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 (Astefania)

March 2, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1188

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.
      • Linz, Austria, 4010
        • Ordensklinikum Linz Barmherzige Schwestern
      • Salzburg, Austria, 5020
        • Lkh Salzburg - Univ. Klinikum Salzburg
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Hasselt, Belgium, 3500
        • Jessa Zkh (Campus Virga Jesse)
      • Namur, Belgium, 5000
        • Clinique St. Elizabeth
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-550
        • Crio - Centro Regional Integrado de Oncologia
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brazil, 01317-001
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
      • São Paulo, São Paulo, Brazil, 03102-002
        • Núcleo de Pesquisa São Camilo
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • COC Plovdiv
      • Sofia, Bulgaria, 1527
        • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
      • Sofia, Bulgaria, 1330
        • Medical Center "Nadezhda Clinical" EOOD
  • China
      • Chengdu, China, 610041
        • Sichuan Cancer Hospital
      • Chengdu, China, 610047
        • West China Hospital - Sichuan University
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Guangzhou, China, 510000
        • Sun Yat-Sen Memorial Hospital
      • Guangzhou, China
        • The First Affilicated Hospital, Sun Yat-sen University
      • Guangzhou, China, 510245
        • Guangdong Provincial People's Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
      • Wuhan, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xi'an, China, 710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Czechia
      • Brno, Czechia, 656 53
        • Masaryk?v onkologický ústav
      • Hradec Králové, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove
      • Nový Jičín, Czechia, 741 01
        • Nemocnice AGEL Nový Jičín a.s.
      • Olomouc, Czechia, 779 00
        • Fakultni Nemocnice Olomouc
      • Prague, Czechia, 128 08
        • Fakultni Poliklinika Vseobecne Fakultni Niemocnice
      • Praha 4 - Krc, Czechia, 140 59
        • Fakultni Thomayerova nemocnice
  • Denmark
      • Vejle, Denmark, 7100
        • Vejle Sygehus
  • France
      • Avignon, France, 84918
        • Institut Sainte Catherine
      • Besançon, France, 25030
        • CHRU Besançon
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Brest, France, 29609
        • CHU Brest Hopital la Cavale Blanche
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Creil, France, 60109
        • Groupe Hospitalier Public Du Sud De L'Oise GHPSO
      • Lyon, France, 69008
        • CLCC Leon Berard Lyon
      • Nîmes, France, 30029
        • Centre Hospitalier Uni Ire Caremeau
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses
      • Paris, France, 75231
        • Institut Curie
      • Poitiers, France, 86021
        • Pole Regional De Cancerologie
      • Saint-Cloud, France, 92210
        • HOPITAL RENE HUGUENIN, Institut Curie
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Bad Nauheim, Germany, 61231
        • Hochwaldkrankenhaus
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Bonn, Germany, 53111
        • Gynäkologisches Zentrum Bonn
      • Bottrop, Germany, 46236
        • Knappschaft Kliniken Marienhospital Bottrop
      • Dessau, Germany, 06847
        • Städtisches Klinikum Dessau
      • Düsseldorf, Germany, 40235
        • Gynonco Düsseldorf, MVZ Medical Center GmbH
      • Erfurt, Germany, 99084
        • Frauenarztpraxis Dr. Apel, Dr. Kolpin
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
      • Frankfurt, Germany, 60431
        • AGAPLESION Markus-Krankenhaus
      • Frankfurt, Germany, 60596
        • Klinik Johann Wolfgang von Goethe Uni
      • Freiburg im Breisgau, Germany, 79110
        • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
      • Hanover, Germany, 30171
        • Diakovere Henriettenstift, Frauenklinik
      • Kiel, Germany, 24105
        • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
      • Lüneburg, Germany, 21339
        • Städtische Klinik Lüneburg
      • München, Germany, 80336
        • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann
      • Schweinfurt, Germany, 97422
        • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen
  • Greece
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag. Savas
      • Athens, Greece, 115 28
        • Alexandras General Hospital of Athens
      • Crete, Greece, 711 10
        • University General Hospital of Heraklion
      • Larissa, Greece, 411 10
        • University Hospital of Larissa
      • Piraeus, Greece, 185 47
        • Metropolitan Hospital
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1032
        • Budapesti Szent Margit Korhaz
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380054
        • Hemato Oncology Clinic Ahmedabad Pvt Ltd
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial hospital
      • Nashik, Maharashtra, India, 422002
        • HCG Manavata Cancer Centre
      • Pune, Maharashtra, India, 411028
        • Sahyadri Super Specialty Hospital Hadapsar
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute & Research Center
      • North WEST Delhi, National Capital Territory of Delhi, India, 110088
        • Max Super Speciality Hospital
    • Tamil Nadu
      • Ratnagiri Kilminnal, Tamil Nadu, India, 632517
        • Christian Med Clg & Hspt
    • West Bengal
      • Kolkata, West Bengal, India, 700156
        • Tata Medical Centre
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
        • AORN'S.G.Moscati
      • Napoli, Campania, Italy, 80131
        • U.O.C. Oncologia Medica Senologica
      • Napoli, Campania, Italy, 80131
        • Università degli Studi Federico II
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • A.O. Universitaria Policlinico Di Modena
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO)
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Asst Degli Spedali Civili Di Brescia
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int)
    • Tuscany
      • Livorno, Tuscany, Italy, 57124
        • Ospedale Civile - Livorno
      • Pisa, Tuscany, Italy, 56100
        • Azlenda Ospendaliero-Universitaria Pisana
  • Kenya
      • Nairobi, Kenya, 00100
        • The Aga Khan University-Kenya.
  • Mexico
    • Baja California Sur
      • La Paz, Baja California Sur, Mexico, 23040
        • Investigacion Oncofarmaceutica
    • Mexico CITY (federal District)
      • Distrito Federal, Mexico CITY (federal District), Mexico, 14000
        • Instituto Nacional De Cancerologia
      • Mexico City, Mexico CITY (federal District), Mexico, 03100
        • Health Pharma Professional Research
      • Mexico City, Mexico CITY (federal District), Mexico, 06760
        • Centro Medico Dalinde
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Filios Alta Medicina
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital, Cancer and Blood Research
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologii
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gliwice, Poland, 44-102
        • Narodowy Instytut Onkologii Odzia? w Gliwicach
      • Krakow, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologii
      • Warsaw, Poland, 02-781
        • Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria
      • Lisbon, Portugal, 1350-352
        • Hospital Cuf Tejo
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Ângelo
      • Porto, Portugal, 4200-072
        • IPO do Porto
  • Romania
      • Bucharest, Romania, 021164
        • Filantropia Clinical Hospital
      • Cluj County, Romania, 407280
        • Amethyst Cluj
      • Cluj-Napoca, Romania, 400006
        • Cluj-Napoca Emergency Clinical County Hospital
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
      • Craiova, Romania, 200347
        • Centrul de Oncologie Sfantul Nectarie
      • Timișoara, Romania, 300239
        • Oncomed SRL
  • Russia
      • Kaluga, Russia, 248007
        • SBIH Kaluga Region Clinical Oncology Dispensary
      • Novosibirsk, Russia, 630099
        • LLC Medical and Sanitary Unit "Clinician"
      • Tomsk, Russia, 634063
        • Regional Oncology Dispensary
      • Yaroslavl, Russia, 150040
        • Regional Clinical Oncology Hospital
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 115478
        • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
      • Moscow, Moscow Oblast, Russia, 143422
        • MEDSI Clinical Hospital on Pyatnitsky Highway
      • Moskva, Moscow Oblast, Russia, 111123
        • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
    • Niznij Novgorod
      • Nizhny Novgorod, Niznij Novgorod, Russia, 603126
        • Nizhny Novgorod Regional Clinical Oncology Center
    • Republic of Karelia
      • Kazan, Republic of Karelia, Russia, 420029
        • Republican Clinical Oncological Dispensary of the Ministry of Healthcare
    • Sankt-Peterburg
      • Saint Peterburg, Sankt-Peterburg, Russia, 191104
        • SBI of Healthcare Leningrad Regional Oncology Dispensary
      • Saint Petersburg, Sankt-Peterburg, Russia, 196006
        • Medical Clinic "AB Medical group"
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  • Singapore
      • Singapore, Singapore, 168583
        • National Cancer Centre
  • South Korea
      • Daegu, South Korea, 41404
        • Kyungpook National University Medical Center
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Seongnam-si, South Korea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 06591
        • Seoul St Mary's Hospital
      • Seoul, South Korea, (0)6351
        • Samsung Medical Center
  • Spain
      • Granada, Spain, 18016
        • Hospital Universitario Clínico San Cecilio
      • Huelva, Spain, 21005
        • Hospital Juan Ramon Jimenez
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28223
        • Hospital Quiron de Madrid
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Hospital de Jerez de la Frontera
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Alvaro Cunqueiro
    • Tenerife
      • San Cristóbal de La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung Uni Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 00112
        • Taipei Veterans General Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Adana Baskent University Hospital
      • Ankara, Turkey (Türkiye), 06490
        • Ankara Bilkent City Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi
      • Ankara, Turkey (Türkiye), 06500
        • Gazi University Medical Faculty, Oncology Hospital
      • Antalya, Turkey (Türkiye), 07100
        • Antalya Training and Research Hospital
      • Bornova, ?zm?r, Turkey (Türkiye), 35100
        • Ege University Medical Faculty
      • Diyarbakır, Turkey (Türkiye), 21280
        • Dicle University Faculty of Medicine
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul Faculty of Medicine
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul University Cerrahpasa Faculty of Medicine
      • Istanbul, Turkey (Türkiye), 34730
        • Medeniyet University Goztepe Training and Research Hospital.
      • Izmir, Turkey (Türkiye), 35360
        • Katip Celebi University Ataturk Training and Research Hospital
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Medical Faculty of Medicine
      • Seyhan, Turkey (Türkiye), 01140
        • Medical Park Seyhan Hospital
      • Üsküdar, Turkey (Türkiye), 34662
        • Ac?badem Altunizade Hastanesi
  • Uganda
      • Kampala, Uganda, 00256
        • Uganda Cancer Institute
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
      • Kirovograd, Ukraine, 25011
        • Municipal Institution Kirovograd Regional Oncology Dispensary
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncological Center
    • Katerynoslav Governorate
      • Uzhhorod, Katerynoslav Governorate, Ukraine, 88000
        • Uzhgorod Central City Clinical Hospital
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61070
        • Municipal Noncommercial Institution Regional Center of Oncology
    • Kholm Governorate
      • Sumy, Kholm Governorate, Ukraine, 40005
        • Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Cheltenham, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - London
      • London, United Kingdom, NW1 - 2PG
        • University College London Hospital
      • London, United Kingdom, NW3 2QS
        • Royal Free Hospital
      • London, United Kingdom, EC1A 7BE
        • Barts & London School of Med
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital Nhs Trust
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Oncology
    • California
      • Buena, California, United States, 91505
        • Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
      • Santa Monica, California, United States, 90404
        • UCLA Medical Center
      • Whittier, California, United States, 90603
        • Innovation Clinical Research Institute
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Georgia
      • Carrollton, Georgia, United States, 30117
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242-1086
        • University of Iowa
    • Maine
      • Westbrook, Maine, United States, 04092
        • New England Cancer Specialists
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic
      • Knoxville, Tennessee, United States, 37916-2305
        • Thompson Cancer Survival Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg, Inc.
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates - New Port News
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23229
        • Virginia Cancer Institute
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates - Virginia Beach
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Kennewick, Washington, United States, 99336-7774
        • Kadlec Clinic Hematology and Oncology
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: Placebo + Trastuzumab Emtansine
Participants 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.
Drug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Other Names:
  • Kadcyla, T-DM1, RO5304020
Drug: Placebo
Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
Drug: Trastuzumab
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.
Other Names:
  • Herceptin
Experimental: Arm B: Atezolizumab + Trastuzumab Emtansine
Participants 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.
Drug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Other Names:
  • Kadcyla, T-DM1, RO5304020
Drug: Trastuzumab
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.
Other Names:
  • Herceptin
Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
Other Names:
  • Tecentriq, RO5541267, MPDL3280A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function
Time Frame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
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)
From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30
Time Frame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
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.
From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30
Time Frame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
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.
From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
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)
Time Frame: From baseline up to 10 years
From baseline up to 10 years
IDFS Including Second Primary Non-breast Invasive Cancer
Time Frame: From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from last participant in [LPI])
From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from last participant in [LPI])
IDFS in the PD-L1-positive and the PD-L1-negative Population
Time Frame: From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from LPI)
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).
From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from LPI)
Disease-free Survival (DFS)
Time Frame: From baseline until the first occurrence of DFS event or death, through the end of study (approximately 10 years from LPI)
From baseline until the first occurrence of DFS event or death, through the end of study (approximately 10 years from LPI)
Overall Survival (OS)
Time Frame: From baseline to death from any cause through the end of study (approximately 10 years from LPI)
From baseline to death from any cause through the end of study (approximately 10 years from LPI)
Distant Recurrence-free Interval (DRFI)
Time Frame: From baseline until distant disease recurrence, through the end of study (approximately 10 years from LPI)
From baseline until distant disease recurrence, through the end of study (approximately 10 years from LPI)
Maximum Serum Concentrations (Cmax) for Atezolizumab
Time Frame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Minimum Serum Concentrations (Cmin) for Atezolizumab
Time Frame: 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)
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)
Cmax for Trastuzumab Emtansine
Time Frame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Cmin for Trastuzumab Emtansine
Time Frame: 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)
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)
Cmax for Total Trastuzumab
Time Frame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Cmin for Total Trastuzumab
Time Frame: 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)
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)
Cmax for DM1
Time Frame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
DM1 = a thiol-containing maytansinoid anti-microtubule agent; N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine
Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab
Time Frame: 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)
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)
Percentage of Participants with ADAs to Trastuzumab Emtansine
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

October 2, 2034

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO42633
  • 2020-003681-40 (EudraCT Number)
  • 2023-503568-18-00 (Ctis: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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