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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)

Primary Purpose

Triple-Negative Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab Placebo
Paclitaxel
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-Negative Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer Center
  • Florida Cancer Specialists; Department of Oncology
  • Florida Cancer Specialist, North Region
  • Northwest Georgia Oncology Centers PC - Marietta
  • HCA Midwest Health
  • The Valley Hospital
  • Magee-Woman's Hospital
  • Tennessee Oncology; Sarah Cannon Research Institute
  • Centro Oncologico Riojano Integral (CORI)
  • Santa Casa de Misericordia de Salvador
  • Centro de Pesquisas Clinicas em Oncologia - CPCO
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Hospital Perola Byington
  • Tom Baker Cancer Centre-Calgary
  • Cross Cancer Institute
  • Kingston General Hospital
  • Grand River Hospital
  • London Regional Cancer Centre
  • Sunnybrook Odette Cancer Centre
  • McGill University; Glen Site; Oncology
  • Hopital du Saint Sacrement
  • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
  • Cancer Hospital Chinese Academy of Medical Sciences.
  • Beijing Union Hospital
  • West China Hospital, Sichuan University; Department of Breast
  • Sun Yat-sen Memorial Hospital
  • Harbin Medical University Cancer Hospital
  • Shandong Cancer Hospital
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  • Liaoning cancer Hospital & Institute
  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • Tianjin Medical University Cancer Institute & Hospital
  • The Second Affiliated Hospital of Xi'an Jiao Tong University
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Zhejiang Cancer Hospital
  • Henan Cancer Hospital
  • Clinical Hospital Centre Zagreb
  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  • Clinique Sainte Catherine; Hopital De Semaine
  • HOPITAL JEAN MINJOZ; Oncologie
  • Polyclinique Bordeaux Nord Aquitaine
  • Hopital Morvan
  • CHD Les Oudairies
  • Centre Oscar Lambret; Senologie
  • Centre Leon Berard; Departement Oncologie Medicale
  • Centre D'Oncologie de Gentilly; Oncology
  • Hopital Caremeau; Hematologie Oncologie
  • Hopital Tenon
  • Institut Curie; Oncologie Medicale
  • Hopital Saint Louis, Service D Oncologie Medicale
  • Ch Pitie Salpetriere; Oncologie Medicale
  • Centre Eugene Marquis; Service d'oncologie
  • Centre Paul Strauss; Oncologie Medicale
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Institut Gustave Roussy; Sitep
  • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
  • Onkologische Schwerpunktpraxis Bielefeld
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
  • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
  • OnkoNet Marburg GmbH
  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
  • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Klinikum Ernst von Bergmann; Frauenklinik
  • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
  • Universitätsklinik Tübingen; Frauenklinik
  • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
  • ARETAIEION UNIVERSITY HOSPITAL; oncology unit
  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
  • Papageorgiou General Hospital; Medical Oncology
  • Yashoda Hospital
  • Indraprastha Apollo Hospitals
  • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
  • Max Super Speciality Hospital; Medical Oncology
  • Manipal Hospital; Department of Oncology
  • Tata Memorial Hospital; Dept of Medical Oncology
  • Jehangir Hospital
  • TATA Medical Centre; Medical Oncology
  • Apollo Speciality Hospital
  • MAX Balaji Hospital
  • Apollo Gleneagles Hospitals
  • Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
  • Hadassah Ein Karem Hospital; Oncology Dept
  • Rabin MC; Davidof Center - Oncology Institute
  • Sheba Medical Center
  • Rambam Health Corporation; Oncology Institute
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Ctr; Oncology
  • Assaf Harofeh; Oncology
  • Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
  • Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
  • Azienda Ospedaliera Universitaria Federico II
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Azienda Ospedaliero - Universitaria di Modena Policlinico
  • Universita Campus Bio-Medico di Roma (UCBM)
  • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
  • Azienda Policlinico Umberto I
  • A.O. Universitaria S. Martino Di Genova
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
  • Asst Degli Spedali Civili Di Brescia
  • Hospital San Raffaele
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
  • IRCCS Istituto Clinico Humanitas; Oncologia
  • Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
  • Ospedale S. Vincenzo; Oncologia Medica
  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
  • Ospedale Civile; Unita Operativa Di Oncologia Medica
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Gunma Prefectural Cancer Center
  • Hiroshima City Hiroshima Citizens Hospital
  • Sagara Hospital
  • Kanagawa Cancer Center
  • Tokai University Hospital
  • Niigata Cancer Center Hospital
  • Naha-nishi Clinic
  • Osaka International Cancer Institute
  • Saitama Cancer Center
  • The Cancer Institute Hospital of JFCR
  • Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
  • Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
  • Prof. Dr. I. Chiricuta Institute of Oncology
  • Centrul de Oncologie Sfantul Nectarie
  • Petrov Research Inst. of Oncology
  • Russian Oncology Research Center n.a. N.N. Blokhin
  • King Fahad Specialist Hospital; Oncology
  • International Medical Center (IMC)
  • King Fahad Medical City; Gastroentrology
  • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
  • POKO Poprad; Department of Oncology
  • Wilgers Oncology Centre
  • Private Oncology Centre
  • Sandton Oncology Medical Group
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital Universitario de Fuenlabrada; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Adana Baskent University Medical Faculty; Oncology
  • Ankara Bilkent City Hospital
  • Uludag University Medical Faculty; Internal Medicine
  • Dicle Uni Medical Faculty; Internal Medicine
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Izmir Ataturk Training and Research Hospital
  • Kocaeli University Faculty of Medicine; Medical oncology
  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • Christie Hospital
  • Mount Vernon Cancer Centre
  • K hospital
  • Hochiminh city oncology hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo and Paclitaxel

Atezolizumab and Paclitaxel

Arm Description

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.

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.

Outcomes

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
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
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
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
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
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
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
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 )
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)
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 )
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 )
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)
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
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
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
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
Overall Survival by PD-L1 Status, Intent to Treat Population
Results from a pre-specified interim analysis.
Progression Free Survival by PD-L1 Status, Intent to Treat Population
Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population
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.

Full Information

First Posted
April 20, 2017
Last Updated
January 19, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03125902
Brief Title
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Acronym
IMpassion131
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-Negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The Sponsor and its agents; the study site personnel, including the investigator; and the participant will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo and Paclitaxel
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Atezolizumab and Paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Other Intervention Name(s)
MPDL3280A, TECENTRIQ
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab Placebo
Intervention Description
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Title
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
Description
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.
Time Frame
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in the PD-L1-Positive Subpopulation
Description
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Time Frame
From Day 1 to death from any cause, assessed up to primary completion date (approximately 26 months)
Title
Overall Survival (OS) in the ITT Population
Description
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Time Frame
From Day 1 to death from any cause, assessed up to primary completion date (approximately 26 months)
Title
Percentage of Participants Who Are Alive at 12 and 18 Months
Description
Results from a pre-specified interim analysis.
Time Frame
From Day 1 to death from any cause, assessed up to 12 and 18 months
Title
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
Description
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.
Time Frame
From Day 1 to deterioration, assessed up to primary completion date (approximately 26 months)
Title
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
Description
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.
Time Frame
From Day 1 to PD or death from any cause, assessed up to 12 months
Title
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )
Description
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.
Time Frame
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Title
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)
Description
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.
Time Frame
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Title
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )
Description
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.
Time Frame
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Title
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )
Description
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.
Time Frame
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Title
Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)
Description
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.
Time Frame
From objective response to PD, assessed up to primary completion date (approximately 26 months)
Title
Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
Description
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.
Time Frame
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Title
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).
Title
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population
Time Frame
C1D1 30 min postdose
Title
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
Time Frame
Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
Title
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)
Title
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Description
Investigator text for AEs is coded using MedDRA version 23.0
Time Frame
From Day 1 to 90 days after last dose of study drug, assessed up to primary completion date (approximately 26 months)
Title
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)
Title
Overall Survival by PD-L1 Status, Intent to Treat Population
Description
Results from a pre-specified interim analysis.
Time Frame
From Day 1 up to primary completion date (approximately 26 months)
Title
Progression Free Survival by PD-L1 Status, Intent to Treat Population
Time Frame
From Day 1 up to primary completion date (approximately 26 months)
Title
Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population
Description
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.
Time Frame
From objective response to PD, assessed up to primary completion date (approximately 26 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5820
Country
United States
Facility Name
Florida Cancer Specialists; Department of Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
HCA Midwest Health
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Magee-Woman's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Tennessee Oncology; Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Santa Casa de Misericordia de Salvador
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Centro de Pesquisas Clinicas em Oncologia - CPCO
City
Cachoeiro de Itapemirim
State/Province
ES
ZIP/Postal Code
29308-014
Country
Brazil
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Tom Baker Cancer Centre-Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University; Glen Site; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences.
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Union Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
West China Hospital, Sichuan University; Department of Breast
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Liaoning cancer Hospital & Institute
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
City
Shijiazhuang
ZIP/Postal Code
050035
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjing
ZIP/Postal Code
300060
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an City
ZIP/Postal Code
710004
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Clinique Sainte Catherine; Hopital De Semaine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
HOPITAL JEAN MINJOZ; Oncologie
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Hopital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHD Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Oscar Lambret; Senologie
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre D'Oncologie de Gentilly; Oncology
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Hopital Caremeau; Hematologie Oncologie
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Hopital Saint Louis, Service D Oncologie Medicale
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Ch Pitie Salpetriere; Oncologie Medicale
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Eugene Marquis; Service d'oncologie
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Paul Strauss; Oncologie Medicale
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy; Sitep
City
VILLEJUIF Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
City
Berlin
ZIP/Postal Code
13581
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
OnkoNet Marburg GmbH
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Klinikum Ernst von Bergmann; Frauenklinik
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
City
Troisdorf
ZIP/Postal Code
53840
Country
Germany
Facility Name
Universitätsklinik Tübingen; Frauenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
City
Kifisia
ZIP/Postal Code
145 64
Country
Greece
Facility Name
Papageorgiou General Hospital; Medical Oncology
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Facility Name
Yashoda Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Max Super Speciality Hospital; Medical Oncology
City
North WEST Delhi
State/Province
Delhi
ZIP/Postal Code
110088
Country
India
Facility Name
Manipal Hospital; Department of Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
Facility Name
Tata Memorial Hospital; Dept of Medical Oncology
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Jehangir Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
TATA Medical Centre; Medical Oncology
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700156
Country
India
Facility Name
Apollo Speciality Hospital
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
MAX Balaji Hospital
City
Delhi
ZIP/Postal Code
110092
Country
India
Facility Name
Apollo Gleneagles Hospitals
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
City
New Delhi
ZIP/Postal Code
110005
Country
India
Facility Name
Hadassah Ein Karem Hospital; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Facility Name
Rabin MC; Davidof Center - Oncology Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Rambam Health Corporation; Oncology Institute
City
Rambam
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Ctr; Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh; Oncology
City
Zerifin
ZIP/Postal Code
6093000
Country
Israel
Facility Name
Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66103
Country
Italy
Facility Name
Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
City
Frattamaggiore
State/Province
Campania
ZIP/Postal Code
80027
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria di Modena Policlinico
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41110
Country
Italy
Facility Name
Universita Campus Bio-Medico di Roma (UCBM)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O. Universitaria S. Martino Di Genova
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Asst Degli Spedali Civili Di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Hospital San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas; Oncologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale S. Vincenzo; Oncologia Medica
City
Taormina
State/Province
Sicilia
ZIP/Postal Code
98030
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale Civile; Unita Operativa Di Oncologia Medica
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57100
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Gunma Prefectural Cancer Center
City
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Sagara Hospital
City
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Naha-nishi Clinic
City
Okinawa
ZIP/Postal Code
901-0154
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
City
Rabat
ZIP/Postal Code
10000
Country
Morocco
Facility Name
Prof. Dr. I. Chiricuta Institute of Oncology
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Centrul de Oncologie Sfantul Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Petrov Research Inst. of Oncology
City
Pesochny
State/Province
Leningrad
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. N.N. Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
King Fahad Specialist Hospital; Oncology
City
Dammam
ZIP/Postal Code
31444
Country
Saudi Arabia
Facility Name
International Medical Center (IMC)
City
Jeddah
ZIP/Postal Code
21451
Country
Saudi Arabia
Facility Name
King Fahad Medical City; Gastroentrology
City
Riyadh
ZIP/Postal Code
11525
Country
Saudi Arabia
Facility Name
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
POKO Poprad; Department of Oncology
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Wilgers Oncology Centre
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Private Oncology Centre
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Sandton Oncology Medical Group
City
Sandton
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28943
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Adana Baskent University Medical Faculty; Oncology
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Uludag University Medical Faculty; Internal Medicine
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Dicle Uni Medical Faculty; Internal Medicine
City
Diyarbakir
ZIP/Postal Code
10000
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Izmir Ataturk Training and Research Hospital
City
Izmir
ZIP/Postal Code
35965
Country
Turkey
Facility Name
Kocaeli University Faculty of Medicine; Medical oncology
City
Izmit
ZIP/Postal Code
31380
Country
Turkey
Facility Name
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 3BG
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
K hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Hochiminh city oncology hospital
City
Hochiminh city
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
34219000
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.
Results Reference
derived
Links:
URL
https://www.pioneeringhealthcare.com/de/trials/breast-cancer-de/178/impassion131-de/
Description
Additional information for the IMpassion131
URL
https://www.wissen-immuntherapie.de/klinische-studien/studien-finden/
Description
general information on clinical trials

Learn more about this trial

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

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