AzTrials
AzTrials

Breast CancerPhase 3AstefaniaNCT04873362

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

A Phase 3 study testing Atezolizumab, Trastuzumab Emtansine and Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 238 sites in 32 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Atezolizumab, Trastuzumab Emtansine and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,188 participants
Where
238 sitesin 32 countries
Study dates
4 May 2021to 2 Oct 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed invasive breast carcinoma
  • Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
  • Centrally confirmed PD-L1 and hormone receptor status
  • Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
  • Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
  • <=12 weeks between primary surgery and randomization
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%
  • Life expectancy >= 6 months
  • Adequate hematologic and end organ function

Who cannot join

  • Stage IV breast cancer
  • An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
  • Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
  • History of exposure to various cumulative doses of anthracyclines
  • History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
  • Current grade >=2 peripheral neuropathy
Show all 11Show fewer
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
  • History of or active autoimmune disease or immune deficiency
  • Treatment with immunostimulatory or immunosuppressive agents
  • Cardiopulmonary dysfunction
  • Any known active liver disease

Trial locations and contacts

238 sites in 32 countries.

238 sites in 32 countries

United States22 sites

  • Alabama Oncology

    Birmingham, Alabama, 35205

  • Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center

    Buena, California, 91505

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Carrollton, Georgia, 30117

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Hematology Oncology Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22408

  • The West Clinic

    Germantown, Tennessee, 38138

  • University of Iowa

    Iowa City, Iowa, 52242-1086

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336-7774

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916-2305

  • Virginia Oncology Associates - New Port News

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

    Philadelphia, Pennsylvania, 19106

  • Virginia Cancer Institute

    Richmond, Virginia, 23229

  • Mays Cancer Center at UT Health San Antonio MD Anderson Cancer

    San Antonio, Texas, 78229

  • UCLA Medical Center

    Santa Monica, California, 90404

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Virginia Oncology Associates - Virginia Beach

    Virginia Beach, Virginia, 23456

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • New England Cancer Specialists

    Westbrook, Maine, 04092

  • Innovation Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Germany19 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Hochwaldkrankenhaus

    Bad Nauheim, 61231

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Gynäkologisches Zentrum Bonn

    Bonn, 53111

  • Knappschaft Kliniken Marienhospital Bottrop

    Bottrop, 46236

  • Städtisches Klinikum Dessau

    Dessau, 06847

  • Gynonco Düsseldorf, MVZ Medical Center GmbH

    Düsseldorf, 40235

  • Frauenarztpraxis Dr. Apel, Dr. Kolpin

    Erfurt, 99084

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

    Essen, 45136

  • AGAPLESION Markus-Krankenhaus

    Frankfurt, 60431

  • Klinik Johann Wolfgang von Goethe Uni

    Frankfurt, 60596

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Diakovere Henriettenstift, Frauenklinik

    Hanover, 30171

  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

    Kiel, 24105

  • Städtische Klinik Lüneburg

    Lüneburg, 21339

  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

    München, 80336

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

  • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

    Schweinfurt, 97422

  • Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen

    Westerstede, 26655

Other trials in Germany

Spain19 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

  • Hospital Juan Ramon Jimenez

    Huelva, 21005

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007

  • Hospital de Jerez de la Frontera

    Jerez de la Frontera, Cadiz, 11407

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Quiron de Madrid

    Madrid, 28223

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Turkey (Türkiye)16 sites

  • Adana Baskent University Hospital

    Adana, 01120

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Ankara Bilkent City Hospital

    Ankara, 06490

  • Gazi University Medical Faculty, Oncology Hospital

    Ankara, 06500

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Antalya Training and Research Hospital

    Antalya, 07100

  • Ege University Medical Faculty

    Bornova, ?zm?r, 35100

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280

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

    Edirne, 22030

  • Istanbul Faculty of Medicine

    Istanbul, 34093

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34098

  • Medeniyet University Goztepe Training and Research Hospital.

    Istanbul, 34730

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360

  • Inonu University Medical Faculty of Medicine

    Malatya, 44280

  • Medical Park Seyhan Hospital

    Seyhan, 01140

  • Ac?badem Altunizade Hastanesi

    Üsküdar, 34662

Other trials in Turkey (Türkiye)

China13 sites

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital - Sichuan University

    Chengdu, 610047

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510000

  • Guangdong Provincial People's Hospital

    Guangzhou, 510245

  • The First Affilicated Hospital, Sun Yat-sen University

    Guangzhou

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, DUMMY_VALUE

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

    Wuhan, 430022

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Russia13 sites

  • SBIH Kaluga Region Clinical Oncology Dispensary

    Kaluga, 248007

  • Republican Clinical Oncological Dispensary of the Ministry of Healthcare

    Kazan, Republic of Karelia, 420029

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

    Moscow, Moscow Oblast, 115478

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422

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

    Moskva, Moscow Oblast, 111123

  • Nizhny Novgorod Regional Clinical Oncology Center

    Nizhny Novgorod, Niznij Novgorod, 603126

  • LLC Medical and Sanitary Unit "Clinician"

    Novosibirsk, 630099

  • SBI of Healthcare Leningrad Regional Oncology Dispensary

    Saint Peterburg, Sankt-Peterburg, 191104

  • Medical Clinic "AB Medical group"

    Saint Petersburg, Sankt-Peterburg, 196006

  • FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • Regional Oncology Dispensary

    Tomsk, 634063

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

France12 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • CHRU Besançon

    Besançon, 25030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CHU Brest Hopital La Cavale Blanche

    Brest, 29609

  • Centre Francois Baclesse

    Caen, 14076

  • Groupe Hospitalier Public Du Sud De L'Oise GHPSO

    Creil, 60109

  • CLCC Leon Berard Lyon

    Lyon, 69008

  • Centre Hospitalier Uni Ire Caremeau

    Nîmes, 30029

  • Groupe Hospitalier Diaconesses

    Paris, 75020

  • Institut Curie

    Paris, 75231

  • Pole Regional De Cancerologie

    Poitiers, 86021

  • HOPITAL RENE HUGUENIN, Institut Curie

    Saint-Cloud, 92210

Other trials in France

United Kingdom12 sites

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN

  • Barts & London School of Med

    London, EC1A 7BE

  • University College London Hospital

    London, NW1 - 2PG

  • Royal Free Hospital

    London, NW3 2QS

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

Italy11 sites

  • AORN'S.G.Moscati

    Avellino, Campania, 83100

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123

  • Ospedale Civile - Livorno

    Livorno, Tuscany, 57124

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • A.O. Universitaria Policlinico Di Modena

    Modena, Emilia-Romagna, 41100

  • U.O.C. Oncologia Medica Senologica

    Naples, Campania, 80131

  • Università degli Studi Federico II

    Naples, Campania, 80131

  • Azlenda Ospendaliero-Universitaria Pisana

    Pisa, Tuscany, 56100

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

Brazil10 sites

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001

  • Núcleo de Pesquisa São Camilo

    São Paulo, São Paulo, 03102-002

Other trials in Brazil

South Korea10 sites

  • Kyungpook National University Medical Center

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Samsung Medical Center

    Seoul, (0)6351

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

India9 sites

  • Hemato Oncology Clinic Ahmedabad Pvt Ltd

    Ahmedabad, Gujarat, 380054

  • Manipal Hospital

    Bangalore, Karnataka, 560017

  • TATA Medical Centre

    Kolkata, West Bengal, 700156

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422002

  • Rajiv Gandhi Cancer Institute & Research Center

    New Delhi, National Capital Territory of Delhi, 110085

  • Max Super Speciality Hospital

    North WEST Delhi, National Capital Territory of Delhi, 110088

  • Sahyadri Super Specialty Hospital Hadapsar

    Pune, Maharashtra, 411028

  • Christian Med Clg & Hspt

    Ratnagiri Kilminnal, Tamil Nadu, 632517

Other trials in India

Czechia6 sites

  • Masaryk?v onkologický ústav

    Brno, 656 53

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, 741 01

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice

    Prague, 128 08

  • Fakultni Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Greece6 sites

  • Anticancer Hospital Ag. Savas

    Athens, 115 22

  • Alexandras General Hospital of Athens

    Athens, 115 28

  • University General Hospital of Heraklion

    Crete, 711 10

  • University Hospital of Larissa

    Larissa, 411 10

  • Metropolitan Hospital

    Piraeus, 185 47

  • European Interbalkan Medical Center

    Thessaloniki, 570 01

Other trials in Greece

Mexico6 sites

  • Instituto Nacional De Cancerologia

    Distrito Federal, Mexico CITY (federal District), 14000

  • Investigacion Oncofarmaceutica

    La Paz, Baja California Sur, 23040

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Centro Medico Dalinde

    Mexico City, Mexico CITY (federal District), 06760

  • Filios Alta Medicina

    Monterrey, Nuevo León, 64460

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

Other trials in Mexico

Poland6 sites

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

  • Narodowy Instytut Onkologii Odzia? w Gliwicach

    Gliwice, 44-102

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

  • Centrum Onkologii Instytut im.M. Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Romania6 sites

  • Filantropia Clinical Hospital

    Bucharest, 021164

  • Amethyst Cluj

    Cluj County, 407280

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, 400006

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Ukraine6 sites

  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

    Dnipropetrovsk, 49102

  • Municipal Noncommercial Institution Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070

  • Municipal Institution Kirovograd Regional Oncology Dispensary

    Kirovograd, 25011

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

    Sumy, Kholm Governorate, 40005

  • Uzhgorod Central City Clinical Hospital

    Uzhhorod, Katerynoslav Governorate, 88000

Other trials in Ukraine

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung Uni Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 00112

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 104

Other trials in Taiwan

Portugal4 sites

  • Hospital CUF Tejo

    Lisbon, 1350-352

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Beatriz Angelo

    Loures, 2674-514

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

Thailand4 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Australia3 sites

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Austria3 sites

  • Tiroler Landeskrankenanstalten Ges.M.B.H.

    Innsbruck, 6020

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010

  • Lkh Salzburg - Univ. Klinikum Salzburg

    Salzburg, 5020

Other trials in Austria

Belgium3 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • Clinique St. Elizabeth

    Namur, 5000

Other trials in Belgium

Bulgaria3 sites

  • COC Plovdiv

    Plovdiv, 4004

  • Medical Center "Nadezhda Clinical" EOOD

    Sofia, 1330

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

Other trials in Bulgaria

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong, 852

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Hungary3 sites

  • Budapesti Szent Margit Korhaz

    Budapest, 1032

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

Other trials in Hungary

Denmark1 site

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Kenya1 site

  • The Aga Khan University-Kenya.

    Nairobi, 00100

Other trials in Kenya

New Zealand1 site

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023

Other trials in New Zealand

Singapore1 site

  • National Cancer Centre

    Singapore, 168583

Other trials in Singapore

Uganda1 site

  • Uganda Cancer Institute

    Kampala, 00256

Other trials in Uganda

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

As of June 4, 2024, this study is no longer accepting any newly screened participants.

Conditions
Breast Cancer
Being tested
Atezolizumab, Trastuzumab Emtansine, Placebo, Trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • AtezolizumabDrug

    Also called Tecentriq, RO5541267, MPDL3280A

    Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.

  • Trastuzumab EmtansineDrug

    Also called Kadcyla, T-DM1, RO5304020

    Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.

  • PlaceboDrug

    Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.

Study groups in NCT04873362
Study groupRoleWhat they receive
Arm A: Placebo + Trastuzumab EmtansineActive comparatorParticipants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.
Receives: Drug: Trastuzumab Emtansine; Drug: Placebo; Drug: Trastuzumab
Arm B: Atezolizumab + Trastuzumab EmtansineExperimentalParticipants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.
Receives: Drug: Atezolizumab; Drug: Trastuzumab Emtansine; Drug: Trastuzumab

What is being measured

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

  1. Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS)

    IDFS event is defined as the time from randomization to the first occurrence of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, death from any cause.

    Measured: From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 years)

Secondary outcomes (18)

  1. IDFS Including Second Primary Non-breast Invasive Cancer

    Measured: From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from last participant in [LPI])

  2. IDFS in the PD-L1-positive and the PD-L1-negative Population

    Defined as all randomized participants from the ITT population with a centrally assessed PD-L1-positive [i.e., PD-L1 status of IC1/2/3] or PD-L1-negative status [i.e.,PD-L1 status of IC0] at randomization as per corresponding stratification factors recorded in the interactive web-based response system (IWRS).

    Measured: From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from LPI)

  3. Disease-free Survival (DFS)

    Measured: From baseline until the first occurrence of DFS event or death, through the end of study (approximately 10 years from LPI)

  4. Overall Survival (OS)

    Measured: From baseline to death from any cause through the end of study (approximately 10 years from LPI)

  5. Distant Recurrence-free Interval (DRFI)

    Measured: From baseline until distant disease recurrence, through the end of study (approximately 10 years from LPI)

  6. Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function

    Clinically Meaningful Deterioration will be Measured by Scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ C30)

    Measured: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)

  7. Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30

    The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.

    Measured: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)

  8. Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30

    The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.

    Measured: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)

  9. Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

    Measured: From baseline up to 10 years

  10. Maximum Serum Concentrations (Cmax) for Atezolizumab

    Measured: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)

  11. Minimum Serum Concentrations (Cmin) for Atezolizumab

    Measured: Pre-infusion on Day 1 of Cycles 1, 2, 3, 4 and 8 (a cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

  12. Cmax for Trastuzumab Emtansine

    Measured: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)

  13. Cmin for Trastuzumab Emtansine

    Measured: Pre-infusion on Day 1 of Cycles 1 and 4 (a cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

  14. Cmax for Total Trastuzumab

    Measured: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)

  15. Cmin for Total Trastuzumab

    Measured: Pre-infusion on Day 1 of Cycles 1 and 4 (a cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

  16. Cmax for DM1

    DM1 = a thiol-containing maytansinoid anti-microtubule agent; N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine

    Measured: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)

  17. Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab

    Measured: Pre-infusion on Day 1 of Cycles 1, 2, 3, 4 and 8 (a cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

  18. Percentage of Participants with ADAs to Trastuzumab Emtansine

    Measured: Pre-infusion on Day 1 of Cycles 1 and 4 (a cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

Timeline

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

  1. First posted5 May 2021
  2. Study start4 May 2021
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion2 Oct 2034 (estimated)

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873362
Sponsor's protocol ID
WO42633
Other IDs
2020-003681-40, 2023-503568-18-00, 2023
Acronym
Astefania
Status last verified
Sep 2026
First submitted
21 Apr 2021
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Hurvitz SA, Bachelot T, Bianchini G, Harbeck N, Loi S, Park YH, Prat A, Gilham L, Boulet T, Gochitashvili N, Monturus E, Lambertini C, Nyawira B, Knott A, Restuccia E, Schmid P. ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer. Future Oncol. 2022 Oct;18(32):3563-3572. doi: 10.2217/fon-2022-0485. Epub 2022 Nov 16.

    PubMed 36382554

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Trastuzumab Emtansine and Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 238 sites in 32 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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 238 sites in United States, Germany, Spain, Turkey (Türkiye), China and 27 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?

This study is still under way. Results are not available in the source record yet.

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) in the Full Analysis Set (FAS) (time frame: From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 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 NCT04873362, which also lists 1 linked publication.

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 3 Sep 2026.

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