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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03125902

Recruitment Status : Active, not recruiting

First Posted : April 24, 2017

Results First Posted : January 7, 2021

Last Update Posted : May 16, 2022

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Triple-Negative Breast Cancer	Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug: Atezolizumab Placebo Drug: Paclitaxel	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	651 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Masking Description:	The Sponsor and its agents; the study site personnel, including the investigator; and the participant will be blinded to treatment assignment.
Primary Purpose:	Treatment
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
Actual Study Start Date :	August 25, 2017
Actual Primary Completion Date :	November 15, 2019
Estimated Study Completion Date :	June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Paclitaxel Atezolizumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Drug: 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. Other Name: MPDL3280A, TECENTRIQ Drug: 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.
Experimental: 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.	Drug: Atezolizumab Placebo Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle. Drug: 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.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) ]
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.
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 [ Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) ]
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.

Secondary Outcome Measures :

Overall Survival (OS) in the PD-L1-Positive Subpopulation [ Time Frame: From Day 1 to death from any cause, assessed up to primary completion date (approximately 26 months) ]
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Overall Survival (OS) in the ITT Population [ Time Frame: From Day 1 to death from any cause, assessed up to primary completion date (approximately 26 months) ]
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Percentage of Participants Who Are Alive at 12 and 18 Months [ Time Frame: From Day 1 to death from any cause, assessed up to 12 and 18 months ]
Results from a pre-specified interim analysis.
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population [ Time Frame: From Day 1 to deterioration, assessed up to primary completion date (approximately 26 months) ]
Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1 [ Time Frame: From Day 1 to PD or death from any cause, assessed up to 12 months ]
PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed ) [ Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months) ]
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed) [ Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months) ]
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD.
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed ) [ Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months) ]
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed ) [ Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months) ]
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD.
Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed) [ Time Frame: From objective response to PD, assessed up to primary completion date (approximately 26 months) ]
DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population [ Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months) ]
Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population [ Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months). ]
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population [ Time Frame: C1D1 30 min postdose ]
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel [ Time Frame: Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days) ]
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel [ Time Frame: 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) ]
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: From Day 1 to 90 days after last dose of study drug, assessed up to primary completion date (approximately 26 months) ]
Investigator text for AEs is coded using MedDRA version 23.0
Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population [ Time Frame: 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) ]
Overall Survival by PD-L1 Status, Intent to Treat Population [ Time Frame: From Day 1 up to primary completion date (approximately 26 months) ]
Results from a pre-specified interim analysis.
Progression Free Survival by PD-L1 Status, Intent to Treat Population [ Time Frame: From Day 1 up to primary completion date (approximately 26 months) ]
Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population [ Time Frame: From objective response to PD, assessed up to primary completion date (approximately 26 months) ]
C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125902

Locations

Show 161 study locations

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United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5820
United States, Florida
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States, 33901-8101
Florida Cancer Specialist, North Region
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States, 30060
United States, Missouri
HCA Midwest Health
Kansas City, Missouri, United States, 64132
United States, New Jersey
The Valley Hospital
Paramus, New Jersey, United States, 07652
United States, Pennsylvania
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Tennessee Oncology; Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300COE
Brazil
Santa Casa de Misericordia de Salvador
Salvador, BA, Brazil, 40050-410
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim, ES, Brazil, 29308-014
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania, GO, Brazil, 74605-070
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Grand River Hospital
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University; Glen Site; Oncology
Montreal, Quebec, Canada, H4A 3J1
Hopital du Saint Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China, 100021
Beijing Union Hospital
Beijing, China, 100730
West China Hospital, Sichuan University; Department of Breast
Chengdu, China, 610041
Sun Yat-sen Memorial Hospital
Guangzhou, China, 510000
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Shandong Cancer Hospital
Jinan, China, 250117
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing City, China, 210029
Jiangsu Cancer Hospital
Nanjing City, China, 211100
Fudan University Shanghai Cancer Center
Shanghai City, China, 200120
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, China, 200025
Liaoning cancer Hospital & Institute
Shenyang, China, 110042
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, China, 050035
Tianjin Medical University Cancer Institute & Hospital
Tianjing, China, 300060
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an City, China, 710004
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China, 710061
Zhejiang Cancer Hospital
Zhejiang, China, 310022
Henan Cancer Hospital
Zhengzhou, China, 450008
Croatia
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
Ostrava-Poruba, Czechia, 70852
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2, Czechia, 128 08
France
Clinique Sainte Catherine; Hopital De Semaine
Avignon, France, 84918
HOPITAL JEAN MINJOZ; Oncologie
Besancon, France, 25030
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Hopital Morvan
Brest, France, 29200
CHD Les Oudairies
La Roche Sur Yon, France, 85925
Centre Oscar Lambret; Senologie
Lille, France, 59020
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
Hopital Caremeau; Hematologie Oncologie
Nimes, France, 30029
Hopital Tenon
Paris, France, 75020
Institut Curie; Oncologie Medicale
Paris, France, 75231
Hopital Saint Louis, Service D Oncologie Medicale
Paris, France, 75475
Ch Pitie Salpetriere; Oncologie Medicale
Paris, France, 75651
Centre Eugene Marquis; Service d'oncologie
Rennes, France, 35042
Centre Paul Strauss; Oncologie Medicale
Strasbourg, France, 67065
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Institut Gustave Roussy; Sitep
VILLEJUIF Cedex, France, 94805
Germany
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin, Germany, 13581
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany, 33604
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, Germany, 45136
HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
Hamburg, Germany, 22767
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, Germany, 69120
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Koeln, Germany, 50935
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, Germany, 55131
OnkoNet Marburg GmbH
Marburg, Germany, 35037
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, Germany, 80337
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, Germany, 48153
Klinikum Ernst von Bergmann; Frauenklinik
Potsdam, Germany, 14467
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, Germany, 53840
Universitätsklinik Tübingen; Frauenklinik
Tübingen, Germany, 72076
Greece
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, Greece, 115 22
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
Athens, Greece, 115 28
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifisia, Greece, 145 64
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, Greece, 564 29
India
Yashoda Hospital
Hyderabad, Andhra Pradesh, India, 500082
Indraprastha Apollo Hospitals
New Delhi, Delhi, India, 110076
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, Delhi, India, 110085
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, Delhi, India, 110088
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, India, 560017
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, India, 400012
Jehangir Hospital
Pune, Maharashtra, India, 411001
TATA Medical Centre; Medical Oncology
Kolkata, WEST Bengal, India, 700156
Apollo Speciality Hospital
Chennai, India, 600035
MAX Balaji Hospital
Delhi, India, 110092
Apollo Gleneagles Hospitals
Kolkata, India, 700054
Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
New Delhi, India, 110005
Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 9112000
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva, Israel, 4941492
Sheba Medical Center
Ramat Gan, Israel, 5262100
Rambam Health Corporation; Oncology Institute
Rambam, Israel, 3525408
Kaplan Medical Center
Rehovot, Israel, 7610001
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, Israel, 6423906
Assaf Harofeh; Oncology
Zerifin, Israel, 6093000
Italy
Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
Chieti, Abruzzo, Italy, 66103
Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
Frattamaggiore, Campania, Italy, 80027
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy, 80131
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy, 80131
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, Italy, 41110
Universita Campus Bio-Medico di Roma (UCBM)
Roma, Lazio, Italy, 00128
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Roma, Lazio, Italy, 00144
Azienda Policlinico Umberto I
Roma, Lazio, Italy, 00161
A.O. Universitaria S. Martino Di Genova
Genova, Liguria, Italy, 16132
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardia, Italy, 24127
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardia, Italy, 25123
Hospital San Raffaele
Milano, Lombardia, Italy, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Lombardia, Italy, 20133
IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
Milano, Lombardia, Italy, 20141
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano, Lombardia, Italy, 20089
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piemonte, Italy, 10060
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicilia, Italy, 98030
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Firenze, Toscana, Italy, 50134
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Toscana, Italy, 57100
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, Veneto, Italy, 35128
Japan
Gunma Prefectural Cancer Center
Gunma, Japan, 373-8550
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Sagara Hospital
Kagoshima, Japan, 892-0833
Kanagawa Cancer Center
Kanagawa, Japan, 241-8515
Tokai University Hospital
Kanagawa, Japan, 259-1193
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Naha-nishi Clinic
Okinawa, Japan, 901-0154
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Saitama Cancer Center
Saitama, Japan, 362-0806
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Morocco
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakech, Morocco, 40000
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
Rabat, Morocco, 10000
Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Centrul de Oncologie Sfantul Nectarie
Craiova, Romania, 200347
Russian Federation
Petrov Research Inst. of Oncology
Pesochny, Leningrad, Russian Federation, 197758
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, Russian Federation, 115478
Saudi Arabia
King Fahad Specialist Hospital; Oncology
Dammam, Saudi Arabia, 31444
International Medical Center (IMC)
Jeddah, Saudi Arabia, 21451
King Fahad Medical City; Gastroentrology
Riyadh, Saudi Arabia, 11525
Slovakia
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
Bratislava, Slovakia, 833 10
POKO Poprad; Department of Oncology
Poprad, Slovakia, 058 01
South Africa
Wilgers Oncology Centre
Pretoria, South Africa, 0001
Private Oncology Centre
Pretoria, South Africa, 0081
Sandton Oncology Medical Group
Sandton, South Africa, 2196
Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, Spain, 15006
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid, Spain, 28943
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Turkey
Adana Baskent University Medical Faculty; Oncology
Adana, Turkey, 01220
Ankara City Hospital
Ankara, Turkey, 06490
Uludag University Medical Faculty; Internal Medicine
Bursa, Turkey, 16059
Dicle Uni Medical Faculty; Internal Medicine
Diyarbakir, Turkey, 10000
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, Turkey, 22030
Izmir Ataturk Training and Research Hospital
Izmir, Turkey, 35965
Kocaeli University Faculty of Medicine; Medical oncology
Izmit, Turkey, 31380
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy, Turkey, 34722
United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, United Kingdom, SE1 9RT
Christie Hospital
Manchester, United Kingdom, M20 3BG
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Vietnam
K hospital
Hanoi, Vietnam, 100000
Hochiminh city oncology hospital
Hochiminh city, Vietnam, 700000

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

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Study Director:	Clinical Trials	Hoffmann-La Roche

Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol [PDF] February 11, 2020

Statistical Analysis Plan [PDF] March 25, 2020

More Information

Additional Information:

Additional information for the IMpassion131 This link exits the ClinicalTrials.gov site

general information on clinical trials This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Miles D, Gligorov J, André 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.

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Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT03125902
Other Study ID Numbers:	MO39196 2016-004024-29 ( EudraCT Number )
First Posted:	April 24, 2017 Key Record Dates
Results First Posted:	January 7, 2021
Last Update Posted:	May 16, 2022
Last Verified:	May 2022

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Atezolizumab Antibodies	Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs

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