AzTrials
AzTrials

Triple Negative Breast CancerPhase 3IMpassion030NCT03498716

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

A Phase 3 study testing Atezolizumab, Paclitaxel and Dose-dense Doxorubicin or dose-dense Epirubicin in people with Triple Negative Breast Cancer, run by Hoffmann-La Roche at 364 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Atezolizumab, Paclitaxel and Dose-dense Doxorubicin or dose-dense Epirubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,199 participants
Where
364 sitesin 31 countries
Study dates
2 Aug 2018to 14 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-metastatic operable Stage II-III breast cancer
  • Histologically documented TNBC (Triple Negative Breast Cancer)
  • Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
  • Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
Show all 9Show fewer
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
  • No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
  • Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Who cannot join

  • Prior history of invasive breast cancer
  • For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
  • Previous therapy with anthracyclines or taxanes for any malignancy
  • Cardiopulmonary dysfunction
  • Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
  • Active or history of autoimmune disease or immune deficiency
Show all 12Show fewer
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Urinary outflow obstruction
  • Active tuberculosis
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
  • Prior allogeneic stem cell or solid organ transplant
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Trial locations and contacts

364 sites in 31 countries.

364 sites in 31 countries

France35 sites

  • Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

    Ars-Laquenexy, 57530

  • Institut Sainte Catherine

    Avignon, 84082

  • CH de Beauvais

    Beauvais, 60000

  • CHU Jean Minjoz

    Besançon, 25030

  • Clinique Tivoli; Sce Radiotherapie

    Bordeaux, 33000

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse, 01012

  • CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie

    Brest, 29609

  • CRLCC-Francois Baclesse; Oncologie Médicale

    Caen, 14076

  • CH de Cholet; oncologie

    Cholet, 49325

  • Centre Hospitalier de Compiegne

    Compiègne, 60321

  • Centre Hospitalier Alpes Leman

    Contamine-sur-Arve, 74130

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Centre Hospitalier Bretagne Sud

    Lorient, 56100

  • Hopital Prive Jean Mermoz

    Lyon, 69008

  • Hôpital Saint Joseph

    Marseille, 13008

  • Clinique Clémentville

    Montpellier, 34070

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • l'Hôpital privé du Confluent SAS

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • CH Annecy Genevois site Annecy; Oncologie

    Pringy, 74374

  • Chi De Cornouaille; Oncologie Hospitalisation

    Quimper, 29107

  • Institut Jean Godinot

    Reims, 51056

  • Institut du Cancer Coulancy Reims

    Reims, 51100

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut De Cancerologie Lucien Newrth

    Saint-Priest-en-Jarez, 42271

  • Centre Paul Strauss

    Strasbourg, 67000

  • Hopitaux Du Leman - Site Georges Pianta

    Thonon-les-Bains, 74200

  • Institut Claudius Régaud

    Toulouse, 31059

  • CHU Tours - Hôpital Bretonneau

    Tours, 37044

  • Hopital Prive Drome Ardeche; Hopital De Jour

    Valence, 26000

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy; Departement Oncologie Medicale

    Villejuif, 94805

Other trials in France

Spain30 sites

  • Centro Oncologico de Galicia COG; Medical Oncology

    A Coruña, LA Coruña, 15009

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital San Pedro De Alcantara; Servicio de Oncologia

    Cáceres, 10003

  • Hospital Provincial Castellón

    Castellon de LA Plana/castello de LA Plana, Castellon, 12002

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital de Jerez

    Jerez de la Frontera, Cadiz, 11407

  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia

    León, 24071

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28009

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal Ensayos Clínicos START

    Madrid, 28050

  • Hosp Univ Fundacion Alcorcon

    Madrid, 28922

  • Hospital Universitario de Fuenlabrada; Servicio de Oncologia

    Madrid, 28943

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28220

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

    Murcia, 30120

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Hospital Universitari Sant Joan de Reus; Planta baja, color lila

    Reus, Tarragona, 43204

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Infanta Sofia; Servico de Oncologia

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital General De Catalunya; Servicio de Oncologia

    Sant Cugat del Vallès, Barcelona, 28981

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Quirón Sagrado Corazón

    Seville, 41013

  • Consorci Hospitalari de Terrassa

    Terrassa, Barcelona, 08227

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 46014

  • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

    Vigo, Pontevedra, 36312

  • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

    Zaragoza, 50009

Other trials in Spain

China28 sites

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Hospital; Internal Medicine-Oncology

    Beijing, 100730

  • Beijing Union Hospital

    Beijing, 100730

  • The First Hospital of Jilin University

    Changchun, 130021

  • Jilin Cancer Hospital

    Changchun, 132013

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • The 900th Hospital of PLA joint service support force

    Fuzhou, 110016

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Sun yat-sen University Cancer Center; Internal Medicine of Oncology

    Guangzhou, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • Sun Yat-Sen University Cancer Center - Huangpu Campus

    Guangzhou

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003

  • The Second Affiliated Hospital of Zhejiang University College

    Hangzhou, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Shandong Cancer Hospital

    Jinan, 250117

  • Luoyang Central Hospital

    Luoyang, 471000

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

    Shanghai, 200025

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee

    Shenzhen, 518053

  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

    Shijiazhuang, 050035

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Russia27 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Evimed

    Chelyabinsk, Kurgan Oblast

  • Regional Oncology Hospital

    Irkutsk, 664035

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Medsi Clinic

    Moscow, Adygeya Republic, 143442

  • Moscow Clinical Scientific Center

    Moscow, Moscow Oblast, 111123

  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

    Moscow, Moscow Oblast, 115478

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moscow Oblast, 125248

  • Nizhny Novgorod Regional Clinical Oncology Center

    Nizhny Novgorod, Niznij Novgorod, 603126

  • Regional Oncology Dispensary; Dept of Chemotherapy

    Novgorod Veliky, 173016

  • BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic

    Omsk, 644013

  • Pyatigorsky Oncologic Dispensary

    Pyatigorsk, Stavropol Kray, 357524

  • National Medical Research Center for Oncology

    Rostov-on-Don, Rostov Oblast, 344037

  • LLC Strategic Medical Systems

    Saint Petersburg, Sankt-Peterburg, 194291

  • EosMed LLC

    Saint Petersburg, Sankt-Peterburg, 195197

  • Private Healthcare Institution Clinical Hospital RZhD Medicine

    Saint Petersburg, Sankt-Peterburg, 195271

  • LCC Center of Palliative Medicine - Devita

    Saint Petersburg, Sankt-Peterburg, 197343

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg, Sankt-Peterburg

  • Multidisciplinary clinic Reaviz

    Samara, 443011

  • Samara Regional Oncology Dispensary

    Samara, 443031

  • Mordovia State University

    Saransk, Respublika Mordoviya, 430032

  • Regional Clinical Hospital

    Saratov, 410053

  • Oncologica Dispensary #2

    Sochi, Krasnodarskiy Kray, 354057

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, Bashkortostan Republic, 450054

  • SHI Volgograd Regional Clinical Oncological Dispensary#1

    Volgograd, 400138

  • Regional Clinical Oncology Hospital

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Germany26 sites

  • Studienzentrum Berlin City

    Berlin, 14169

  • St. Elisabeth-Krankenhaus

    Cologne, 50935

  • St. Johannes-Hospital

    Dortmund, 44137

  • Onkozentrum Dres. Göhler

    Dresden, 01127

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 01307

  • Praxis für Hamatologie und Onkologie

    Erfurt, 99085

  • Onkodok GmbH

    Gütersloh, 33332

  • Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe

    Hamburg, 22457

  • Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard

    Hildesheim, 31134

  • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

    Karlsruhe, 76135

  • Klinikum Ludwigsburg; Studiensekretariat

    Ludwigsburg, 71640

  • St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

    Mainz, 55131

  • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

    Mainz, 55131

  • Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller

    Mayen, 56727

  • Klinikum Memmingen; Abt.Gynäkologie

    Memmingen, 87700

  • Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

    Minden, 32429

  • Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

    Mönchengladbach, 41061

  • Klinikum der Universität München; Frauenklinik - Onkologie II

    München, 80336

  • Klinikum Neumarkt; Frauenklinik

    Neumarkt in der Oberpfalz, 92318

  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

    Offenbach, 63069

  • Johanniter Frauenklinik Stendal Germany

    Stendal, 39676

  • Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

    Stralsund, 18439

  • Universitätsklinik Tübingen; Frauenklinik

    Tübingen, 72076

  • GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

    Weinheim, 69469

  • Marien-Hospital Witten, MVZ Witten

    Witten, 58452

  • Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

    Worms, 67550

Other trials in Germany

Italy22 sites

  • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

    Alessandria, Piedmont, 15121

  • Ospedale Santa Maria Annunziata; Oncologia

    Bagno a Ripoli, Tuscany, 50012

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, Abruzzo, 24060

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica

    Bologna, Emilia-Romagna, 40138

  • U.O Medicina Oncologica Ospedale di Carpi

    Carpi, Emilia-Romagna, 41012

  • Ospedale Degli Infermi - Faenza; Oncologia Medica

    Faenza, Emilia-Romagna, 48018

  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria, 16132

  • ASST DI LECCO; Oncologia Medica

    Lecco, Lombardy, 23900

  • Ospedale Mater Salutis

    Legnago (VR), Lombardy, 37045

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena, Emilia-Romagna, 41110

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Emilia-Romagna, 43126

  • Fondazione Salvatore Maugeri

    Pavia, Lombardy, 27100

  • Policlinico San Mattea

    Pavia, Lombardy, 27100

  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    Perugia, Umbria, 06100

  • Azienda Usl 7; Dept. Oncologico

    Poggibonsi, Tuscany, 53036

  • Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

    Ponderano (BI), Piedmont, 13875

  • Nuovo Ospedale Di Prato

    Prato, Tuscany, 50047

  • Ospedale degli Infermi

    Rimini, Emilia-Romagna, 47923

  • Policlinico Universitario Campus Biomedico Di Roma

    Rome, Lazio, 00128

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Japan22 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Chiba Cancer Center

    Chiba, 260-8717

  • Shikoku Cancer Center

    Ehime, 791-0280

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Sagara Hospital

    Kagoshima, 892-0833

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Fukushima Medical University Hospital

    Miyagi, 960-1295

  • Okayama University Hospital

    Okayama, 700-8558

  • Naha-nishi Clinic

    Okinawa, 901-0154

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • St. Luke's Internat. Hospital, Breast Surgical Oncology

    Tokyo, 104-8560

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

United States17 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Advocate Illinois Masonic Outpatient Center for Advanced Care

    Chicago, Illinois, 60657

  • John Muir Health Clinical Research Center

    Concord, California, 94520

  • Des Moines Oncology Research Association

    Des Moines, Iowa, 50309

  • Fairview Southdale Medical Oncology Clinic

    Edina, Minnesota, 55435

  • St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • HCA Midwest Division

    Kansas City, Missouri, 64132

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • New Hampshire Hematology Oncology

    Manchester, New Hampshire, 03103

  • SCRI

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11101

  • Rochester General Hospital; Lipson Cancer and Blood Center

    Rochester, New York, 14621

  • Intermountain Precision Genomics Cancer Research Clinic-Dixie

    St. George, Utah, 84770

  • Martin-O?Neil Cancer Center

    St. Helena, California, 94574

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

Other trials in United States

South Korea17 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Soon Chun Hyang University Cheonan Hospital

    Dongnam-gu, Cheonan-si, 31151

  • National Cancer Center

    Goyang-si, 10408

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital; Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

  • Ajou University Hospital

    Suwon, 443-721

  • Ulsan University Hosiptal

    Ulsan, 44033

  • Wonju Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Ukraine16 sites

  • Regional Oncology Center; Department of Mammology

    Chernihiv, 14029

  • Chernivtsi Regional Clinical Oncology Dispensary

    Chernivtsi, 58013

  • MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department

    Dnipro, KIEV Governorate, 49100

  • City Clinical Hospital #4

    Dnipropetrovsk, 49102

  • Municipal Institution Kirovograd Regional Oncology Dispensary

    Kirovograd, 25011

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

    Kryvyi Rih, 50048

  • Volyn Regional Oncology Dispensary

    Lutsk, 43018

  • Lviv State Oncological Regional Treatment and Diagnostic Center

    Lviv, 79031

  • Municipal Institution Odesa Regional Oncology Dispensary

    Odesa, KIEV Governorate, 65055

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

    Sumy, 40005

  • CCCH City Oncological Center SHEI Uzhgorod NU

    Uzhhorod, 88000

  • Transkarpathian Regional Oncology Clinic; Chemotherapy

    Uzhhorod, 88000

  • Vinnytsya Regional Clinical Oncology Dispensary

    Vinnytsia, Podolia Governorate, 21029

  • Yulis Medical and Diagnostic Center

    Zaporizhzhya, Katerynoslav Governorate, 69061

  • Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

    Zaporizhzhya, 69040

Other trials in Ukraine

Australia15 sites

  • Royal Adelaide Hospital; Cancer Centre

    Adelaide, South Australia, 5000

  • Icon Cancer Care Wesley

    Auchenflower, Queensland, 4066

  • Icon Cancer Foundation; Icon Cancer Care Chermside

    Chermside, Queensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Hospital Olivia Newton John Cancer Centre

    Heidelberg, Victoria, 3084

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2113

  • Maroondah Hospital; Breast Clinic

    Ringwood East, Victoria, 3135

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland, 4101

  • Mater Hospital; Cancer Services

    South Brisbane, Queensland, 4101

  • Icon Cancer Foundation; Icon Cancer Care Southport

    Southport, Queensland, 4215

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Princess Alexandra Hospital; Cancer Trials Unit

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil14 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-232

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-000

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Nucleo de Oncologia da Bahia - NOB

    Salvador, Bahia, Estado de Bahia, 40170-380

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650

  • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

    São Paulo, São Paulo, 01246 000

  • Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia

    São Paulo, São Paulo, 04014-002

  • Hospital Jardim Amália

    Volta Redonda, Rio de Janeiro, 27251-260

Other trials in Brazil

Taiwan10 sites

  • Chunghua Christian hospital

    Changhua, 500

  • E-Da Cancer Hospital; Hematology- Oncology Department

    Kaoshiung, 824

  • Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

    Kaoshiung City, 807

  • Chi Mei Medical Center Liou Ying Campus

    Liuying Township, 736

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital - Taipei Branch

    Taipei, 104

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Argentina9 sites

  • Centro de Oncologia e; Investigacion Buenos Aires - COIBA

    Berazategui, B1880BBF

  • INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology

    Ciudad Autonoma Buenos Aires, C1012AAR

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004FHP

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • Centro Medico San Roque

    San Miguel de Tucumán, T4000IAK

  • Fundación Ars Medica

    San Salvador de Jujuy

  • Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department

    Viedma, R8500ACE

Other trials in Argentina

Mexico9 sites

  • Iem-Fucam

    D.F., Mexico CITY (federal District), 04980

  • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

    Distrito Federal, Mexico CITY (federal District), 14000

  • Merida | Investigacion Clinica

    Mérida, Yucatán, 97125

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

    Mexico City, 03100

  • Centro Medico Dalinde

    Mexico City, 06700

  • Centro Médico Zambrano Hellion

    Monterrey, Nuevo León, 66278

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78209

Other trials in Mexico

Belgium8 sites

  • AZ KLINA

    Brasschaat, 2930

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHC MontLégia

    Liège, 4000

  • Chr de La Citadelle

    Liège, 4000

  • CHU Ambroise Paré

    Mons, 7000

  • Clinique Sainte-Elisabeth; Oncologie

    Namur, 5000

  • Vitaz

    Sint-Niklaas, 9100

Other trials in Belgium

Austria7 sites

  • Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn

    Innsbruck, 6020

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

    Linz, 4010

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

    Salzburg, 5020

  • AKH - Medizinische Universität Wien; Department of Oncology

    Vienna, 1090

  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

    Vienna, 1090

  • Salzkammergut-Klinikum Voecklabruck

    Vöcklabruck, 4840

  • Klinikum Kreuzschwestern Wels; Iv. Interne Abt.

    Wels, 4600

Other trials in Austria

Thailand7 sites

  • Rajavithi Hospital; Division of Medical Oncology

    Bangkok, 10400

  • Ramathibodi Hospital; Medicine/Oncology

    Bangkok, 10400

  • Siriraj Hospital; Clinical Research Center, Pharmacy Department

    Bangkok, 10700

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

  • Lampang Cancer Hospital

    Lampang, 52000

  • King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University

    Patumwan, 10330

Other trials in Thailand

United Kingdom6 sites

  • NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

    Edinburgh, EH4 2XU

  • Calderdale and Huddersfield NHS Foundation Trust

    Huddersfield, HD3 3EA

  • Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

    Leeds, LS9 7TF

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

  • University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Israel5 sites

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Med Org Kiryat; Oncology Institute

    Jerusalem, 9112000

  • Meir Medical center, Pediatrics

    Kfar Saba, 4428164

  • Rabin MC; Davidof Center - Oncology Institute

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Ramat Gan, 5211401

Other trials in Israel

Turkey (Türkiye)5 sites

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01240

  • Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

    Bursa, 16059

  • Izmir Ekonomi Universitesi Medical Park Hastanesi

    Izmir, 35575

  • Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

    Mersin, 33110

  • Medikal Park Samsun

    Samsun, 55200

Other trials in Turkey (Türkiye)

Poland4 sites

  • Instytut MSF Sp. z o.o.

    ?ód?, 90-302

  • MedPolonia

    Poznan, 60-693

  • Wielkopolskie Centrum Onkologi

    Poznan, 61-866

  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii

    Warsaw, 00-909

Other trials in Poland

Czechia3 sites

  • Nemocnice Horovice, NH Hospital a.s.; Oncology Department

    Hořovice, 26831

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

    Prague, 128 08

  • Krajska nemocnice T. Bati, a.s.

    Zlín, 76001

Other trials in Czechia

Denmark3 sites

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

  • Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

    Odense C, 5000

  • Sygehus Lillebælt, Vejle

    Vejle, 7100

Other trials in Denmark

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong, 999077

  • Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

    Hong Kong

  • Queen Elizabeth Hospital Department of Clinical Oncology

    Kowloon

Other trials in Hong Kong

Hungary3 sites

  • National Institute of Oncology, A Dept of Internal Medicine

    Budapest, 1122

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc, 3526

  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

    Pécs, 7623

Other trials in Hungary

Peru3 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

    Arequipa, 04001

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038

  • Oncosalud Sac; Oncología

    Lima, 41

Other trials in Peru

Romania3 sites

  • "Filantropia" Clinical Hospital; Gynecological Oncology

    Bucharest, 011191

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347

Other trials in Romania

Switzerland3 sites

  • Hirslanden Medical Center - Tumorzentrum

    Aarau, 5000

  • Centre Hospitalier Universitaire Vaudois - Lausanne

    Lausanne, 1011

  • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

    Zurich, 8008

Other trials in Switzerland

Ireland2 sites

  • Mater Misecordiae University Hospital

    Dublin, 7

  • Beaumont Hospital; Cancer Clinical Trials Unit

    Dublin, 9

Other trials in Ireland

Singapore2 sites

  • National University Hospital; Medical Oncology

    Singapore, 119074

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Being tested
Atezolizumab, Paclitaxel, Dose-dense Doxorubicin or dose-dense Epirubicin, Cyclophosphamide
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses.

    Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year

  • PaclitaxelDrug

    Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.

  • Dose-dense Doxorubicin or dose-dense EpirubicinDrug

    Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses.

    Or

    Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses

  • CyclophosphamideDrug

    Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses

Study groups in NCT03498716
Study groupRoleWhat they receive
Atezolizumab + ChemotherapyExperimentalParticipants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Receives: Drug: Atezolizumab; Drug: Paclitaxel; Drug: Dose-dense Doxorubicin or dose-dense Epirubicin; Drug: Cyclophosphamide
ChemotherapyActive comparatorChemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Receives: Drug: Paclitaxel; Drug: Dose-dense Doxorubicin or dose-dense Epirubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive Disease-Free Survival (iDFS)

    iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

    Measured: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)

Secondary outcomes (13)

  1. Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)

    iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

    Measured: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)

  2. Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation

    iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

    Measured: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)

  3. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

    Measured: From randomization up to death from any cause (up to 5 years)

  4. Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer

    iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than sites mentioned]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

    Measured: From randomization up to death from any cause (up to 5 years)

  5. Recurrence-Free Interval (RFI)

    Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional [including invasive ipsilateral tumor and invasive locoregional tumor], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.

    Measured: From randomization up to 5 years

  6. Distant Recurrence-Free Interval (DRFI)

    Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.

    Measured: From randomization up to 5 years

  7. Disease-Free Survival (DFS)

    Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

    Measured: From randomization up to first disease recurrence or death from any cause (up to 5 years)

  8. Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7])

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement.

    Measured: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles

  9. Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.

    Measured: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles

  10. Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

    Measured: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles

  11. Number of Participants With Adverse Events (AE)

    An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

    Measured: Up to 5 years

  12. Serum Concentration of Atezolizumab

    Measured: Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles

  13. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

    Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start2 Aug 2018
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Why it stopped: The study was terminated by the sponsor following interim analysis as the primary endpoint of iDFS crossed the pre-specified futility boundary of hazard ratio \> 1 in the Intent-to-Treat (ITT) population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03498716
Sponsor's protocol ID
WO39391
Other IDs
2016-003695-47, BIG 16-05, AFT-27, ALEXANDRA, 2016
Acronym
IMpassion030
Status last verified
Jul 2024
First submitted
28 Feb 2018
Last updated
21 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ignatiadis M, Bailey A, McArthur H, El-Abed S, de Azambuja E, Metzger O, Chui SY, Dieterich M, Perretti T, Shearer-Kang E, Molinero L, Steger GG, Jassem J, Lee SC, Higgins M, Zarba J, Schmidt M, Gomez H, Guerrero Zotano A, Moscetti L, Chiu J, Munzone E, Ben-Baruch NE, Bajetta E, Ohno S, Im SA, Werutsky G, Gal-Yam EN, Gonzalez Farre X, Tseng LM, Jacot W, Gluz O, Shao Z, Shparyk Y, Zimina A, Winer E, Cameron DA, Viale G, Saji S, Gelber R, Piccart M. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial. JAMA. 2025 Jan 30;333(13):1150-60. doi: 10.1001/jama.2024.26886. Online ahead of print.

    PubMed 39883436

  • Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.

    PubMed 32450725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Paclitaxel and Dose-dense Doxorubicin or dose-dense Epirubicin in people with Triple Negative Breast Cancer, run by Hoffmann-La Roche at 364 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 364 sites in France, Spain, China, Russia, Germany and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease-Free Survival (iDFS) (time frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03498716, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in