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)
NCT ID: NCT04740918
Last Updated: 2025-08-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
96 participants
INTERVENTIONAL
2021-06-07
2024-06-19
Brief Summary
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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: Trastuzumab Emtansine and Placebo
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Placebo
Placebo matched to atezolizumab
Arm B: Trastuzumab Emtansine and Atezolizumab
Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Atezolizumab
Atezolizumab 1200 mg IV infusion
Interventions
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Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Atezolizumab
Atezolizumab 1200 mg IV infusion
Placebo
Placebo matched to atezolizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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Emad Ibrahim, Md, Inc
Redlands, California, United States
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, Brazil
Royal Victoria Hospital
Barrie, Ontario, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, Canada
Peking University People's Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjing, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
Clinica Vida
Medellín, , Colombia
Oncomedica S.A.
Montería, , Colombia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Helsinki University Central Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Institut Curie - Hopital Rene Huguenin
Saint-Cloud, , France
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino, Campania, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Napoli, Campania, Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
Oslo Universitetssykehus HF
Oslo, , Norway
Cebu Doctors' University Hospital
Cebu City, , Philippines
St. Luke's Medical Center
Quezon City, , Philippines
Cardinal Santos Medical Center
San Juan City, , Philippines
Opolskie Centrum Onkologii
Opole, , Poland
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, , Poland
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, , Portugal
IPO do Porto
Porto, , Portugal
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, Bashkortostan Republic, Russia
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario La Paz
Madrid, , Spain
Adana Baskent University Medical Faculty
Adana, , Turkey (Türkiye)
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Adapazari/Sakarya, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, , Turkey (Türkiye)
Acibadem University School of Medicine Altunizade Hospital Oncology Service
Istanbul, , Turkey (Türkiye)
Katip Celebi University Ataturk Training and Research Hospital
Izmir, , Turkey (Türkiye)
Kayseri Acibadem Hospital
Kayseri, , Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, , Turkey (Türkiye)
UCL Hospital NHS Trust
London, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Nottingham University Hospitals City Campus
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-002818-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO42319
Identifier Type: -
Identifier Source: org_study_id
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