A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

November 25, 2019

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
Triple-Negative Breast Cancer
Interventions
DRUG

Atezolizumab

Atezolizumab was administered as per the dosage regimen mentioned in arm descriptions.

DRUG

Ipatasertib

Ipatasertib was administered as per the dosage regimen mentioned in arm descriptions.

DRUG

Paclitaxel

Paclitaxel was administered as per the dosage regimen mentioned in arm descriptions.

DRUG

Placebo for Atezolizumab

Placebo was administered as per the dosage regimen mentioned in arm descriptions.

DRUG

Placebo for Ipatasertib

Placebo was administered as per the dosage regimen mentioned in arm descriptions.

Trial Locations (182)

1

Hospital Arzobispo Loayza, Lima

41

Oncosalud Sac; Oncología, Lima

100

National Taiwan Uni Hospital; General Surgery, Taipei

333

Chang Gung Memorial Hosipital at Linkou, Taoyuan

404

China Medical University Hospital; Surgery, Taichung

1023

Auckland City Hospital, Cancer and Blood Research, Auckland

1090

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I, Vienna

1330

MHAT Nadezhda, Sofia

2013

Wits Clinical Research, Johannesberg

2065

Royal North Shore Hospital; Department of Medical Oncology, St Leonards

2109

Macquarie University Hospital, Macquarie Park

2298

Calvary Mater Newcastle; Medical Oncology, Waratah

2444

Mid North Coast Cancer Institute, Port Macquarie

2730

Herlev Hospital; Afdeling for Kræftbehandling, Herlev

3000

Peter MacCallum Cancer Centre; Medical Oncology, Melbourne

3112

Tauranga Hospital, Clinical Trials Unit; BOP Clinical School, Tauranga

3168

Monash Health Monash Medical Centre, Clayton

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

4010

Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie, Linz

4031

Universitätsspital Basel, Basel

4102

Princess Alexandra Hospital, Woolloongabba

5000

Odense Universitetshospital, Onkologisk Afdeling R, Odense C

5020

Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU, Salzburg

5037

Adelaide Cancer Centre, Kurralta Park

6008

St John of God Hospital; Bendat Cancer Centre, Subiaco

6020

Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie, Innsbruck

6021

Wellington Regional Hospital; Clinical Trials Unit, Wellington

6045

Cancercare, Port Elizabeth

6529

Cancercare, George

8091

Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie, Zurich

9000

AZ Maria Middelares, Ghent

9301

National Hospital; Oncotherapy Dept, Bloemfontein

10103

Clinica CIMCA, San José

10330

Chulalongkorn Hospital; Medical Oncology, Bangkok

10400

Rajavithi Hospital; Division of Medical Oncology, Bangkok

10408

National Cancer Center, Goyang-si

10700

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok

11001

Clinica del Country, Bogotá

12002

Hospital Provincial de Castellon; Servicio de Oncologia, Castellon

14029

Regional Oncology Center; Department of Mammology, Chernihiv

15006

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña

15088

Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel, Lima

20089

IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI)

21201

University of Maryland Medical Center, Baltimore

21202

Mercy Medical Center, Baltimore

21237

Medstar Franklin Square Medical Center, Baltimore

23040

Investigacion Oncofarmaceutica, La Paz

23900

ASST DI LECCO; Oncologia Medica, Lecco

25123

ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica, Brescia

27157

Wake Forest University Baptist Medical Center, Winston-Salem

28007

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28040

Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid

28050

Centro Integral Oncologico Clara Campal; Servicio de Oncología, Madrid

28222

Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda

29010

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Málaga

29414

Charleston Oncology, P .A, Charleston

30322

Winship Cancer Institute, Atlanta

31405

Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME, Savannah

33021

Memorial Healthcare System - Memorial Regional Hospital, Hollywood

33028

Memorial Cancer Institute at Memorial West, Pembroke Pines

33100

ASU FC S. M. DELLA MISERICORDIA; Oncologia, Udine

33308

Holy Cross Hospital, Fort Lauderdale

34214

Medipol University Medical Faculty; Oncology Department, Istanbul

35042

Centre Eugene Marquis; Service d'oncologie, Rennes

35128

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padua

36688

USA Mitchell Cancer Institute, Mobile

37203

Vanderbilt Univ Medical Ctr, Nashville

38138

The West Clinic; West Cancer Center, Germantown

39202

Jackson Oncology Associates, PLLC, Jackson

40000

Khonkaen Hospital, Khonkaen

40005

RCI Sumy Regional Clinical Oncological Dispensary, Sumy

41404

Kyungpook National University Medical Center, Daegu

46010

Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia

47014

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola

48106

St. Joseph Mercy Hospital; Cancer Care Center., Ann Arbor

48202

Henry Ford Health System, Detroit

49102

Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

50048

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department, Kryvyi Rih

50200

Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial, Chiang Mai

57100

Ospedale Civile; Unita Operativa Di Oncologia Medica, Livorno

60612

Rush University, Chicago

61018

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department, Kharkiv

64570

Christus Muguerza Clinica Vidriera, Monterrey

65025

Municipal Institution Odesa Regional Clinical Hospital, Odesa

65130

VAASAN KESKUSSAIRAALA; Onkologian poliklinikka, Vaasa

68803

CHI Health Saint Francis; Oncology, Grand Island

70121

Ochsner Health System, New Orleans

70210

KYS Sadesairaala; Syopatautien poliklinikka, Kuopio

70809

Ochsner Clinic Foundation, Baton Rouge

72762

Highlands Oncology Group, Springdale

80131

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli

80205

Kaiser Permanente - Franklin, Denver

90095

UCLA, Los Angeles

90110

Songklanagarind Hospital; Department of Oncology, Songkhla

92108

Kaiser Permanente-SCPMG; Oncology Research, San Diego

97227

Kaiser Permanente - Portland, Portland

97229

Oregon Health and Science University, Portland

111123

"SBIH Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva

115478

"Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF", Moskva

121467

University ?linic of headaches, Moscow

125284

P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept, Moscow

125367

FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy., Moskva

163045

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk

168583

National Cancer Centre; Medical Oncology, Singapore

197758

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint Petersburg

200347

Oncology Center Sf. Nectarie, Craiova

411028

Sahyadri Super Specialty Hospital Hadapsar, Pune

420029

Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan'

600004

Oncólogos de Occidente, Pereira

630005

"Limited Liability Company RC Medical", Novosibirsk

9103102

Shaare Zedek Medical Center, Jerusalem

94305-5820

Stanford Cancer Center, Stanford

06904

Stamford Hospital; BCC, MOHR, Stamford

03756

Dartmouth Hitchcock Medical Center, Lebanon

07601

Hackensack Univ Med Ctr, Hackensack

29605-4292

Greenville Health System; Cancer Center, Greenville

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

C1417DTB

Inst. Angel Roffo; Haematology, Buenos Aires

C1280AEB

Hospital Britanico, Ciudad Autonoma Bs As

X5800AEU

Instituto Medico Rio Cuarto, Córdoba

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

M5500AYB

Fundacion Scherbovsky, Mendoza

Unknown

Sunshine Hospital; Oncology Research, St Albans

Queen Mary Hospital; Dept of Medicine, Hong Kong

Tuen Mun Hospital; Clinical Onc, Hong Kong

Prince of Wales Hospital; Department of Clinical Onocology, Shatin

41253-190

Hospital Sao Rafael - HSR, Salvador

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

01317-001

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo

04014-002

Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA, São Paulo

T6G 1Z2

Cross Cancer Institute ; Dept of Medical Oncology, Edmonton

V3V 1Z2

Fraser Valley Centre British Columbia Cancer Agency, Surrey

R3E 0V9

Cancer Care Manitoba, Winnipeg

L4M 6M2

Royal Victoria Hospital, Barrie

K2H 6C2

The Ottawa Hospital Cancer Centre, Ottawa

H3T 1E2

Jewish General Hospital; Research Unit, Montreal

H4A 3J1

McGill University; Glen Site; Oncology, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

656 53

Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e, Brno

779 00

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc

00180

Docrates Cance Center, Helsinki

145 64

Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept., Kifissia

546 45

Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki

464-8681

Aichi Cancer Center Hospital, Aichi

960-1295

Fukushima Medical University Hospital, Fukushima

373-8550

Gunma Prefectural Cancer Center, Gunma

734-8551

Hiroshima University Hospital, Hiroshima

241-8515

Kanagawa Cancer Center, Kanagawa

862-8655

Kumamoto Shinto General Hospital, Kumamoto

700-8558

Okayama University Hospital, Okayama

541-8567

Osaka International Cancer Institute, Osaka

03100

Health Pharma Professional Research, Mexico City

04001

Centro Medico Monte Carmelo, Arequipa

04002

Instituto Regional de Enfermedades Neoplasicas, Arequipa

07016

Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion, Lima

Lima 34

Instituto Nacional de Enfermedades Neoplasicas, Lima

Lima 27

Clinica Ricardo Palma, San Isidro

93-338

Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej, ?ód?

44-101

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi, Gliwice

30-688

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Krakow

61-866

Wielkopolskie Centrum Onkologii, Poznan

02-781

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr, Warsaw

1500-650

Hospital da Luz; Departamento de Oncologia Medica, Lisbon

1649-035

Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon

2674-514

Hospital Beatriz Angelo; Departamento de Oncologia, Loures

4099-001

Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia, Porto

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

0001

Wilgers Oncology Centre, Pretoria

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

Seoul St Mary's Hospital, Seoul

08740

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de la Barca

08036

Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona

00112

VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei

06520

Memorial Ankara Hastanesi, Ankara

06230

Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara

04107

MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology, Kyiv

G12 0YN

BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1, Glasgow

SW3 6JJ

The Royal Marsden Hospital, Fulham, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04177108 - A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer | Biotech Hunter | Biotech Hunter