A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
NCT ID: NCT03125902
Last Updated: 2024-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
653 participants
INTERVENTIONAL
2017-08-25
2023-01-17
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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Placebo and Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Paclitaxel
Paclitaxel will be administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Atezolizumab Placebo
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Paclitaxel
Paclitaxel will be administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Interventions
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Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Atezolizumab Placebo
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Paclitaxel
Paclitaxel will be administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants eligible for taxane monotherapy
* No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
* Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 17 unstained slides, collected ≤3 months prior to randomization, with an associated pathology report, if available. If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used.
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Life expectancy at least 12 weeks
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end-organ function
* Negative human immunodeficiency virus (HIV) test at screening.
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test.
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
* Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
* For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo, or for at least 6 months after the last dose of paclitaxel
Exclusion Criteria
* Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia
* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
* Pregnant or breast-feeding women, or intending to become pregnant during the study
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)
* Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
* Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis
* Treatment with investigational therapy within 30 days prior to initiation of study treatment
* History of hypersensitivity reactions to study drug or any component of the study drug formulation
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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Stanford Cancer Center
Stanford, California, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
HCA Midwest Health
Kansas City, Missouri, United States
The Valley Hospital
Paramus, New Jersey, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Oncology; Sarah Cannon Research Institute
Nashville, Tennessee, United States
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Perola Byington
São Paulo, São Paulo, Brazil
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Grand River Hospital
Kitchener, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
McGill University; Glen Site; Oncology
Montreal, Quebec, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, , China
Beijing Union Hospital
Beijing, , China
West China Hospital, Sichuan University; Department of Breast
Chengdu, , China
Sun Yat-sen Memorial Hospital
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Shandong Cancer Hospital
Jinan, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Liaoning cancer Hospital & Institute
Shenyang, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, , Czechia
Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
Ostrava-Poruba, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, , Czechia
Clinique Sainte Catherine; Hopital De Semaine
Avignon, , France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hopital Morvan
Brest, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
Centre Oscar Lambret; Senologie
Lille, , France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, , France
Centre D'Oncologie de Gentilly; Oncology
Nancy, , France
Hopital Caremeau; Hematologie Oncologie
Nîmes, , France
Hopital Tenon
Paris, , France
Institut Curie; Oncologie Medicale
Paris, , France
Hopital Saint Louis, Service D Oncologie Medicale
Paris, , France
Ch Pitie Salpetriere; Oncologie Medicale
Paris, , France
Centre Eugene Marquis; Service d'oncologie
Rennes, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, , France
Institut Gustave Roussy; Sitep
Villejuif, , France
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin, , Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, , Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, , Germany
HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, , Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, , Germany
OnkoNet Marburg GmbH
Marburg, , Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, , Germany
Klinikum Ernst von Bergmann; Frauenklinik
Potsdam, , Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, , Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, , Germany
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, , Greece
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
Athens, , Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, , Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, , Greece
Yashoda Hospital
Hyderabad, Andhra Pradesh, India
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, India
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, India
Jehangir Hospital
Pune, Maharashtra, India
Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, India
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, National Capital Territory of Delhi, India
Apollo Speciality Hospital
Chennai, Tamil Nadu, India
Apollo Gleneagles Hospitals
Kolkata, West Bengal, India
TATA Medical Centre; Medical Oncology
Kolkata, West Bengal, India
MAX Balaji Hospital
Delhi, , India
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Rambam Health Corporation; Oncology Institute
Rambam, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, , Israel
Assaf Harofeh; Oncology
Ẕerifin, , Israel
Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
Chieti, Abruzzo, Italy
Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
Frattamaggiore, Campania, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, Italy
Universita Campus Bio-Medico di Roma (UCBM)
Rome, Lazio, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Rome, Lazio, Italy
Azienda Policlinico Umberto I
Rome, Lazio, Italy
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
Hospital San Raffaele
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
Milan, Lombardy, Italy
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano (MI), Lombardy, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, Italy
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicily, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Florence, Tuscany, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Tuscany, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padua, Veneto, Italy
Gunma Prefectural Cancer Center
Gunma, , Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
Sagara Hospital
Kagoshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Tokai University Hospital
Kanagawa, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Naha-nishi Clinic
Okinawa, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Saitama Cancer Center
Saitama, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakesh, , Morocco
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
Rabat, , Morocco
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, , Romania
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, Moscow Oblast, Russia
Petrov Research Inst. of Oncology
Saint Petersburg, , Russia
King Fahad Specialist Hospital; Oncology
Dammam, , Saudi Arabia
International Medical Center (IMC)
Jeddah, , Saudi Arabia
King Fahad Medical City; Gastroentrology
Riyadh, , Saudi Arabia
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
Bratislava, , Slovakia
POKO Poprad; Department of Oncology
Poprad, , Slovakia
Wilgers Oncology Centre
Pretoria, , South Africa
Private Oncology Centre
Pretoria, , South Africa
Sandton Oncology Medical Group
Sandton, , South Africa
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, , Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, , Spain
Adana Baskent University Medical Faculty; Oncology
Adana, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Uludag University Medical Faculty; Internal Medicine
Bursa, , Turkey (Türkiye)
Dicle Uni Medical Faculty; Internal Medicine
Diyarbakır, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, , Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, , Turkey (Türkiye)
Kocaeli University Faculty of Medicine; Medical oncology
İzmit, , Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy, , Turkey (Türkiye)
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
K hospital
Hanoi, , Vietnam
Hochiminh city oncology hospital
Hochiminh City, , Vietnam
Countries
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References
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Miles D, Gligorov J, Andre F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Additional information for the IMpassion131
general information on clinical trials
Other Identifiers
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2016-004024-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO39196
Identifier Type: -
Identifier Source: org_study_id
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