Clinical trial NCT04873362: 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
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 1188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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


Eligibility criteria: 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

Primary outcomes:
measure: Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS)
timeFrame: From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 years)
Secondary outcomes:
measure: IDFS Including Second Primary Non-breast Invasive Cancer
timeFrame: From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from last participant in [LPI])
measure: IDFS in the PD-L1-positive and the PD-L1-negative Population
timeFrame: From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from LPI)
measure: Disease-free Survival (DFS)
timeFrame: From baseline until the first occurrence of DFS event or death, through the end of study (approximately 10 years from LPI)
measure: Overall Survival (OS)
timeFrame: From baseline to death from any cause through the end of study (approximately 10 years from LPI)
measure: Distant Recurrence-free Interval (DRFI)
timeFrame: From baseline until distant disease recurrence, through the end of study (approximately 10 years from LPI)
measure: Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function
timeFrame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
measure: Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30
timeFrame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
measure: Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30
timeFrame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
measure: 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)
timeFrame: From baseline up to 10 years
measure: Maximum Serum Concentrations (Cmax) for Atezolizumab
timeFrame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
measure: Minimum Serum Concentrations (Cmin) for Atezolizumab
timeFrame: 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)
measure: Cmax for Trastuzumab Emtansine
timeFrame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
measure: Cmin for Trastuzumab Emtansine
timeFrame: 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)
measure: Cmax for Total Trastuzumab
timeFrame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
measure: Cmin for Total Trastuzumab
timeFrame: 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)
measure: Cmax for DM1
timeFrame: Day 1 of Cycles 1 and 4 after 30 minutes post-infusion (a cycle=21 days)
measure: Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab
timeFrame: 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)
measure: Percentage of Participants with ADAs to Trastuzumab Emtansine
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Buena
country: United States
facility: Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center
state: California
city: Whittier
country: United States
facility: Innovation Clinical Research Institute
state: California
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Carrollton
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Westbrook
country: United States
facility: New England Cancer Specialists
state: Maine
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: San Antonio
country: United States
facility: Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
state: Texas
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg, Inc.
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates - New Port News
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates - Virginia Beach
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Campbelltown
country: Australia
facility: Macarthur Cancer Therapy Centre
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Namur
country: Belgium
facility: Clinique St. Elizabeth
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - HSR
state: Bahia
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: Ceará
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goiás
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
state: São Paulo
city: Plovdiv
country: Bulgaria
facility: COC Plovdiv
city: Sofia
country: Bulgaria
facility: Medical Center "Nadezhda Clinical" EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Chengdu City
country: China
facility: Sichuan Cancer Hospital
city: Chengdu City
country: China
facility: West China Hospital - Sichuan University
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Guangzhou City
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: The First Affilicated Hospital, Sun Yat-sen University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Tianjing
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Brno
country: Czechia
facility: Masaryk?v onkologický ústav
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Novy Jicin
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice
city: Praha 4 - Krc
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besançon
country: France
facility: CHRU Besançon
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brest
country: France
facility: Hopital Morvan
city: Caen
country: France
facility: Centre Francois Baclesse
city: Creil Cedex 1
country: France
facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO
city: Lyon
country: France
facility: CLCC Leon Berard Lyon
city: Nimes
country: France
facility: Centre Hospitalier Uni Ire Caremeau
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses
city: Paris
country: France
facility: Institut Curie
city: Poitiers
country: France
facility: Pole Regional De Cancerologie
city: Saint-Cloud
country: France
facility: HOPITAL RENE HUGUENIN, Institut Curie
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Nauheim
country: Germany
facility: Hochwaldkrankenhaus
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Bonn
country: Germany
facility: Gynäkologisches Zentrum Bonn
city: Bottrop
country: Germany
facility: Marienhospital Bottrop
city: Dessau-Roßlau
country: Germany
facility: Städtisches Klinikum Dessau
city: Düsseldorf
country: Germany
facility: Gynonco Düsseldorf, MVZ Medical Center GmbH
city: Erfurt
country: Germany
facility: Frauenarztpraxis Dr. Apel, Dr. Kolpin
city: Essen
country: Germany
facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
city: Frankfurt
country: Germany
facility: AGAPLESION Markus-Krankenhaus
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Hannover
country: Germany
facility: Diakovere Henriettenstift, Frauenklinik
city: Kiel
country: Germany
facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
city: Lüneburg
country: Germany
facility: Städtische Klinik Lüneburg
city: München
country: Germany
facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
city: Schweinfurt
country: Germany
facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen
city: Athens
country: Greece
facility: Anticancer Hospital Ag. Savas
city: Athens
country: Greece
facility: Alexandras General Hospital of Athens
city: Crete
country: Greece
facility: University General Hospital of Heraklion
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Piraeus
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Budapest
country: Hungary
facility: Budapesti Szent Margit Korhaz
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Center
state: Delhi
city: North WEST Delhi
country: India
facility: Max Super Speciality Hospital
state: Delhi
city: Ahmadabad
country: India
facility: Hemato Oncology Clinic Ahmedabad Pvt Ltd
state: Gujarat
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Specialty Hospital Hadapsar
state: Maharashtra
city: Ratnagiri Kilminnal
country: India
facility: Christian Med Clg & Hspt
state: Tamil NADU
city: Kolkata
country: India
facility: TATA Medical Centre
state: WEST Bengal
city: Avellino
country: Italy
facility: AORN'S.G.Moscati
state: Campania
city: Napoli
country: Italy
facility: U.O.C. Oncologia Medica Senologica
state: Campania
city: Napoli
country: Italy
facility: Università degli Studi Federico II
state: Campania
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO)
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Livorno
country: Italy
facility: Ospedale Civile - Livorno
state: Toscana
city: Pisa
country: Italy
facility: Azlenda Ospendaliero-Universitaria Pisana
state: Toscana
city: Eldoret
country: Kenya
facility: International Cancer Institute (ICI)
city: Nairobi
country: Kenya
facility: Aga Khan University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: La Paz
country: Mexico
facility: Investigacion Oncofarmaceutica
state: BAJA California SUR
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Cdmx
country: Mexico
facility: Centro Medico Dalinde
state: Mexico CITY (federal District)
city: Distrito Federal
country: Mexico
facility: Instituto Nacional De Cancerologia
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Filios Alta Medicina
state: Nuevo LEON
city: Oaxaca de Juárez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: Auckland
country: New Zealand
facility: Auckland City Hospital, Cancer and Blood Research
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii Odzia? w Gliwicach
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
city: Lisboa
country: Portugal
facility: Hospital CUF Tejo
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Porto
country: Portugal
facility: IPO do Porto
city: Bucuresti
country: Romania
facility: Filantropia Clinical Hospital
city: Cluj County
country: Romania
facility: Amethyst Cluj
city: Cluj-Napoca
country: Romania
facility: Cluj-Napoca Emergency Clinical County Hospital
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncological Dispensary of the Ministry of Healthcare
state: Karelija
city: Moscow
country: Russian Federation
facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: MEDSI Clinical Hospital on Pyatnitsky Highway
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Oncology Center
state: Niznij Novgorod
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: Medical Clinic "AB Medical group"
state: Sankt Petersburg
city: St PETERBURG
country: Russian Federation
facility: SBI of Healthcare Leningrad Regional Oncology Dispensary
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
state: Sankt Petersburg
city: Kaluga
country: Russian Federation
facility: SBIH Kaluga Region Clinical Oncology Dispensary
city: Novosibirsk
country: Russian Federation
facility: LLC Medical and Sanitary Unit "Clinician"
city: Tomsk
country: Russian Federation
facility: Regional Oncology Dispensary
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera
state: Cadiz
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Quiron de Madrid
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Chia-Yi
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital
city: Taipei 100
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Songkla
country: Thailand
facility: Songklanagarind Hospital
city: Adana
country: Turkey
facility: Adana Baskent University Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty, Oncology Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
city: Bornova, ?zm?r
country: Turkey
facility: Ege University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle University Faculty of Medicine
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Faculty of Medicine
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital.
city: Izmir
country: Turkey
facility: Katip Celebi University Ataturk Training and Research Hospital
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty of Medicine
city: Seyhan
country: Turkey
facility: Medical Park Seyhan Hospital
city: Üsküdar
country: Turkey
facility: Ac?badem Altunizade Hastanesi
city: Kampala
country: Uganda
facility: Uganda Cancer Institute
city: Uzhhorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital
state: Katerynoslav Governorate
city: Kharkiv
country: Ukraine
facility: Municipal Noncommercial Institution Regional Center of Oncology
state: Kharkiv Governorate
city: Sumy
country: Ukraine
facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
state: Kholm Governorate
city: Dnipropetrovsk
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
city: Kirovograd
country: Ukraine
facility: Municipal Institution Kirovograd Regional Oncology Dispensary
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: London
country: United Kingdom
facility: Barts & London School of Med
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.