A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

595

Participants

Timeline

Start Date

January 11, 2018

Primary Completion Date

October 23, 2024

Study Completion Date

October 23, 2024

Conditions
Triple Negative Breast Neoplasms
Interventions
DRUG

Atezolizumab

"Atezolizumab will be administered, 1200 mg by IV infusion with :~gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle"

DRUG

Placebo

"Placebo will be administered, 1200 mg by IV infusion with :~gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle"

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle

DRUG

Capecitabine

Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

DRUG

Carboplatin

Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle

Trial Locations (136)

1032

Szent Margit Hospital, Budapest

1122

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest

1145

Budapesti Uzsoki Utcai Kórház, Budapest

2193

Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg

2196

Medical Oncology Centre of Rosebank; Oncology, Johannesburg

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez, Miskolc

6213

Institut National D'oncologie Sidi Med Benabdellah, Rabat

7623

Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs

10060

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo

10300

Hospital Hermanos Ameijeiras, La Habana

10400

Instituto Nacional de Oncología y Radiología (INOR), La Habana

11000

Institute of Oncology and Radiology of Serbia, Belgrade

11080

University Hospital Medical Center Bezanijska kosa, Belgrade

13273

Institut Paoli-Calmettes; Oncologie Medicale 1, Marseille

14080

Instituto Nacional de Cancerologia; Oncology, Mexico City

15038

Instituto Nacional de Enfermedades Neoplasicas, Lima

15213

Magee-Woman's Hospital, Pittsburgh

16132

Azienda Ospedaliero Universitaria San Martino, Genoa

17109

Magee-Woman's Hospital; UPMC Pinnacle Cancer Center, Harrisburg

18000

Clinical Centre Nis, Clinic for Oncology, Niš

20132

Ospedale San Raffaele S.r.l., Milan

20141

Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica, Milan

20900

Ospedale San Gerardo, Monza

21034

Centre Georges-François Lecler; Ctr de Lutte Contre le Canc, Dijon

21204

Oncology Institute of Vojvodina, Kamenitz

22030

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne

22042

Inova Schar Cancer Institute, Falls Church

28009

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

29010

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

30000

Centre Hospitalier Universitaire Hassan II, Fes

30625

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hanover

33520

Tampere University Hospital; Dept of Oncology, Tampere

33705

Florida Cancer Specialists & Research Institute, St. Petersburg

33901

Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers

34214

Medipol University Medical Faculty; Oncology Department, Istanbul

34298

Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque, Montpellier

34890

Marmara University Pendik Training and Research Hospital; Medikal Onkoloji, Istanbul

35042

Centre Eugene Marquis; Service d'oncologie, Rennes

35100

Ege University Medical Faculty; Medical Oncology Department, Bornova, ?zm?r

35128

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padua

37203

SCRI Oncology Partners, Nashville

40000

Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie, Marrakesh

Clinique specialise Menara; Oncology Medical, Marrakesh

42080

Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases, Konya

45136

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen

46010

Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia

48903

Hospital de Cruces; Servicio de Oncologia, Bilbao

50134

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia, Florence

54519

Centre Alexis Vautrin; Oncologie Medicale, Vandœuvre-lès-Nancy

65929

Varisano Klinikum Frankfurt Höchst GmbH, Frankfurt

69120

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg

69373

Centre Leon Berard; Oncologie Genetique, Lyon

71000

Clinical center University of Sarajevo, Sarajevo

72100

Ospedale Antonio Perrino; Oncologia Medica, Brindisi

78000

University Clinical Center of the Republic of Srpska, Banja Luka

80131

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

80639

Medizinisches Zentrum für Hämatologie und Onkologie, München

81000

Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy, Podgorica

92210

INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale., Saint-Cloud

94800

IGR, Villejuif

100021

Cancer Hospital , Chinese Academy of Medical, Beijing

100044

Peking University People's Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

111123

Moscow Clinical Scientific Center, Moscow

115478

"FSBI National Medical Research Center of Oncology N.N. Blokhin?", Moscow

121001

The First Affiliated Hospital Of Jinzhou Medical University, Jinzhou

132013

Jilin Cancer Hospital, Changchun

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

150081

Harbin Medical University Cancer Hospital, Harbin

168583

National Cancer Centre; Medical Oncology, Singapore

195271

Private Healthcare Institution Clinical Hospital RZhD Medicine, Saint Petersburg

198255

City Clinical Oncology Dispensary, SPb SBIH CCOD, Saint Petersburg

201315

Fudan University Shanghai Cancer Center; Medical Oncology, Shanghai

210008

Jiangsu Province Hospital, Nanjing

233000

the First Affiliated Hospital of Bengbu Medical College, Bengbu

250117

Shandong Cancer Hospital, Jinan

266003

The Affiliated Hospital of Medical College Qingdao University, Qingdao

300060

Tianjin Cancer Hospital, Tianjin

310016

Sir Run Run Shaw Hospital Zhejiang University, Hangzhou

310022

Zhejiang Cancer Hospital, Zhejiang

350001

Fujian Medical University Union Hospital, Fuzhou

400016

The First Affiliated Hospital, Chongqing Medical University, Chongqing

510000

Sun Yat-sen Memorial Hospital, Guangzhou

710032

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital), Xi'an

2520598

ONCOCENTRO APYS; Oncología, Viña del Mar

4800827

James Lind Centro de Investigación Del Cáncer, Temuco

5480000

Patagonia Research, Port Montt

7500921

Fundacion Arturo Lopez Perez, Santiago

8241479

Clinica Vespucio, Santiago

8420383

Bradford Hill Centro de Investigaciones Clinicas, Recoleta

07652

The Valley Hospital, Paramus

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

S2000KZE

Instituto de Oncología de Rosario, Rosario

S2002KDS

Hospital Provincial del Centenario, Rosario

60135-237

Oncocentro Serviços Medicos E Hospitalares Ltda, Fortaleza

74605-070

Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia

50040-000

Hospital do Cancer de Pernambuco - HCP, Recife

99010-090

Hospital Sao Vicente de Paulo, Passo Fundo

90040-373

Hospital Nossa Senhora da Conceicao, Porto Alegre

89812-211

Centro de Oncologia de Santa Catarina LTDA, Chapecó

01229-010

Instituto de Pesquisa Grupo NotreDame Intermedica, São Paulo

01317-000

Hospital Perola Byington, São Paulo

04014-002

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

050035

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang

030013

Shanxi Province Cancer Hospital, Taiyuan

00029

Helsinki University Central Hospital; Dept of Oncology, Helsinki

01307

"Universitätsklinikum Carl Gustav Carus; Frauenheilkunde und Geburtshilfe", Dresden

06120

Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie, Halle

050022

Kazakh Scientific Research Institution Of Oncology and Radiology, Almaty

06760

Centro Medico Dalinde, Mexico City

03100

CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO, Mexico City

0832

The Panama Clinic, Panama City

25-734

?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii, Kielce

02-781

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warsaw

1649-035

Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon

4099-001

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

Unknown

"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg

0081

Private Oncology Centre, Pretoria

463-707

Seoul National University Bundang Hospital, Seongnam-si

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron; Oncology, Barcelona

06100

Hacettepe University Medical Faculty; Department of Internal Medicine, Ankara

06200

Ankara Oncology Hospital; Medical Oncology Department, Ankara

CF14 2TL

Velindre Cancer Centre; Oncology Dept, Cardiff

CV2 2DX

University Hospital Coventry, Coventry

EH4 2XU

Western General Hospital; Edinburgh Cancer Center, Edinburgh

LA1 4RP

Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust, Lancaster

EC1M6BQ

Barts, London

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

M20 4BX

Christie Hospital NHS Trust, Manchester

HA6 2RN

Mount Vernon Cancer Centre, Northwood

ST4 6QG

Royal Stoke University Hospital, Stoke-on-Trent

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03371017 - A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer | Biotech Hunter | Biotech Hunter