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
NCT ID: NCT04873362
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1188 participants
INTERVENTIONAL
2021-05-04
2034-10-02
Brief Summary
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As of June 4, 2024, this study is no longer accepting any newly screened participants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Placebo
Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
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.
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.
Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
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.
Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
Interventions
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Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Placebo
Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
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.
Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alabama Oncology
Birmingham, Alabama, United States
Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
Buena, California, United States
UCLA Medical Center
Santa Monica, California, United States
Innovation Clinical Research Institute
Whittier, California, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
New England Cancer Specialists
Westbrook, Maine, United States
The Valley Hospital
Paramus, New Jersey, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
Philadelphia, Pennsylvania, United States
The West Clinic
Germantown, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
San Antonio, Texas, United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
Virginia Oncology Associates - New Port News
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, , Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg
Salzburg, , Austria
Cliniques Universitaires St-Luc
Brussels, , Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, , Belgium
Clinique St. Elizabeth
Namur, , Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, Brazil
COC Plovdiv
Plovdiv, , Bulgaria
Medical Center "Nadezhda Clinical" EOOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, , Bulgaria
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital - Sichuan University
Chengdu, , China
Chongqing Cancer Hospital
Chongqing, , China
Sun Yat-sen Memorial Hospital
Guangzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affilicated Hospital, Sun Yat-sen University
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Masaryk?v onkologický ústav
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice
Prague, , Czechia
Fakultni Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Vejle Sygehus
Vejle, , Denmark
Institut Sainte Catherine
Avignon, , France
CHRU Besançon
Besançon, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CHU Brest Hopital La Cavale Blanche
Brest, , France
Centre Francois Baclesse
Caen, , France
Groupe Hospitalier Public Du Sud De L'Oise GHPSO
Creil, , France
CLCC Leon Berard Lyon
Lyon, , France
Centre Hospitalier Uni Ire Caremeau
Nîmes, , France
Groupe Hospitalier Diaconesses
Paris, , France
Institut Curie
Paris, , France
Pole Regional De Cancerologie
Poitiers, , France
HOPITAL RENE HUGUENIN, Institut Curie
Saint-Cloud, , France
Klinikum Augsburg
Augsburg, , Germany
Hochwaldkrankenhaus
Bad Nauheim, , Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, , Germany
Gynäkologisches Zentrum Bonn
Bonn, , Germany
Marienhospital Bottrop
Bottrop, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH
Düsseldorf, , Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Erfurt, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, , Germany
AGAPLESION Markus-Krankenhaus
Frankfurt, , Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, , Germany
Diakovere Henriettenstift, Frauenklinik
Hanover, , Germany
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel, , Germany
Städtische Klinik Lüneburg
Lüneburg, , Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, , Germany
Klinikum Ernst von Bergmann
Potsdam, , Germany
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
Schweinfurt, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen
Westerstede, , Germany
Anticancer Hospital Ag. Savas
Athens, , Greece
Alexandras General Hospital of Athens
Athens, , Greece
University General Hospital of Heraklion
Crete, , Greece
University Hospital of Larissa
Larissa, , Greece
Metropolitan Hospital
Piraeus, , Greece
European Interbalkan Medical Center
Thessaloniki, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, , Hong Kong
Tuen Mun Hospital
Hong Kong, , Hong Kong
Budapesti Szent Margit Korhaz
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Hemato Oncology Clinic Ahmedabad Pvt Ltd
Ahmedabad, Gujarat, India
Manipal Hospital
Bangalore, Karnataka, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, India
Sahyadri Super Specialty Hospital Hadapsar
Pune, Maharashtra, India
Rajiv Gandhi Cancer Institute & Research Center
New Delhi, National Capital Territory of Delhi, India
Max Super Speciality Hospital
North WEST Delhi, National Capital Territory of Delhi, India
Christian Med Clg & Hspt
Ratnagiri Kilminnal, Tamil Nadu, India
TATA Medical Centre
Kolkata, West Bengal, India
AORN'S.G.Moscati
Avellino, Campania, Italy
U.O.C. Oncologia Medica Senologica
Napoli, Campania, Italy
Università degli Studi Federico II
Napoli, Campania, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Ospedale Civile - Livorno
Livorno, Tuscany, Italy
Azlenda Ospendaliero-Universitaria Pisana
Pisa, Tuscany, Italy
The Aga Khan University-Kenya.
Nairobi, , Kenya
Investigacion Oncofarmaceutica
La Paz, Baja California Sur, Mexico
Instituto Nacional De Cancerologia
Distrito Federal, Mexico CITY (federal District), Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Centro Medico Dalinde
Mexico City, Mexico CITY (federal District), Mexico
Filios Alta Medicina
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Auckland City Hospital, Cancer and Blood Research
Auckland, , New Zealand
Bialostockie Centrum Onkologii
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, , Poland
Wielkopolskie Centrum Onkologii
Poznan, , Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
Warsaw, , Poland
Hospital CUF Tejo
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Hospital Beatriz Angelo
Loures, , Portugal
IPO do Porto
Porto, , Portugal
Filantropia Clinical Hospital
Bucharest, , Romania
Amethyst Cluj
Cluj County, , Romania
Cluj-Napoca Emergency Clinical County Hospital
Cluj-Napoca, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, , Romania
Oncomed SRL
Timișoara, , Romania
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, Moscow Oblast, Russia
MEDSI Clinical Hospital on Pyatnitsky Highway
Moscow, Moscow Oblast, Russia
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moscow Oblast, Russia
Nizhny Novgorod Regional Clinical Oncology Center
Nizhny Novgorod, Niznij Novgorod, Russia
Republican Clinical Oncological Dispensary of the Ministry of Healthcare
Kazan, Republic of Karelia, Russia
SBI of Healthcare Leningrad Regional Oncology Dispensary
Saint Peterburg, Sankt-Peterburg, Russia
Medical Clinic "AB Medical group"
Saint Petersburg, Sankt-Peterburg, Russia
FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
Saint Petersburg, Sankt-Peterburg, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, Russia
SBIH Kaluga Region Clinical Oncology Dispensary
Kaluga, , Russia
LLC Medical and Sanitary Unit "Clinician"
Novosibirsk, , Russia
Regional Oncology Dispensary
Tomsk, , Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
National Cancer Centre
Singapore, , Singapore
Kyungpook National University Medical Center
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital de Jerez de la Frontera
Jerez de la Frontera, Cadiz, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Juan Ramon Jimenez
Huelva, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaén, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Quiron de Madrid
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Chia-Yi Christian Hospital
Chiayi City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung Uni Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty, Oncology Hospital
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Antalya Training and Research Hospital
Antalya, , Turkey (Türkiye)
Ege University Medical Faculty
Bornova, ?zm?r, , Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, , Turkey (Türkiye)
Istanbul Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Medeniyet University Goztepe Training and Research Hospital.
Istanbul, , Turkey (Türkiye)
Katip Celebi University Ataturk Training and Research Hospital
Izmir, , Turkey (Türkiye)
Inonu University Medical Faculty of Medicine
Malatya, , Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, , Turkey (Türkiye)
Ac?badem Altunizade Hastanesi
Üsküdar, , Turkey (Türkiye)
Uganda Cancer Institute
Kampala, , Uganda
Uzhgorod Central City Clinical Hospital
Uzhhorod, Katerynoslav Governorate, Ukraine
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv, Kharkiv Governorate, Ukraine
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
Sumy, Kholm Governorate, Ukraine
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, , Ukraine
Municipal Institution Kirovograd Regional Oncology Dispensary
Kirovograd, , Ukraine
Kyiv City Clinical Oncological Center
Kyiv, , Ukraine
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Cheltenham General Hospital
Cheltenham, , United Kingdom
Barts & London School of Med
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Royal Marsden Hospital - London
London, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2020-003681-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503568-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
WO42633
Identifier Type: -
Identifier Source: org_study_id
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