A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
IMpassion131
A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer
2 other identifiers
interventional
653
24 countries
161
Brief Summary
This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2017
Longer than P75 for phase_3
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedStudy Start
First participant enrolled
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2019
CompletedResults Posted
Study results publicly available
January 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2023
CompletedMarch 26, 2024
March 1, 2024
2.2 years
April 20, 2017
November 10, 2020
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Secondary Outcomes (20)
Overall Survival (OS) in the PD-L1-Positive Subpopulation
From Day 1 to death from any cause, assessed up 36 months
Overall Survival (OS) in the ITT Population
From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
Percentage of Participants Who Are Alive at 12 and 18 Months
From Day 1 to death from any cause, assessed up to 12 and 18 months
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
From Day 1 to deterioration, assessed up 64 months
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
From Day 1 to PD or death from any cause, assessed up to 12 months
- +15 more secondary outcomes
Study Arms (2)
Placebo and Paclitaxel
PLACEBO COMPARATORParticipants 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 and Paclitaxel
EXPERIMENTALParticipants 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.
Interventions
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.
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
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.
Eligibility Criteria
You may qualify if:
- Participants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PR\] expression), not amenable to surgical therapy
- 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
You may not qualify if:
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (161)
Stanford Cancer Center
Stanford, California, 94305-5820, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, 33901-8101, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060, United States
HCA Midwest Health
Kansas City, Missouri, 64132, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Tennessee Oncology; Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, 40050-410, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, 74605-070, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 90040-373, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Grand River Hospital
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University; Glen Site; Oncology
Montreal, Quebec, H4A 3J1, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Beijing Union Hospital
Beijing, 100730, China
West China Hospital, Sichuan University; Department of Breast
Chengdu, 610041, China
Sun Yat-sen Memorial Hospital
Guangzhou, 510000, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Cancer Hospital
Jinan, 250117, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029, China
Jiangsu Cancer Hospital
Nanjing, 211100, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Liaoning cancer Hospital & Institute
Shenyang, 110042, China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, 050035, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 3000060, China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, 710004, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
Ostrava-Poruba, 70852, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, 128 08, Czechia
Clinique Sainte Catherine; Hopital De Semaine
Avignon, 84918, France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Hopital Morvan
Brest, 29200, France
CHD Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Oscar Lambret; Senologie
Lille, 59020, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100, France
Hopital Caremeau; Hematologie Oncologie
Nîmes, 30029, France
Hopital Tenon
Paris, 75020, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Hopital Saint Louis, Service D Oncologie Medicale
Paris, 75475, France
Ch Pitie Salpetriere; Oncologie Medicale
Paris, 75651, France
Centre Eugene Marquis; Service d'oncologie
Rennes, 35042, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Institut Gustave Roussy; Sitep
Villejuif, 94805, France
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin, 13581, Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, 33604, Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, 50935, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, 45136, Germany
HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
Hamburg, 22767, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131, Germany
OnkoNet Marburg GmbH
Marburg, 35037, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153, Germany
Klinikum Ernst von Bergmann; Frauenklinik
Potsdam, 14467, Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, 53840, Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, 72076, Germany
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, 115 22, Greece
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
Athens, 115 28, Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, 145 64, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29, Greece
Yashoda Hospital
Hyderabad, Andhra Pradesh, 500082, India
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, 560017, India
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, 400012, India
Jehangir Hospital
Pune, Maharashtra, 411001, India
Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
New Delhi, National Capital Territory of Delhi, 110005, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076, India
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, 110085, India
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, National Capital Territory of Delhi, 110088, India
Apollo Speciality Hospital
Chennai, Tamil Nadu, 600035, India
Apollo Gleneagles Hospitals
Kolkata, West Bengal, 700054, India
TATA Medical Centre; Medical Oncology
Kolkata, West Bengal, 700156, India
MAX Balaji Hospital
Delhi, 1100092, India
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 9112000, Israel
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Rambam Health Corporation; Oncology Institute
Rambam, 3525408, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, 6423906, Israel
Assaf Harofeh; Oncology
Ẕerifin, 6093000, Israel
Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
Chieti, Abruzzo, 66103, Italy
Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
Frattamaggiore, Campania, 80027, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, 41110, Italy
Universita Campus Bio-Medico di Roma (UCBM)
Rome, Lazio, 00128, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Rome, Lazio, 00144, Italy
Azienda Policlinico Umberto I
Rome, Lazio, 00161, Italy
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, 16132, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, 24127, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123, Italy
Hospital San Raffaele
Milan, Lombardy, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
Milan, Lombardy, 20141, Italy
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano (MI), Lombardy, 20089, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, 10060, Italy
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicily, 98030, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Florence, Tuscany, 50134, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Tuscany, 57100, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padua, Veneto, 35128, Italy
Gunma Prefectural Cancer Center
Gunma, 373-8550, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Sagara Hospital
Kagoshima, 892-0833, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Naha-nishi Clinic
Okinawa, 901-0154, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakesh, 40000, Morocco
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
Rabat, 10000, Morocco
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, 200347, Romania
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, Moscow Oblast, 115478, Russia
Petrov Research Inst. of Oncology
Saint Petersburg, 197758, Russia
King Fahad Specialist Hospital; Oncology
Dammam, 31444, Saudi Arabia
International Medical Center (IMC)
Jeddah, 21451, Saudi Arabia
King Fahad Medical City; Gastroentrology
Riyadh, 11525, Saudi Arabia
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
Bratislava, 833 10, Slovakia
POKO Poprad; Department of Oncology
Poprad, 058 01, Slovakia
Wilgers Oncology Centre
Pretoria, 0001, South Africa
Private Oncology Centre
Pretoria, 0081, South Africa
Sandton Oncology Medical Group
Sandton, 2196, South Africa
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, 15006, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid, 28943, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013, Spain
Adana Baskent University Medical Faculty; Oncology
Adana, 01220, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06490, Turkey (Türkiye)
Uludag University Medical Faculty; Internal Medicine
Bursa, 16059, Turkey (Türkiye)
Dicle Uni Medical Faculty; Internal Medicine
Diyarbakır, 10000, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030, Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, 35965, Turkey (Türkiye)
Kocaeli University Faculty of Medicine; Medical oncology
İzmit, 31380, Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy, 34722, Turkey (Türkiye)
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT, United Kingdom
Christie Hospital
Manchester, M20 3BG, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
K hospital
Hanoi, 100000, Vietnam
Hochiminh city oncology hospital
Hochiminh City, 700000, Vietnam
Related Publications (1)
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.
PMID: 34219000DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The Sponsor and its agents; the study site personnel, including the investigator; and the participant will be blinded to treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 24, 2017
Study Start
August 25, 2017
Primary Completion
November 15, 2019
Study Completion
January 17, 2023
Last Updated
March 26, 2024
Results First Posted
January 7, 2021
Record last verified: 2024-03