-035

Research Site, Lisbon

4099-001

Research Site, Porto

833 01

Research Site, Bratislava

0002

Research Site, Pretoria

0084

Research Site, Pretoria

602-739

Research Site, Busan

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

08916

Research Site, Badalona

08025

Research Site, Barcelona

08907

Research Site, Hospitalet deLlobregat

413 45

Research Site, Gothenburg

221 85

Research Site, Lund

118 83

Research Site, Stockholm

06100

Research Site, Ankara

06520

Research Site, Ankara

EH4 2XU

Research Site, Edinburgh

E1 1BB

Research Site, London

NW3 2QG

Research Site, London

SE1 9RT

Research Site, London

S10 2SJ

Research Site, Sheffield

GU2 7XX

Research Site, Surrey

YO31 8HE

Research Site, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY