Breast Cancer Clinical Trial

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

Summary

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
No more than two prior lines of therapy in the metastatic setting
Measurable disease per RESIST version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy >= 6 months
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

Prior treatment with trastuzumab emtansine in metastatic setting
History of exposure to cumulative doses of anthracyclines
Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
Current Grade >= 3 peripheral neuropathy
Cardiopulmonary dysfunction
History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
Active hepatitis B, hepatitis C and/or tuberculosis
Prior allogeneic stem cell or solid organ transplantation
Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
Pregnancy or lactation

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

320

Study ID:

NCT04740918

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 137 Locations for this study

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Orange Coast Memorial Medical Center
Fountain Valley California, 92708, United States
Emad Ibrahim, Md, Inc
Redlands California, 92373, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Mercy Health Research
Saint Louis Missouri, 63141, United States
San Juan Oncology Associates, PC
Farmington New Mexico, 87401, United States
Clinical Research Alliance
Westbury New York, 11590, United States
Magee Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Lake Macquarie Private Hospital
Gateshead New South Wales, 2290, Australia
Royal North Shore Hospital; Oncology
St. Leonards New South Wales, 2065, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
Hospital Sao Rafael - HSR
Salvador BA, 41253, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania GO, 74605, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife PE, 50040, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui RS, 98700, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto SP, 15090, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Sao Paulo SP, 01317, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
Sao Paulo SP, 04014, Brazil
Royal Victoria Hospital
Barrie Ontario, L4M 6, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa Ontario, K1H 8, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal Quebec, H2X 0, Canada
McGill University Health Center
Montreal Quebec, H4A 3, Canada
Jewish General Hospital; Research Unit
Montréal Quebec, H3T 1, Canada
CHUS (Centre Hospitalier Universitaire de Sherbrooke)
Sherbrooke Quebec, J1H 5, Canada
Peking University People's Hospital
Beijing , 10004, China
Beijing Cancer Hospital
Beijing , 10014, China
The First Hospital of Jilin University
Changchun City , 13002, China
Hunan Cancer Hospital
Changsha City , 41001, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center
Guangzhou City , 51012, China
The Second Affiliated Hospital, Zhejiang University
Hangzhou , 31000, China
Zhejiang Provincial People's Hospital; Oncology& Breast
Hangzhou , 31001, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Yunnan Cancer Hospital; Breast Surgery
Kunming City , 65010, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing City , 21002, China
Peking University Shenzhen Hospital
Shenzhen , 51803, China
Tianjin Medical University Cancer Institute & Hospital
Tianjing , 30006, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City , 43002, China
Shanxi Provincial People's Hospital
Xian , 71006, China
Zhejiang Cancer Hospital
Zhejiang , 31002, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Clinica Vida
Medellin , , Colombia
Oncomedica S.A.
Monteria , 23000, Colombia
Oncólogos de Occidente
Pereira , 60000, Colombia
Clinical Hospital Centre Split
Split , 21000, Croatia
Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors
Zagreb , 10000, Croatia
Clinical Hospital Centre Zagreb
Zagreb , 10000, Croatia
Helsinki University Central Hospital; Dept of Oncology
Helsinki , 00250, Finland
Oulu University Hospital; Oncology
Oulu , 90029, Finland
Tampere University Hospital; Dept of Oncology
Tampere , 33520, Finland
CHU Amiens - Hopital Sud
Amiens , 80054, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux , 33300, France
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble , 38043, France
Centre Oscar Lambret; Senologie
Lille , 59020, France
Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
Nice , 06189, France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly)
Paris , 75020, France
Chu La Miletrie; Oncologie Medicale
Poitiers , 86021, France
Institut Curie - Hopital Rene Huguenin
Saint-Cloud , 92211, France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse , 31059, France
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre-les-nancy , 54519, France
Onkozentrum Dres. Göhler
Dresden , 01127, Germany
Diakovere Henriettenstift, Frauenklinik
Hannover , 30559, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg , 69120, Germany
St. Elisabeth-Krankenhaus; Brustzentrum
Köln , 50935, Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens , 115 2, Greece
Alexandras General Hospital of Athens; Oncology Department
Athens , 115 2, Greece
University General Hospital of Heraklion;Internal Medicine-Oncology Clinic
Heraklion, Crete , 711 1, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki , 546 4, Greece
Szent Margit Hospital
Budapest , 1032, Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest , 1122, Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen , 4032, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc , 3501, Hungary
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino Campania, 83100, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli Campania, 80131, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli Campania, 80131, Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna Emilia-Romagna, 40138, Italy
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
Reggio Emilia Emilia-Romagna, 42123, Italy
Ospedale Policlinico San Martino; Ist. di Ricovero e Cura a Carattere Scientifico per l'Oncologia
Genova Liguria, 16132, Italy
Asst Papa Giovanni XXIII
Bergamo Lombardia, 24100, Italy
Ospedale San Raffaele; Medical Oncology
Milano Lombardia, 20132, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano Lombardia, 20089, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56100, Italy
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
Haukeland universitetssjukehus, Avd. for kreftbehandling og medisinsk fysikk
Bergen , 5021, Norway
Sykehuset Østfold Kalnes; Onkologisk seksjon
Grålum , 1714, Norway
Oslo Universitetssykehus HF; Ullevål sykehus
Oslo , 0450, Norway
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger , 4011, Norway
Cebu Doctors' University Hospital; Research Office
Cebu City , 6000, Philippines
St. Luke's Medical Center; Human Cancer Biobank Research Center
Quezon City , 1102, Philippines
Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center
San Juan , 1502, Philippines
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk , 80-21, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin , 62-50, Poland
Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii
Koszalin , 75-58, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Kraków , 30-68, Poland
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz , 90-24, Poland
Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
Opole , 45-06, Poland
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
Poznan , 60-56, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warszawa , 02-78, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew , 05-13, Poland
IPO de Lisboa; Servico de Oncologia Medica
Lisboa , 1099-, Portugal
Centro Clinico Champalimaud; Oncologia Medica
Lisboa , 1400-, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisboa , 1649-, Portugal
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia
Porto , 4099-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
FSBSI "N. N. Blokhin Russian Cancer Research Center"
Moscow , 11547, Russian Federation
City Clinical Oncology Dispensary, SPb SBIH CCOD
Saint-Petersburg , 19825, Russian Federation
Samara Regional Oncology Dispensary
Samara , 44303, Russian Federation
State Healthcare Institution "Regional Clinical Oncology Dispensary"
Saratov , 41005, Russian Federation
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
ST Petersburg , 19775, Russian Federation
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa , 45005, Russian Federation
Institute of Oncology Ljubljana
Ljubljana , 1000, Slovenia
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon de La Plana Castellon, 12002, Spain
Hospital Universitario Quiron Madrid; Servicio de Oncologia
Pozuelo de Alarcón Madrid, 28223, Spain
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
Vigo Pontevedra, 36312, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga , 29011, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Adana Baskent University Medical Faculty; Oncology
Adana , 01220, Turkey
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Adapazari/Sakarya , 54100, Turkey
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul , 34147, Turkey
Acibadem University School of Medicine Altunizade Hospital Oncology Service
Istanbul , 34742, Turkey
Katip Celebi University Ataturk Training and Research Hospital; Oncology
Izmir , 35360, Turkey
Kayseri Acibadem Hospital
Kayseri , 38000, Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
Malatya , 44280, Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara , 06230, Turkey
Leicester Royal Infirmary NHS Trust
Leicester , LE1 5, United Kingdom
UCL Hospital NHS Trust
London , NW1 2, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London , SE1 9, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Milton Keynes University Hospital
Milton Keynes , MK6 5, United Kingdom
Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team
Nottingham , NG5 1, United Kingdom
Peterborough City Hospital
Peterborough , PE3 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

320

Study ID:

NCT04740918

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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