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

NCT04873362 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: WO426332020-003681-402023-503568-18-00
• Study Type: interventional
• Target: 1,188
• Locations: 31 countries
• Sites: 235

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (18)

• IDFS Including Second Primary Non-breast Invasive Cancer

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

• IDFS in the PD-L1-positive and the PD-L1-negative Population

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

• Disease-free Survival (DFS)

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

• Overall Survival (OS)

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

• Distant Recurrence-free Interval (DRFI)

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

Study Arms (2)

Arm A: Placebo + Trastuzumab Emtansine

ACTIVE COMPARATOR

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; Drug: Placebo; Drug: Trastuzumab

Arm B: Atezolizumab + Trastuzumab Emtansine

EXPERIMENTAL

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: Atezolizumab; Drug: Trastuzumab Emtansine; Drug: Trastuzumab

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq, RO5541267, MPDL3280A

Arm B: Atezolizumab + Trastuzumab Emtansine

Trastuzumab Emtansine DRUG

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

Also known as: Kadcyla, T-DM1, RO5304020

Arm A: Placebo + Trastuzumab Emtansine; Arm B: Atezolizumab + Trastuzumab Emtansine

Placebo DRUG

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

Arm A: Placebo + Trastuzumab Emtansine

Trastuzumab DRUG

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.

Also known as: Herceptin

Arm A: Placebo + Trastuzumab Emtansine; Arm B: Atezolizumab + Trastuzumab Emtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (238)

Alabama Oncology

Birmingham, Alabama, 35205, United States

Location

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

Buena, California, 91505, United States

Location

UCLA Medical Center

Santa Monica, California, 90404, United States

Location

Innovation Clinical Research Institute

Whittier, California, 90603, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Carrollton, Georgia, 30117, United States

Location

University of Iowa

Iowa City, Iowa, 52242-1086, United States

Location

New England Cancer Specialists

Westbrook, Maine, 04092, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

Philadelphia, Pennsylvania, 19106, United States

Location

The West Clinic

Germantown, Tennessee, 38138, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916-2305, United States

Location

Mays Cancer Center at UT Health San Antonio MD Anderson Cancer

San Antonio, Texas, 78229, United States

Location

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, 22408, United States

Location

Virginia Oncology Associates - New Port News

Newport News, Virginia, 23606, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23229, United States

Location

Virginia Oncology Associates - Virginia Beach

Virginia Beach, Virginia, 23456, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336-7774, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Macarthur Cancer Therapy Centre

Campbelltown, New South Wales, 2560, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Tiroler Landeskrankenanstalten Ges.M.B.H.

Innsbruck, 6020, Austria

Location

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010, Austria

Location

Lkh Salzburg - Univ. Klinikum Salzburg

Salzburg, 5020, Austria

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

Location

Clinique St. Elizabeth

Namur, 5000, Belgium

Location

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-550, Brazil

Location

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital Araujo Jorge

Goiânia, Goiás, 74605-070, Brazil

Location

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Base de Sao Jose do Rio Preto

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

Location

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

São Paulo, São Paulo, 01317-001, Brazil

Location

Núcleo de Pesquisa São Camilo

São Paulo, São Paulo, 03102-002, Brazil

Location

COC Plovdiv

Plovdiv, 4004, Bulgaria

Location

Medical Center "Nadezhda Clinical" EOOD

Sofia, 1330, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, 1527, Bulgaria

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

West China Hospital - Sichuan University

Chengdu, 610047, China

Location

Chongqing Cancer Hospital

Chongqing, 400030, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, 510000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510245, China

Location

The First Affilicated Hospital, Sun Yat-sen University

Guangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022, China

Location

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

Xi'an, 710061, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Masaryk?v onkologický ústav

Brno, 656 53, Czechia

Location

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, 741 01, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Fakultni Poliklinika Vseobecne Fakultni Niemocnice

Prague, 128 08, Czechia

Location

Fakultni Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

CHRU Besançon

Besançon, 25030, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

CHU Brest Hopital La Cavale Blanche

Brest, 29609, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Groupe Hospitalier Public Du Sud De L'Oise GHPSO

Creil, 60109, France

Location

CLCC Leon Berard Lyon

Lyon, 69008, France

Location

Centre Hospitalier Uni Ire Caremeau

Nîmes, 30029, France

Location

Groupe Hospitalier Diaconesses

Paris, 75020, France

Location

Institut Curie

Paris, 75231, France

Location

Pole Regional De Cancerologie

Poitiers, 86021, France

Location

HOPITAL RENE HUGUENIN, Institut Curie

Saint-Cloud, 92210, France

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Hochwaldkrankenhaus

Bad Nauheim, 61231, Germany

Location

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, 10707, Germany

Location

Gynäkologisches Zentrum Bonn

Bonn, 53111, Germany

Location

Knappschaft Kliniken Marienhospital Bottrop

Bottrop, 46236, Germany

Location

Städtisches Klinikum Dessau

Dessau, 06847, Germany

Location

Gynonco Düsseldorf, MVZ Medical Center GmbH

Düsseldorf, 40235, Germany

Location

Frauenarztpraxis Dr. Apel, Dr. Kolpin

Erfurt, 99084, Germany

Location

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

Essen, 45136, Germany

Location

AGAPLESION Markus-Krankenhaus

Frankfurt, 60431, Germany

Location

Klinik Johann Wolfgang von Goethe Uni

Frankfurt, 60596, Germany

Location

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, 79110, Germany

Location

Diakovere Henriettenstift, Frauenklinik

Hanover, 30171, Germany

Location

UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

Kiel, 24105, Germany

Location

Städtische Klinik Lüneburg

Lüneburg, 21339, Germany

Location

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

München, 80336, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

Location

Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

Schweinfurt, 97422, Germany

Location

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

Westerstede, 26655, Germany

Location

Anticancer Hospital Ag. Savas

Athens, 115 22, Greece

Location

Alexandras General Hospital of Athens

Athens, 115 28, Greece

Location

University General Hospital of Heraklion

Crete, 711 10, Greece

Location

University Hospital of Larissa

Larissa, 411 10, Greece

Location

Metropolitan Hospital

Piraeus, 185 47, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 570 01, Greece

Location

Queen Mary Hospital

Hong Kong, 852, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Budapesti Szent Margit Korhaz

Budapest, 1032, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Hemato Oncology Clinic Ahmedabad Pvt Ltd

Ahmedabad, Gujarat, 380054, India

Location

Manipal Hospital

Bangalore, Karnataka, 560017, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

Location

Sahyadri Super Specialty Hospital Hadapsar

Pune, Maharashtra, 411028, India

Location

Rajiv Gandhi Cancer Institute & Research Center

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Max Super Speciality Hospital

North WEST Delhi, National Capital Territory of Delhi, 110088, India

Location

Christian Med Clg & Hspt

Ratnagiri Kilminnal, Tamil Nadu, 632517, India

Location

TATA Medical Centre

Kolkata, West Bengal, 700156, India

Location

AORN'S.G.Moscati

Avellino, Campania, 83100, Italy

Location

U.O.C. Oncologia Medica Senologica

Naples, Campania, 80131, Italy

Location

Università degli Studi Federico II

Naples, Campania, 80131, Italy

Location

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, 41100, Italy

Location

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, 25123, Italy

Location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, 20133, Italy

Location

Ospedale Civile - Livorno

Livorno, Tuscany, 57124, Italy

Location

Azlenda Ospendaliero-Universitaria Pisana

Pisa, Tuscany, 56100, Italy

Location

The Aga Khan University-Kenya.

Nairobi, 00100, Kenya

Location

Investigacion Oncofarmaceutica

La Paz, Baja California Sur, 23040, Mexico

Location

Instituto Nacional De Cancerologia

Distrito Federal, Mexico CITY (federal District), 14000, Mexico

Location

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), 03100, Mexico

Location

Centro Medico Dalinde

Mexico City, Mexico CITY (federal District), 06760, Mexico

Location

Filios Alta Medicina

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Oaxaca, 68020, Mexico

Location

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

Location

Bialostockie Centrum Onkologii

Bialystok, 15-027, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

Location

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, 44-102, Poland

Location

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Location

Wielkopolskie Centrum Onkologii

Poznan, 61-866, Poland

Location

Centrum Onkologii Instytut im.M. Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Hospital CUF Tejo

Lisbon, 1350-352, Portugal

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Beatriz Angelo

Loures, 2674-514, Portugal

Location

IPO do Porto

Porto, 4200-072, Portugal

Location

Filantropia Clinical Hospital

Bucharest, 021164, Romania

Location

Amethyst Cluj

Cluj County, 407280, Romania

Location

Cluj-Napoca Emergency Clinical County Hospital

Cluj-Napoca, 400006, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Centrul de Oncologie Sfantul Nectarie

Craiova, 200347, Romania

Location

Oncomed SRL

Timișoara, 300239, Romania

Location

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

Moscow, Moscow Oblast, 115478, Russia

Location

MEDSI Clinical Hospital on Pyatnitsky Highway

Moscow, Moscow Oblast, 143422, Russia

Location

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

Moskva, Moscow Oblast, 111123, Russia

Location

Nizhny Novgorod Regional Clinical Oncology Center

Nizhny Novgorod, Niznij Novgorod, 603126, Russia

Location

Republican Clinical Oncological Dispensary of the Ministry of Healthcare

Kazan, Republic of Karelia, 420029, Russia

Location

SBI of Healthcare Leningrad Regional Oncology Dispensary

Saint Peterburg, Sankt-Peterburg, 191104, Russia

Location

Medical Clinic "AB Medical group"

Saint Petersburg, Sankt-Peterburg, 196006, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

SBIH Kaluga Region Clinical Oncology Dispensary

Kaluga, 248007, Russia

Location

LLC Medical and Sanitary Unit "Clinician"

Novosibirsk, 630099, Russia

Location

Regional Oncology Dispensary

Tomsk, 634063, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, 150040, Russia

Location

National Cancer Centre

Singapore, 168583, Singapore

Location

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Samsung Medical Center

Seoul, (0)6351, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital de Jerez de la Frontera

Jerez de la Frontera, Cadiz, 11407, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

Location

Hospital Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

Jaén, 23007, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Quiron de Madrid

Madrid, 28223, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Cheng Kung Uni Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 00112, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Adana Baskent University Hospital

Adana, 01120, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Ankara, 06490, Turkey (Türkiye)

Location

Gazi University Medical Faculty, Oncology Hospital

Ankara, 06500, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Location

Ege University Medical Faculty

Bornova, ?zm?r, 35100, Turkey (Türkiye)

Location

Dicle University Faculty of Medicine

Diyarbakır, 21280, Turkey (Türkiye)

Location

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

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Faculty of Medicine

Istanbul, 34098, Turkey (Türkiye)

Location

Medeniyet University Goztepe Training and Research Hospital.

Istanbul, 34730, Turkey (Türkiye)

Location

Katip Celebi University Ataturk Training and Research Hospital

Izmir, 35360, Turkey (Türkiye)

Location

Inonu University Medical Faculty of Medicine

Malatya, 44280, Turkey (Türkiye)

Location

Medical Park Seyhan Hospital

Seyhan, 01140, Turkey (Türkiye)

Location

Ac?badem Altunizade Hastanesi

Üsküdar, 34662, Turkey (Türkiye)

Location

Uganda Cancer Institute

Kampala, 00256, Uganda

Location

Uzhgorod Central City Clinical Hospital

Uzhhorod, Katerynoslav Governorate, 88000, Ukraine

Location

Municipal Noncommercial Institution Regional Center of Oncology

Kharkiv, Kharkiv Governorate, 61070, Ukraine

Location

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

Sumy, Kholm Governorate, 40005, Ukraine

Location

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

Dnipropetrovsk, 49102, Ukraine

Location

Municipal Institution Kirovograd Regional Oncology Dispensary

Kirovograd, 25011, Ukraine

Location

Kyiv City Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

Blackpool Victoria Hospital

Blackpool, FY3 8NR, United Kingdom

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, GL53 7AN, United Kingdom

Location

Barts & London School of Med

London, EC1A 7BE, United Kingdom

Location

University College London Hospital

London, NW1 - 2PG, United Kingdom

Location

Royal Free Hospital

London, NW3 2QS, United Kingdom

Location

Royal Marsden Hospital - London

London, SW3 6JJ, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36382554 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

atezolizumab; Ado-Trastuzumab Emtansine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 5, 2021
• Study Start: May 4, 2021
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): October 2, 2034
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

UA (6); ME (6); TU (16); SG (1); BU (3); KR (10); FR (12); US (22); UG (1); GB (12); ES (19); BR (10); RU (13); IT (11); TW (5); CZ (6); BE (3); HU (3); AU (3); HK (3); CN (13); GR (6); IN (9); NZ (1); RO (6); PL (6); DE (19); DK (1); PT (4); TH (4); KE (1)