Clinical trial NCT03125902: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Triple-Negative Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 653
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
measure: 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
timeFrame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Secondary outcomes:
measure: Overall Survival (OS) in the PD-L1-Positive Subpopulation
timeFrame: From Day 1 to death from any cause, assessed up 36 months
measure: Overall Survival (OS) in the ITT Population
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
measure: Percentage of Participants Who Are Alive at 12 and 18 Months
timeFrame: From Day 1 to death from any cause, assessed up to 12 and 18 months
measure: Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
timeFrame: From Day 1 to deterioration, assessed up 64 months
measure: Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
timeFrame: From Day 1 to PD or death from any cause, assessed up to 12 months
measure: Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )
timeFrame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
measure: Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)
timeFrame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
measure: Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )
timeFrame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
measure: Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )
timeFrame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
measure: Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)
timeFrame: From objective response to PD, assessed up to primary completion date (approximately 26 months)
measure: Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
timeFrame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
measure: Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
timeFrame: Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).
measure: Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population
timeFrame: C1D1 30 min postdose
measure: Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
timeFrame: Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
measure: Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
timeFrame: Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: From Day 1 From baseline up to 64 months
measure: Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
timeFrame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)
measure: Overall Survival by PD-L1 Status, Intent to Treat Population
timeFrame: From Day 1 up to 66 months
measure: Progression Free Survival by PD-L1 Status, Intent to Treat Population
timeFrame: From Day 1 up to primary completion date (approximately 26 months)
measure: Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population
timeFrame: From objective response to PD, assessed up to primary completion date (approximately 26 months)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists; Department of Oncology
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist, North Region
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC - Marietta
state: Georgia
city: Kansas City
country: United States
facility: HCA Midwest Health
state: Missouri
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Pittsburgh
country: United States
facility: Magee-Woman's Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology; Sarah Cannon Research Institute
state: Tennessee
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Salvador
country: Brazil
facility: Santa Casa de Misericordia de Salvador
state: BA
city: Cachoeiro de Itapemirim
country: Brazil
facility: Centro de Pesquisas Clinicas em Oncologia - CPCO
state: ES
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama
state: GO
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Glen Site; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Beijing Union Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University; Department of Breast
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
city: Shenyang
country: China
facility: Liaoning cancer Hospital & Institute
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Xi'an City
country: China
facility: The Second Affiliated Hospital of Xi'an Jiao Tong University
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Avignon
country: France
facility: Clinique Sainte Catherine; Hopital De Semaine
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brest
country: France
facility: Hopital Morvan
city: La Roche Sur Yon
country: France
facility: CHD Les Oudairies
city: Lille
country: France
facility: Centre Oscar Lambret; Senologie
city: Lyon
country: France
facility: Centre Leon Berard; Departement Oncologie Medicale
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Nimes
country: France
facility: Hopital Caremeau; Hematologie Oncologie
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: Hopital Saint Louis, Service D Oncologie Medicale
city: Paris
country: France
facility: Ch Pitie Salpetriere; Oncologie Medicale
city: Rennes
country: France
facility: Centre Eugene Marquis; Service d'oncologie
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: VILLEJUIF Cedex
country: France
facility: Institut Gustave Roussy; Sitep
city: Berlin
country: Germany
facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
city: Bielefeld
country: Germany
facility: Onkologische Schwerpunktpraxis Bielefeld
city: Essen
country: Germany
facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
city: Hamburg
country: Germany
facility: HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
city: Koeln
country: Germany
facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
city: Marburg
country: Germany
facility: OnkoNet Marburg GmbH
city: München
country: Germany
facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann; Frauenklinik
city: Troisdorf
country: Germany
facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen; Frauenklinik
city: Athens
country: Greece
facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
city: Athens
country: Greece
facility: ARETAIEION UNIVERSITY HOSPITAL; oncology unit
city: Kifisia
country: Greece
facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital; Medical Oncology
city: Hyderabad
country: India
facility: Yashoda Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
state: Delhi
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
state: Delhi
city: North WEST Delhi
country: India
facility: Max Super Speciality Hospital; Medical Oncology
state: Delhi
city: Bangalore
country: India
facility: Manipal Hospital; Department of Oncology
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital; Dept of Medical Oncology
state: Maharashtra
city: Pune
country: India
facility: Jehangir Hospital
state: Maharashtra
city: Chennai
country: India
facility: Apollo Speciality Hospital
state: Tamil NADU
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals
state: WEST Bengal
city: Kolkata
country: India
facility: TATA Medical Centre; Medical Oncology
state: WEST Bengal
city: Delhi
country: India
facility: MAX Balaji Hospital
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Oncology Dept
city: Petach Tikva
country: Israel
facility: Rabin MC; Davidof Center - Oncology Institute
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rambam
country: Israel
facility: Rambam Health Corporation; Oncology Institute
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Ctr; Oncology
city: Zerifin
country: Israel
facility: Assaf Harofeh; Oncology
city: Chieti
country: Italy
facility: Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
state: Abruzzo
city: Frattamaggiore
country: Italy
facility: Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria di Modena Policlinico
state: Emilia-Romagna
city: Roma
country: Italy
facility: Universita Campus Bio-Medico di Roma (UCBM)
state: Lazio
city: Roma
country: Italy
facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
state: Lazio
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
state: Lazio
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova
state: Liguria
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
state: Lombardia
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Hospital San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: IRCCS Istituto Clinico Humanitas; Oncologia
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
state: Piemonte
city: Taormina
country: Italy
facility: Ospedale S. Vincenzo; Oncologia Medica
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
state: Toscana
city: Livorno
country: Italy
facility: Ospedale Civile; Unita Operativa Di Oncologia Medica
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
state: Veneto
city: Gunma
country: Japan
facility: Gunma Prefectural Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okinawa
country: Japan
facility: Naha-nishi Clinic
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Marrakech
country: Morocco
facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
city: Rabat
country: Morocco
facility: Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. N.N. Blokhin
state: Moskovskaja Oblast
city: Sankt Petersburg
country: Russian Federation
facility: Petrov Research Inst. of Oncology
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital; Oncology
city: Jeddah
country: Saudi Arabia
facility: International Medical Center (IMC)
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City; Gastroentrology
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
city: Poprad
country: Slovakia
facility: POKO Poprad; Department of Oncology
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Pretoria
country: South Africa
facility: Private Oncology Centre
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
state: LA Coruña
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Adana
country: Turkey
facility: Adana Baskent University Medical Faculty; Oncology
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty; Internal Medicine
city: Diyarbakir
country: Turkey
facility: Dicle Uni Medical Faculty; Internal Medicine
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Izmir
country: Turkey
facility: Izmir Ataturk Training and Research Hospital
city: Izmit
country: Turkey
facility: Kocaeli University Faculty of Medicine; Medical oncology
city: Kadiköy
country: Turkey
facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Hanoi
country: Vietnam
facility: K hospital
city: Hochiminh city
country: Vietnam
facility: Hochiminh city oncology hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.