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)

April 17, 2024 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.

Study Overview

Status

Recruiting

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1700

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 Contact

Name: Reference Study ID Number: WO42633 https://forpatients.roche.com/
Phone Number: 888-662-6728 (U.S. and Canada)
Email: global-roche-genentech-trials@gene.com

Study Locations

Australia
- New South Wales
  - Campbelltown, New South Wales, Australia, 2560
    - Recruiting
    - Macarthur Cancer Therapy Centre
  - Darlinghurst, New South Wales, Australia, 2010
    - Recruiting
    - Kinghorn Cancer Centre; St Vincents Hospital
  - St Leonards, New South Wales, Australia, 2065
    - Recruiting
    - Royal North Shore Hospital; Department of Medical Oncology
- Queensland
  - Woolloongabba, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital; Cancer Trials Unit
- Victoria
  - Melbourne, Victoria, Australia, 3000
    - Withdrawn
    - Peter MacCallum Cancer Centre; Medical Oncology
Austria
- - Innsbruck, Austria, 6020
    - Recruiting
    - Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  - Linz, Austria, 4010
    - Recruiting
    - Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
  - Salzburg, Austria, 5020
    - Recruiting
    - Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  - Vienna, Austria, 1090
    - Recruiting
    - AKH - Medizinische Universität Wien; Department of Oncology
Belgium
- - Bruxelles, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires St-Luc
  - Hasselt, Belgium, 3500
    - Recruiting
    - Jessa Zkh (Campus Virga Jesse)
  - Namur, Belgium, 5000
    - Recruiting
    - Clinique St. Elizabeth
Brazil
- BA
  - Salvador, BA, Brazil, 41253-190
    - Recruiting
    - Hospital Sao Rafael - HSR
- CE
  - Fortaleza, CE, Brazil, 60336-232
    - Recruiting
    - Crio - Centro Regional Integrado de Oncologia
- GO
  - Goiania, GO, Brazil, 74605-070
    - Recruiting
    - Hospital Araujo Jorge; Departamento de Ginecologia E Mama
- RS
  - Ijui, RS, Brazil, 98700-000
    - Recruiting
    - Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
  - Porto Alegre, RS, Brazil, 90610-000
    - Recruiting
    - Hospital Sao Lucas - PUCRS
  - Porto Alegre, RS, Brazil, 90020-090
    - Recruiting
    - Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, RS, Brazil, 90040-373
    - Recruiting
    - Hospital Nossa Senhora da Conceicao
- SP
  - Sao Jose do Rio Preto, SP, Brazil, 15090-000
    - Recruiting
    - Hospital de Base de Sao Jose do Rio Preto
  - Sao Paulo, SP, Brazil, 01317-001
    - Recruiting
    - Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  - Sao Paulo, SP, Brazil, 04014-002
    - Recruiting
    - Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
Bulgaria
- - Plovdiv, Bulgaria, 4004
    - Recruiting
    - COC Plovdiv; First Medical Oncology Department
  - Sofia, Bulgaria, 1330
    - Recruiting
    - Medical Center "Nadezhda Clinical" EOOD; Medical Oncology Department
  - Sofia, Bulgaria, 1527
    - Recruiting
    - University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
China
- - Chengdu City, China, 610041
    - Recruiting
    - Sichuan Cancer Hospital
  - Chengdu City, China, 610047
    - Active, not recruiting
    - West China Hospital - Sichuan University
  - Chongqing, China, 400030
    - Active, not recruiting
    - Chongqing Cancer Hospital
  - Guangzhou, China, 510000
    - Active, not recruiting
    - Sun Yat-sen Memorial Hospital
  - Guangzhou City, China, 510080
    - Active, not recruiting
    - The First Affilicated Hospital, Sun Yat-sen University
  - Guangzhou City, China, 510180
    - Active, not recruiting
    - Guangdong Provincial People's Hospital; Breast
  - Harbin, China, 150081
    - Recruiting
    - Harbin Medical University Cancer Hospital
  - Qingdao, China, 266003
    - Withdrawn
    - The Affiliated Hospital of Medical College Qingdao University
  - Shanghai, China, 200032
    - Recruiting
    - Zhongshan Hospital Fudan University
  - Tianjin, China, 3000060
    - Active, not recruiting
    - Tianjin Medical University Cancer Institute & Hospital
  - Wuhan City, China, 430023
    - Recruiting
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology
  - Xi'an, China, 710061
    - Active, not recruiting
    - First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  - Zhejiang, China, 310022
    - Recruiting
    - Zhejiang Cancer Hospital
  - Zhengzhou, China, 450008
    - Recruiting
    - Henan cancer hospital
Czechia
- - Brno, Czechia, 656 53
    - Recruiting
    - Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
  - Hradec Kralove, Czechia, 500 05
    - Recruiting
    - Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  - Novy Jicin, Czechia, 741 01
    - Recruiting
    - Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie
  - Olomouc, Czechia, 779 00
    - Recruiting
    - Fakultni nemocnice Olomouc; Onkologicka klinika
  - Praha 2, Czechia, 128 08
    - Recruiting
    - Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  - Praha 4 - Krc, Czechia, 140 59
    - Recruiting
    - Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN
  - Praha 5, Czechia, 150 06
    - Withdrawn
    - Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
Denmark
- - Herlev, Denmark, 2730
    - Recruiting
    - Herlev Hospital; Afdeling for Kræftbehandling
  - Vejle, Denmark, 7100
    - Recruiting
    - Vejle Sygehus; Onkologisk Afdeling
France
- - Avignon, France, 84082
    - Recruiting
    - Institut Sainte Catherine
  - Besançon, France, 25030
    - Recruiting
    - CHRU Besançon
  - Bordeaux, France, 33300
    - Recruiting
    - Polyclinique Bordeaux Nord Aquitaine
  - Brest, France, 29200
    - Recruiting
    - Hopital Morvan
  - Caen, France, 14076
    - Active, not recruiting
    - Centre Francois Baclesse; Comite Sein
  - Creil Cedex 1, France, 60109
    - Recruiting
    - Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie
  - Lyon, France, 69008
    - Recruiting
    - CLCC Leon Berard Lyon
  - Nimes, France, 30029
    - Recruiting
    - Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
  - Paris, France, 75020
    - Recruiting
    - Groupe Hospitalier Diaconesses
  - Paris, France, 75231
    - Recruiting
    - Institut Curie; Oncologie Medicale
  - Poitiers, France, 86021
    - Recruiting
    - Pole Regional De Cancerologie
  - Saint-Cloud, France, 92210
    - Active, not recruiting
    - HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale.
Germany
- - Augsburg, Germany, 86156
    - Recruiting
    - Klinikum Augsburg; Frauenklinik
  - Aurich, Germany, 26603
    - Recruiting
    - Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen
  - Bad Homburg vdH, Germany, 61352
    - Withdrawn
    - Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik
  - Bad Nauheim, Germany, 61231
    - Recruiting
    - Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
  - Berlin, Germany, 10707
    - Recruiting
    - Onkologische Schwerpunktpraxis Kurfürstendamm
  - Berlin, Germany, 10967
    - Withdrawn
    - Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen
  - Bonn, Germany, 53111
    - Recruiting
    - Gynäkologisches Zentrum Bonn
  - Bottrop, Germany, 46236
    - Recruiting
    - Marienhospital Bottrop
  - Dessau-Roßlau, Germany, 06847
    - Recruiting
    - Städtisches Klinikum Dessau
  - Düsseldorf, Germany, 40235
    - Recruiting
    - Gynonco Düsseldorf, MVZ Medical Center GmbH
  - Erfurt, Germany, 99084
    - Active, not recruiting
    - Frauenarztpraxis Dr. Apel, Dr. Kolpin
  - Erlangen, Germany, 91054
    - Completed
    - Universitätsklinikum Erlangen; Frauenklinik
  - Essen, Germany, 45136
    - Recruiting
    - Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  - Frankfurt, Germany, 60431
    - Recruiting
    - AGAPLESION Markus-Krankenhaus
  - Frankfurt, Germany, 60596
    - Recruiting
    - Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
  - Freiburg, Germany, 79110
    - Recruiting
    - Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  - Hamm, Germany, 59073
    - Withdrawn
    - St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik
  - Hannover, Germany, 30559
    - Recruiting
    - Diakovere Henriettenstift, Frauenklinik
  - Karlsruhe, Germany, 76133
    - Recruiting
    - Städtisches Klinikum Karlsruhe gGmbH; Frauenklinik
  - Kiel, Germany, 24105
    - Recruiting
    - UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
  - Leipzig, Germany, 04103
    - Recruiting
    - Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde
  - Lüneburg, Germany, 21339
    - Recruiting
    - Städtische Klinik Lüneburg; Frauenklinik
  - München, Germany, 80336
    - Active, not recruiting
    - Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
  - Offenbach, Germany, 63069
    - Withdrawn
    - Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  - Potsdam, Germany, 14467
    - Recruiting
    - Klinikum Ernst von Bergmann; Frauenklinik
  - Reutlingen, Germany, 72764
    - Withdrawn
    - Klinikum am Steinenberg Frauenklinik
  - Schweinfurt, Germany, 97422
    - Recruiting
    - Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
  - Stendal, Germany, 39576
    - Recruiting
    - Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe
Greece
- - Athens, Greece, 115 22
    - Recruiting
    - Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
  - Athens, Greece, 115 28
    - Recruiting
    - Alexandras General Hospital of Athens; Oncology Department
  - Cholargos, Greece, 155 62
    - Recruiting
    - Metropolitan General Hospital
  - Crete, Greece, 711 10
    - Recruiting
    - University General Hospital of Heraklion
  - Larissa, Greece, 411 10
    - Recruiting
    - University Hospital of Larissa;Department of Medical Oncology
  - Piraeus, Greece, 185 47
    - Recruiting
    - Metropolitan Hospital; 2Nd Oncology Clinic
  - Thessaloniki, Greece, 546 45
    - Recruiting
    - Euromedical General Clinic of Thessaloniki; Oncology Department
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
  - Hong Kong, Hong Kong
    - Recruiting
    - Tuen Mun Hospital; Clinical Oncology
  - Hong Kong, Hong Kong, 852
    - Active, not recruiting
    - Queen Mary Hospital; Surgery
Hungary
- - Budapest, Hungary, 1122
    - Recruiting
    - Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  - Budapest, Hungary, 1062
    - Recruiting
    - Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephely
  - Budapest, Hungary, 1032
    - Recruiting
    - Budapesti Szent Margit Korhaz; Onkologia Osztaly
  - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
  - Miskolc, Hungary, 3501
    - Recruiting
    - Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
India
- Delhi
  - New Delhi, Delhi, India, 110085
    - Active, not recruiting
    - Rajiv Gandhi Cancer Institute & Research Center
  - North WEST Delhi, Delhi, India, 110088
    - Recruiting
    - Max Super Speciality Hospital; Medical Oncology
- Gujarat
  - Ahmadabad, Gujarat, India, 380054
    - Active, not recruiting
    - Hemato Oncology Clinic Ahmedabad Pvt Ltd
- Karnataka
  - Bangalore, Karnataka, India, 560017
    - Recruiting
    - Manipal Hospital; Department of Oncology
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Recruiting
    - Tata Memorial Hospital; Dept of Medical Oncology
  - Nashik, Maharashtra, India, 422002
    - Active, not recruiting
    - HCG Manavata Cancer Centre
  - Pune, Maharashtra, India, 411028
    - Recruiting
    - Sahyadri Super Specialty Hospital Hadapsar
- Tamil NADU
  - Ratnagiri Kilminnal, Tamil NADU, India, 632517
    - Active, not recruiting
    - Christian Med Clg & Hspt
- WEST Bengal
  - Kolkata, WEST Bengal, India, 700156
    - Active, not recruiting
    - TATA Medical Centre; Medical Oncology
Italy
- Campania
  - Avellino, Campania, Italy, 83100
    - Recruiting
    - AORN'S.G.Moscati; Oncologia
  - Napoli, Campania, Italy, 80131
    - Recruiting
    - U.O.C. Oncologia Medica Senologica
  - Napoli, Campania, Italy, 80131
    - Recruiting
    - Università degli Studi Federico II; Clinica di Oncologia Medica
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - Withdrawn
    - Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
  - Modena, Emilia-Romagna, Italy, 41124
    - Recruiting
    - A.O. Universitaria Policlinico Di Modena; Oncologia
- Friuli-Venezia Giulia
  - Aviano, Friuli-Venezia Giulia, Italy, 33081
    - Recruiting
    - Irccs Centro Di Riferimento Oncologico (CRO)
  - Udine, Friuli-Venezia Giulia, Italy, 33100
    - Withdrawn
    - ASU FC S. M. DELLA MISERICORDIA; Oncologia
- Lazio
  - Roma, Lazio, Italy, 00168
    - Recruiting
    - Policlinico Universitario Agostino Gemelli
- Lombardia
  - Brescia, Lombardia, Italy, 25123
    - Recruiting
    - ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
  - Milano, Lombardia, Italy, 20133
    - Recruiting
    - Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  - Milano, Lombardia, Italy, 20132
    - Recruiting
    - Ospedale San Raffaele; Medical Oncology
- Toscana
  - Livorno, Toscana, Italy, 57124
    - Recruiting
    - Ospedale Civile - Livorno
  - Pisa, Toscana, Italy, 56100
    - Recruiting
    - Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
- Umbria
  - Novara, Umbria, Italy, 28100
    - Recruiting
    - University of Eastern Piedmont - Maggiore della Carità University Hospital
- Veneto
  - Padova, Veneto, Italy, 35128
    - Withdrawn
    - IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Kenya
- - Eldoret, Kenya, 30100
    - Recruiting
    - International Cancer Institute (ICI)
  - Nairobi, Kenya, 00100
    - Recruiting
    - Aga Khan University Hospital
Korea, Republic of
- - Daegu, Korea, Republic of, 41404
    - Recruiting
    - Kyungpook National University Medical Center
  - Goyang-si, Korea, Republic of, 10408
    - Recruiting
    - National Cancer Center
  - Seongnam-si, Korea, Republic of, 463-707
    - Recruiting
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 08308
    - Recruiting
    - Korea University Guro Hospital
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Active, not recruiting
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06351
    - Active, not recruiting
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 06273
    - Recruiting
    - Gangnam Severance Hospital
  - Seoul, Korea, Republic of, 06591
    - Recruiting
    - Seoul St Mary's Hospital
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 02841
    - Recruiting
    - Korea University Anam Hospital
Mexico
- BAJA California SUR
  - La Paz, BAJA California SUR, Mexico, 23040
    - Recruiting
    - Investigacion Oncofarmaceutica
- Mexico CITY (federal District)
  - Cdmx, Mexico CITY (federal District), Mexico, 03100
    - Recruiting
    - Health Pharma Professional Research
  - Cdmx, Mexico CITY (federal District), Mexico, 06760
    - Active, not recruiting
    - Centro Medico Dalinde
  - Distrito Federal, Mexico CITY (federal District), Mexico, 14000
    - Recruiting
    - Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
- Nuevo LEON
  - Monterrey, Nuevo LEON, Mexico, 64460
    - Recruiting
    - Filios Alta Medicina
- Oaxaca
  - Oaxaca de Juárez, Oaxaca, Mexico, 68020
    - Recruiting
    - Centro de Investigacion Clinica de Oaxaca
New Zealand
- - Auckland, New Zealand, 1023
    - Recruiting
    - Auckland City Hospital, Cancer and Blood Research
  - Tauranga, New Zealand, 3112
    - Recruiting
    - Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Poland
- - Bialystok, Poland, 15-027
    - Active, not recruiting
    - Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  - Gdansk, Poland, 80-214
    - Recruiting
    - Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  - Gliwice, Poland, 44-102
    - Recruiting
    - Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
  - Kraków, Poland, 30-688
    - Recruiting
    - Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  - Poznan, Poland, 61-866
    - Active, not recruiting
    - Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
  - Warszawa, Poland, 02-781
    - Active, not recruiting
    - Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk
Portugal
- - Lisboa, Portugal, 1649-035
    - Recruiting
    - Hospital de Santa Maria; Servico de Oncologia Medica
  - Lisboa, Portugal, 1350-352
    - Recruiting
    - Hospital CUF Tejo; Oncologia Médica e Hematologia
  - Loures, Portugal, 2674-514
    - Recruiting
    - Hospital Beatriz Angelo; Departamento de Oncologia
  - Porto, Portugal, 4200-072
    - Recruiting
    - IPO do Porto; Servico de Oncologia Medica
  - Porto, Portugal, 4099-001
    - Withdrawn
    - Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
Romania
- - Bucuresti, Romania, 021164
    - Active, not recruiting
    - Filantropia Clinical Hospital; Medical oncology
  - Bucuresti, Romania, 022328
    - Withdrawn
    - Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I
  - Cluj County, Romania, 407280
    - Active, not recruiting
    - Amethyst Cluj; Medical Oncology
  - Cluj-Napoca, Romania, 400015
    - Recruiting
    - Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie
  - Cluj-Napoca, Romania, 400006
    - Active, not recruiting
    - Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology
  - Craiova, Romania, 200347
    - Active, not recruiting
    - Centrul de Oncologie Sfantul Nectarie
  - Timisoara, Romania, 300239
    - Recruiting
    - Oncomed Srl
Russian Federation
- - Kaluga, Russian Federation, 248007
    - Active, not recruiting
    - SBIH Kaluga Region Clinical Oncology Dispensary
  - Novosibirsk, Russian Federation, 630099
    - Active, not recruiting
    - LLC Medical and Sanitary Unit "Clinician"
  - Samara, Russian Federation, 443031
    - Withdrawn
    - SBI of Healthcare Samara Regional Clinical Oncology Dispensary
  - Tomsk, Russian Federation, 634063
    - Active, not recruiting
    - Regional Oncology Dispensary
  - Yaroslavl, Russian Federation, 150040
    - Active, not recruiting
    - Regional Clinical Oncology Hospital
- Karelija
  - Kazan, Karelija, Russian Federation, 420029
    - Active, not recruiting
    - Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department
- Krasnodar
  - Krasnoyarsk, Krasnodar, Russian Federation, 660133
    - Completed
    - Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
- Moskovskaja Oblast
  - Moscow, Moskovskaja Oblast, Russian Federation, 143422
    - Active, not recruiting
    - MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
  - Moscow, Moskovskaja Oblast, Russian Federation, 105005
    - Withdrawn
    - Oncology Dispensary#1; Out-Patient Oncology Dept
  - Moscow, Moskovskaja Oblast, Russian Federation, 115478
    - Active, not recruiting
    - FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
  - Moskva, Moskovskaja Oblast, Russian Federation, 111123
    - Active, not recruiting
    - SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
- Niznij Novgorod
  - Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603126
    - Active, not recruiting
    - Nizhny Novgorod Regional Clinical Oncology Center
- Sankt Petersburg
  - Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758
    - Active, not recruiting
    - S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  - Sankt-peterburg, Sankt Petersburg, Russian Federation, 196006
    - Active, not recruiting
    - Medical Clinic "AB Medical group"
  - St PETERBURG, Sankt Petersburg, Russian Federation, 191104
    - Active, not recruiting
    - SBI of Healthcare Leningrad Regional Oncology Dispensary
  - St Petersburg, Sankt Petersburg, Russian Federation, 197758
    - Active, not recruiting
    - FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
Singapore
- - Singapore, Singapore, 168583
    - Recruiting
    - National Cancer Centre; Medical Oncology
Spain
- - Barcelona, Spain, 08003
    - Recruiting
    - Hospital del Mar; Servicio de Oncologia
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic Barcelona; Servicio de oncologia
  - Barcelona, Spain, 08035
    - Recruiting
    - Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  - Granada, Spain, 18016
    - Active, not recruiting
    - Hospital Universitario Clínico San Cecilio; Servicio de oncologia
  - Huelva, Spain, 21005
    - Recruiting
    - Hospital Juan Ramon Jimenez;Servicio de Oncologia
  - Jaen, Spain, 23007
    - Recruiting
    - Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  - Madrid, Spain, 28040
    - Active, not recruiting
    - Hospital Clinico San Carlos; Servicio de Oncologia
  - Madrid, Spain, 28046
    - Withdrawn
    - Hospital Universitario La Paz; Servicio de Oncologia
  - Madrid, Spain, 28034
    - Withdrawn
    - Hospital Ramon y Cajal; Servicio de Oncologia
  - Malaga, Spain, 29010
    - Recruiting
    - Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  - Salamanca, Spain, 37007
    - Recruiting
    - Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
  - Sevilla, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena; Servicio de Oncologia
  - Sevilla, Spain, 41013
    - Active, not recruiting
    - Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clínico Universitario de Valencia; Servicio de Oncología
  - Valencia, Spain, 46017
    - Recruiting
    - Hospital Universitario Dr. Peset; Servicio de Oncologia
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet; Servicio Oncologia
- Alicante
  - Elche, Alicante, Spain, 03203
    - Recruiting
    - Hospital General Universitario de Elche; Servicio de Oncologia
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Recruiting
    - Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  - Sabadell, Barcelona, Spain, 8208
    - Recruiting
    - Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
- Cadiz
  - Jerez de La Frontera, Cadiz, Spain, 11407
    - Recruiting
    - Hospital de Jerez de la Frontera; Servicio de Oncologia
- LA Coruña
  - A Coruña, LA Coruña, Spain, 15006
    - Recruiting
    - Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  - Santiago de Compostela, LA Coruña, Spain, 15706
    - Recruiting
    - Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
- Madrid
  - Pozuelo de Alarcon, Madrid, Spain, 28223
    - Recruiting
    - Hospital Quiron de Madrid; Servicio de Oncologia
- Pontevedra
  - Vigo, Pontevedra, Spain, 36213
    - Recruiting
    - Hospital Alvaro Cunqueiro; Servicio de Oncologia
- Tenerife
  - La Laguna, Tenerife, Spain, 38320
    - Recruiting
    - Hospital Universitario de Canarias;servicio de Oncologia
- Vizcaya
  - Bilbao, Vizcaya, Spain, 48013
    - Recruiting
    - Hospital de Basurto; Servicio de Oncologia
Taiwan
- - Chia-Yi, Taiwan, 600
    - Recruiting
    - Chia-Yi Christian Hospital; Division of Hemato-oncology
  - Taichung, Taiwan, 404
    - Recruiting
    - China Medical University Hospital; Surgery
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
  - Taipei, Taiwan, 104
    - Recruiting
    - Mackay Memorial Hospital; Dept of Surgery
  - Taipei, Taiwan, 00112
    - Recruiting
    - Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy
  - Taipei 100, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  - Bangkok, Thailand, 10330
    - Active, not recruiting
    - Chulalongkorn Hospital; Medical Oncology
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Srinagarind Hospital; Department of Surgery
  - Songkla, Thailand, 90110
    - Recruiting
    - Songklanagarind Hospital; Department of Surgery
Turkey
- - Adana, Turkey, 01120
    - Recruiting
    - Adana Baskent University Hospital; Medical Oncology
  - Ankara, Turkey, 06520
    - Recruiting
    - Memorial Ankara Hastanesi
  - Ankara, Turkey, 06500
    - Recruiting
    - Gazi University Medical Faculty, Oncology Hospital
  - Ankara, Turkey, 06100
    - Active, not recruiting
    - Hacettepe University Medical Faculty
  - Ankara, Turkey, 06490
    - Recruiting
    - Ankara Bilkent City Hospital
  - Antalya, Turkey, 07100
    - Active, not recruiting
    - Antalya Training and Research Hospital ; Oncology Department
  - Bornova, ?zm?r, Turkey, 35100
    - Recruiting
    - Ege University Medical Faculty; Medical Oncology Department
  - Diyarbakir, Turkey, 21280
    - Recruiting
    - Dicle University Faculty of Medicine
  - Edirne, Turkey, 22030
    - Active, not recruiting
    - Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  - Istanbul, Turkey, 34093
    - Active, not recruiting
    - Istanbul Faculty of Medicine
  - Istanbul, Turkey, 34098
    - Active, not recruiting
    - Istanbul University Cerrahpasa Faculty of Medicine
  - Izmir, Turkey, 35360
    - Active, not recruiting
    - Katip Celebi University Ataturk Training and Research Hospital; Oncology
  - Kadiköy, Turkey, 34722
    - Recruiting
    - Medeniyet University Goztepe Training and Research Hospital.
  - Malatya, Turkey, 44280
    - Active, not recruiting
    - Inonu University Medical Faculty of Medicine; Medical Oncology Department
  - Seyhan, Turkey, 01140
    - Recruiting
    - Medical Park Seyhan Hospital; Oncology Department
  - Üsküdar, Turkey, 34662
    - Recruiting
    - Ac?badem Altunizade Hastanesi; Oncology
Uganda
- - Kampala, Uganda
    - Active, not recruiting
    - Uganda Cancer Institute
Ukraine
- - Dnipropetrovsk, Ukraine, 49102
    - Recruiting
    - CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
  - Kirovograd, Ukraine, 25011
    - Recruiting
    - Municipal Institution Kirovograd Regional Oncology Dispensary
  - Kyiv, Ukraine, 03115
    - Recruiting
    - Kyiv City Clinical Oncological Center
- KIEV Governorate
  - Dnipro, KIEV Governorate, Ukraine, 49100
    - Withdrawn
    - MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department
  - Liutizh, KIEV Governorate, Ukraine, 07352
    - Recruiting
    - Innovacia Cancer Center
- Katerynoslav Governorate
  - Uzhhorod, Katerynoslav Governorate, Ukraine, 88000
    - Active, not recruiting
    - Uzhgorod Central City Clinical Hospital
- Kharkiv Governorate
  - Kharkiv, Kharkiv Governorate, Ukraine, 61070
    - Recruiting
    - Municipal Noncommercial Institution Regional Center of Oncology
- Kholm Governorate
  - Sumy, Kholm Governorate, Ukraine, 40005
    - Recruiting
    - Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
United Kingdom
- - Belfast, United Kingdom, BT9 7AB
    - Withdrawn
    - Belfast City Hospital
  - Blackpool, United Kingdom, FY3 8NR
    - Recruiting
    - Blackpool Victoria Hospital
  - Bradford, United Kingdom, BD9 6RJ
    - Recruiting
    - Bradford Royal Infirmary; Oncology Department
  - Brighton, United Kingdom, BN2 5BE
    - Active, not recruiting
    - Royal Sussex County Hospital
  - Cambridge, United Kingdom, CB2 0QQ
    - Active, not recruiting
    - Addenbrookes Hospital
  - Cardiff, United Kingdom, CF14 2TL
    - Active, not recruiting
    - Velindre Cancer Centre; Clinical Trials Unit
  - Cheltenham, United Kingdom, GL53 7AN
    - Recruiting
    - Cheltenham General Hospital
  - Cornwall, United Kingdom, TR1 3LQ
    - Active, not recruiting
    - Royal Cornwall Hospital; Dept of Clinical Oncology
  - East Kilbride, United Kingdom, G75 8RG
    - Active, not recruiting
    - Hairmyres Hospital
  - Inverness, United Kingdom, IV2 3UV
    - Active, not recruiting
    - Raigmore Hospital
  - London, United Kingdom, NW3 2QS
    - Recruiting
    - Royal Free Hospital
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - Royal Marsden Hospital - London
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Barts & London School of Med; Medical Oncology
  - London, United Kingdom, N7 9NH
    - Recruiting
    - University College London Hospital
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Christie Hospital NHS Trust
  - Northwood, United Kingdom, HA6 2RN
    - Active, not recruiting
    - Mount Vernon Cancer Centre
  - Nottingham, United Kingdom, NG5 1PB
    - Completed
    - Nottingham City Hospital
  - Preston, United Kingdom, PR2 9HT
    - Active, not recruiting
    - Royal Preston Hospital
  - Rhyl, United Kingdom, LL18 5UJ
    - Withdrawn
    - Glan Clywd Hospital
  - Somerset, United Kingdom, TA1 5DA
    - Recruiting
    - Musgrove Park Hospital
  - Surrey, United Kingdom, SM2 5PT
    - Recruiting
    - Royal Marsden Hospital - Surrey
  - Walsall, United Kingdom, WS2 9PS
    - Active, not recruiting
    - Walsall Manor Hospital
United States
- Alabama
  - Alabaster, Alabama, United States, 35007
    - Recruiting
    - Alabama Oncology
- California
  - Burbank, California, United States, 91505
    - Recruiting
    - Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
  - Cerritos, California, United States, 90703
    - Active, not recruiting
    - Innovation Clinical Research Institute
  - Fresno, California, United States, 93720
    - Recruiting
    - California Cancer Associate for Research & Excellence
  - Glendale, California, United States, 91206
    - Withdrawn
    - Glendale Adventist Medical Ctr
  - Santa Monica, California, United States, 90404
    - Active, not recruiting
    - UCLA Medical Center
- Florida
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Florida Cancer Specialists
- Georgia
  - Athens, Georgia, United States, 30607
    - Recruiting
    - University Cancer & Blood Center, LLC; Research
  - Carrollton, Georgia, United States, 30117
    - Active, not recruiting
    - Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
- Illinois
  - Elmhurst, Illinois, United States, 60126
    - Withdrawn
    - Elmhurst Memorial Healthcare
  - Naperville, Illinois, United States, 60540
    - Withdrawn
    - Edward Cancer Center Naperville
  - Plainfield, Illinois, United States, 60585
    - Withdrawn
    - Edward Cancer Center Plainfield
- Iowa
  - Iowa City, Iowa, United States, 52242-1086
    - Recruiting
    - University of Iowa
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Withdrawn
    - Pontchartrain Cancer Center
- Maine
  - Scarborough, Maine, United States, 04074
    - Recruiting
    - New England Cancer Specialists
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Recruiting
    - Mercy Medical Center
  - Baltimore, Maryland, United States, 21201
    - Active, not recruiting
    - University of Maryland Medical Center
  - Baltimore, Maryland, United States, 21204
    - Recruiting
    - Greater Baltimore Med Ctr; Dept Berman Cancer Institute
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Health System; Clinical Trials Office; Clinical Trials Office
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Recruiting
    - Jackson Oncology Associates, PLLC
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Withdrawn
    - Central Care Cancer Center; NC
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Withdrawn
    - MD Anderson Cancer Center at Cooper
  - Neptune, New Jersey, United States, 07753
    - Withdrawn
    - Jersey Shore University Medical Centre
  - Paramus, New Jersey, United States, 07652
    - Recruiting
    - The Valley Hospital
- New York
  - New York, New York, United States, 10029
    - Active, not recruiting
    - Mount Sinai Medical Center
  - Williamsville, New York, United States, 14221
    - Withdrawn
    - Great Lakes Cancer Center
- North Carolina
  - Asheville, North Carolina, United States, 28806
    - Withdrawn
    - Messino Cancer Centers
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Levine Cancer Institute
- Oregon
  - Portland, Oregon, United States, 97213
    - Withdrawn
    - Providence Health & Services - Oregon
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010-3121
    - Recruiting
    - Bryn Mawr Hospital
  - Philadelphia, Pennsylvania, United States, 19106
    - Recruiting
    - Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
  - Wynnewood, Pennsylvania, United States, 19096
    - Recruiting
    - Lankenau Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Recruiting
    - Roper St. Francis Healthcare
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Completed
    - Avera Cancer Institute
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Withdrawn
    - Sarah Cannon Research Institute / Tennessee Oncology
  - Germantown, Tennessee, United States, 38138
    - Active, not recruiting
    - The West Clinic; West Cancer Center
  - Knoxville, Tennessee, United States, 37916-2305
    - Recruiting
    - Thompson Cancer Survival Center
  - Nashville, Tennessee, United States, 37203
    - Withdrawn
    - SCRI Oncology Partners
- Texas
  - Lubbock, Texas, United States, 79410
    - Recruiting
    - Joe Arrington Cancer Research & Treatment Center
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
- Virginia
  - Fredericksburg, Virginia, United States, 22408
    - Recruiting
    - Hematology Oncology Associates of Fredericksburg, Inc.
  - Newport News, Virginia, United States, 23606
    - Recruiting
    - Virginia Oncology Associates - New Port News
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Virginia Oncology Associates
  - Richmond, Virginia, United States, 23229
    - Active, not recruiting
    - Virginia Cancer Institute
  - Virginia Beach, Virginia, United States, 23456
    - Recruiting
    - Virginia Oncology Associates - Virginia Beach
- Washington
  - Everett, Washington, United States, 98201
    - Recruiting
    - Providence Regional Cancer Partnership
  - Kennewick, Washington, United States, 99336-7774
    - Recruiting
    - Kadlec Clinic Hematology and Oncology
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - 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

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

Number of Arms

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

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) Time Frame: From randomization up to approximately 6 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 randomization up to approximately 6 years

Secondary Outcome Measures

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

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.

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)

June 25, 2026

Study Completion (Estimated)

June 29, 2035

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)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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National Cancer Institute (NCI)

Withdrawn

T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

Anatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | HER2 Positive Breast Carcinoma | Metastatic Breast Carcinoma

United States
Jenny C. Chang, MD
Genentech, Inc.; The Methodist Hospital Research Institute

Withdrawn

Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer (NATURE)

Breast Cancer

United States
Hoffmann-La Roche
Roche Pharma AG

Completed

A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

Metastatic Breast Cancer

Italy, Spain, Canada, United States, Belgium, France, Germany
University of Washington
National Cancer Institute (NCI)

Completed

Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery

Stage IV Breast Cancer | Recurrent Breast Carcinoma | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | HER2/Neu Positive

United States
Dana-Farber Cancer Institute
Merck Sharp & Dohme LLC

Active, not recruiting

A Study Of Pembrolizumab In Combination With Trastuzumab-DM1

Breast Cancer

United States
Hoffmann-La Roche

Completed

A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Breast Cancer

United States, Canada, Spain, France, Italy
Genentech, Inc.

Completed

A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Metastatic Breast Cancer

United States
Spectrum Pharmaceuticals, Inc

Terminated

A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

Breast Cancer

United States
Consorzio Oncotech
Roche Pharma AG

Recruiting

Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy

Breast Cancer

Italy

Outcome Measure	Measure Description	Time Frame
IDFS Including Second Primary Non-breast Invasive Cancer Time Frame: From baseline up to 10 years		From baseline up to 10 years
Disease-free Survival (DFS) Time Frame: From baseline up to 10 years		From baseline up to 10 years
Overall Survival (OS) Time Frame: From baseline up to 10 years		From baseline up to 10 years
Distant Recurrence-free Interval (DRFI) Time Frame: From baseline up to 10 years		From baseline up to 10 years
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
Maximum Serum Concentrations (Cmax) for Atezolizumab Time Frame: Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 pre-infusion (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 pre-infusion (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 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (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 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (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 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)	DM1 = a thiol-containing maytansinoid anti-microtubule agent; N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine	Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Minimum Serum Concentrations (Cmin) for Atezolizumab Time Frame: Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab Time Frame: Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (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: Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

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)

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

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