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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04740918
Other study ID # MO42319
Secondary ID 2020-002818-41
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 7, 2021
Est. completion date April 30, 2024

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 96
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Atezolizumab
Atezolizumab 1200 mg IV infusion
Other:
Placebo
Placebo matched to atezolizumab

Locations

Country Name City State
Australia Lake Macquarie Private Hospital Gateshead New South Wales
Australia Peter MacCallum Cancer Center North Melbourne Victoria
Australia Sunshine Hospital St Albans Victoria
Australia Royal North Shore Hospital; Oncology St. Leonards New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Brazil Hospital Araujo Jorge; Departamento de Ginecologia E Mama Goiania GO
Brazil Hospital de Caridade de Ijui; Oncologia Ijui RS
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre RS
Brazil Hospital do Cancer de Pernambuco - HCP Recife PE
Brazil Hospital Sao Rafael - HSR Salvador BA
Brazil Hospital de Base de Sao Jose do Rio Preto Sao Jose do Rio Preto SP
Brazil Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda Sao Paulo SP
Brazil Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA Sao Paulo SP
Canada Royal Victoria Hospital Barrie Ontario
Canada Centre Hospitalier de l?Université de Montréal (CHUM) Montreal Quebec
Canada McGill University Health Center Montreal Quebec
Canada Jewish General Hospital; Research Unit Montréal Quebec
Canada Lakeridge Health Oshawa; Oncology Oshawa Ontario
Canada The Ottawa Hospital Cancer Centre; Oncology Ottawa Ontario
Canada CHUS (Centre Hospitalier Universitaire de Sherbrooke) Sherbrooke Quebec
Canada Sunnybrook Research Institute Toronto Ontario
China Beijing Cancer Hospital Beijing
China Peking University People's Hospital Beijing
China The First Hospital of Jilin University Changchun City
China Hunan Cancer Hospital Changsha CITY
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center Guangzhou City
China Zhejiang Provincial People's Hospital; Oncology& Breast Hangzhou
China Harbin Medical University Cancer Hospital Harbin
China Yunnan Cancer Hospital; Breast Surgery Kunming City
China Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Nanjing City
China Peking University Shenzhen Hospital Shenzhen
China Tianjin Medical University Cancer Institute & Hospital Tianjin
China Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan City
China Shanxi Provincial People's Hospital Xian
China Zhejiang Cancer Hospital Zhejiang
China Henan Cancer Hospital Zhengzhou
Colombia Clinica Vida Medellin
Colombia Oncomedica S.A. Monteria
Colombia Oncólogos de Occidente Pereira
Croatia Clinical Hospital Centre Split Split
Croatia Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors Zagreb
Croatia Clinical Hospital Centre Zagreb Zagreb
Finland Helsinki University Central Hospital; Dept of Oncology Helsinki
Finland Oulu University Hospital; Oncology Oulu
Finland Tampere University Hospital; Dept of Oncology Tampere
France CHU Amiens - Hopital Sud Amiens
France Polyclinique Bordeaux Nord Aquitaine Bordeaux
France Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie Grenoble
France Centre Oscar Lambret; Senologie Lille
France Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice Nice
France Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly) Paris
France Chu La Miletrie; Oncologie Medicale Poitiers
France Institut Curie - Hopital Rene Huguenin Saint-Cloud
France Institut Universitaire du Cancer de Toulouse-Oncopole Toulouse
Greece Alexandras General Hospital of Athens; Oncology Department Athens
Greece Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine Athens
Greece University General Hospital of Heraklion;Internal Medicine-Oncology Clinic Heraklion, Crete
Greece Euromedical General Clinic of Thessaloniki; Oncology Department Thessaloniki
Italy Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati Avellino Campania
Italy Azienda Ospedaliera S. Orsola-Malpighi Bologna Emilia-Romagna
Italy Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica Napoli Campania
Italy Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS Reggio Emilia Emilia-Romagna
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Norway Oslo Universitetssykehus HF; Ullevål sykehus Oslo
Philippines Cebu Doctors' University Hospital; Research Office Cebu City
Philippines St. Luke's Medical Center; Human Cancer Biobank Research Center Quezon City
Philippines Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center San Juan
Poland Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna ?ód?
Poland Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii Gdansk
Poland Przychodnia Lekarska KOMED, Roman Karaszewski Konin
Poland Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii Kraków
Poland Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej Opole
Poland Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna Poznan
Poland Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii Warszawa
Poland Mazowiecki Szpital Onkologiczny Wieliszew
Portugal Hospital de Santa Maria; Servico de Oncologia Medica Lisboa
Portugal IPO de Lisboa; Servico de Oncologia Medica Lisboa
Portugal Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia Porto
Portugal IPO do Porto; Servico de Oncologia Medica Porto
Russian Federation FSBSI ?N. N. Blokhin Russian Cancer Research Center? Moscow Moskovskaja Oblast
Russian Federation City Clinical Oncology Dispensary, SPb SBIH CCOD Saint-Petersburg Sankt Petersburg
Russian Federation Samara Regional Oncology Dispensary Samara
Russian Federation State Healthcare Institution ?Regional Clinical Oncology Dispensary? Saratov
Russian Federation St. Petersburg Clinical Scientific Center of special services medical assis (oncology) ST Petersburg Sankt Petersburg
Russian Federation SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan Ufa Baskortostan
Slovenia Institute of Oncology Ljubljana Ljubljana
Spain Hospital Universitari Vall d'Hebron; Oncology Barcelona
Spain Hospital Provincial de Castellon; Servicio de Oncologia Castellon de La Plana Castellon
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Spain Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Malaga
Spain Hospital Universitario Quiron Madrid; Servicio de Oncologia Pozuelo de Alarcón Madrid
Spain Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla
Spain Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología Vigo Pontevedra
Turkey Adana Baskent University Medical Faculty; Oncology Adana
Turkey Sakarya Universitesi Egitim ve Arastirma Hastanesi Adapazari/Sakarya
Turkey Memorial Ankara Hastanesi Ankara
Turkey Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji Bakirkoy / Istanbul
Turkey Acibadem University School of Medicine Altunizade Hospital Oncology Service Istanbul
Turkey Katip Celebi University Ataturk Training and Research Hospital; Oncology Izmir
Turkey Kayseri Acibadem Hospital Kayseri
Turkey Hacettepe Uni Medical Faculty Hospital; Oncology Dept Sihhiye/Ankara
United Kingdom Leicester Royal Infirmary NHS Trust Leicester
United Kingdom Guys and St Thomas NHS Foundation Trust, Guys Hospital London
United Kingdom UCL Hospital NHS Trust London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Milton Keynes University Hospital Milton Keynes
United Kingdom Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team Nottingham
United States Emad Ibrahim, Md, Inc Redlands California

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Colombia,  Croatia,  Finland,  France,  Greece,  Italy,  Korea, Republic of,  Norway,  Philippines,  Poland,  Portugal,  Russian Federation,  Slovenia,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Following the Sponsor's decision to prematurely terminate the study, no formal testing will be performed and the outcome measure will only be reported in a descriptive way. Baseline until disease progression, death or end of study (approximately 78 months)
Primary Overall Survival (OS) Following the Sponsor's decision to prematurely terminate the study, no formal testing will be performed and the outcome measure will only be reported in a descriptive way. From baseline until death or end of study (approximately 78 months)
Secondary Percentage of Participants With Objective Response Rate (ORR) as Determined by Investigator's Assessment Using RECIST v1.1 Baseline until disease progression, death or end of study (approximately 78 months)
Secondary Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1 Baseline until disease progression, death or end of study (approximately 78 months)
Secondary PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1 Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted. Baseline until disease progression, death or end of study (approximately 78 months)
Secondary PFS in Participants with Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1 Baseline until disease progression, death or end of study (approximately 78 months)
Secondary OS in Participants with Baseline Brain Metastases From baseline until death or end of study (approximately 78 months)
Secondary Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases Baseline until disease progression, death or end of study (approximately 78 months)
Secondary Mean Absolute Scores in Function (Physical, Role) and Global Health Status (GHS)/Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted. From Cycle 1 until 3 months after study completion
Secondary Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30 Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted. From Cycle 1 until 3 months after study completion
Secondary Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30 Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted. From Cycle 1 until 3 months after study completion
Secondary Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Baseline up to end of study (approximately 78 months)
Secondary Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed. Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Secondary Cmax of Atezolizumab Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed. Day 1 of Cycles 1, 2, 3, 4 and 8 and every 8 cycles thereafter (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Secondary Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed. Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Secondary Percentage of Participants With ADAs to Atezolizumab Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed. Day 1 of Cycles 1, 2, 3, 4 and 8 and every 8 cycles thereafter (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
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