Back to resultsA Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
Primary Purpose
Triple Negative Breast Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Nab-Paclitaxel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
- A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end-organ function
Exclusion Criteria:
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Pregnancy or lactation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplantation
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo
Sites / Locations
- University of Alabama at Birmingham
- Highlands Oncology Group
- Kaiser Permanente of Northern California
- Emad Ibrahim, Md, Inc
- Univ of Calif, San Francisco; Breast Cancer Center
- Kaiser Permanente - San Marcos
- Cancer Research Collaboration, Inc.
- Stanford Univ School of Med; Oncology
- Kaiser Permanente Of Colorado
- Yale Cancer Center; Medical Oncology
- Norwalk Hospital
- Stamford Hospital; BCC, MOHR
- MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
- Florida Cancer Specialists - SCRI; Pharmacy
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
- The Mount Siani Comprehensive Cancer Center
- Florida Cancer Research Institute
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
- Northwest Georgia Oncology Centers PC - Marietta
- Rush University Medical Center - Chicago
- Mercy Medical Center
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Maryland Oncology Hematology
- Barbara Ann Karmanos Cancer Institute; Oncology
- West Michigan Cancer Center
- Jackson Oncology Associates, PLLC
- Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
- Washington University School of Medicine
- New Hampshire Hematology Oncology
- The Valley Hospital
- Montefiore Medical Center
- ProHEALTH Care Associates LLP
- Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
- Onc/Hem Care Clin Trials LLC
- The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
- Kaiser Perm NW - Rheuma
- Providence Cancer Center
- St. Luke's Cancer Care Associates
- Magee Womens Hospital
- Greenville Health System (GHS) Cancer Institute
- Wellmont Bristol Regional Medical Center
- West Clinic
- Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
- Vanderbilt
- Texas Oncology- El Paso Cancer Treatment Center Gateway
- The Methodist Cancer Center
- University of Texas;M.D. Anderson Cancer Center
- Inova Medical Group
- Cancer Care Northwest
- Centro de Oncologia e Investigacion Buenos Aires (COIBA)
- Fundación CENIT para la Investigación en Neurociencias
- Centro Oncologico Riojano Integral (CORI)
- Chris O'Brien Lifehouse
- Nepean Cancer Care Centre
- Icon Cancer Foundation
- Princess Alexandra Hospital; Division of Cancer Services
- Peninsula and South Eastern Haematology and Oncology Group
- Peter MacCallum Cancer Centre; Medical Oncology
- Sunshine Hospital
- St John of God Hospital; Bendat Cancer Centre
- Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
- Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
- A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
- Institut Jules Bordet
- Cliniques Universitaires St-Luc
- GHdC Site Notre Dame
- AZ Groeninge
- UZ Leuven Gasthuisberg
- Sint Augustinus Wilrijk
- Clinic of Oncology, University Clinical Center Sarajevo
- Santa Casa de Misericordia de Salvador
- Crio - Centro Regional Integrado de Oncologia
- Hospital Araujo Jorge; Departamento de Ginecologia E Mama
- Hospital de Caridade de Ijui; Oncologia
- Hospital das Clinicas - UFRGS
- Hospital Sao Lucas - PUCRS
- Centro de Pesquisas Oncologicas - CEPON
- Clinica de Neoplasias Litoral
- Hospital Perola Byington
- Hospital Sao Jose
- Tom Baker Cancer Centre-Calgary
- Cross Cancer Institute ; Dept of Medical Oncology
- BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
- British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
- Queen Elizabeth II Health Sciences Centre; Oncology
- Kingston General Hospital
- Lakeridge Health Oshawa; Oncology
- The Ottawa Hospital Cancer Centre
- Sunnybrook Odette Cancer Centre
- Jewish General Hospital
- Hopital du Saint Sacrement
- Centro de Cancer Pontificie Universidad Catolica de Chile
- Sociedad de Investigaciones Medicas Ltda (SIM)
- Clinica del Country
- Oncomedica S.A.
- Clinica CIMCA
- ICIMED Instituto de Investigación en Ciencias Médicas
- Fakultni nemocnice Olomouc; Onkologicka klinika
- Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
- Fakultni nemocnice v Motole
- North Estonia Medical Centre Foundation; Oncology Centre
- Tartu Uni Hospital; Hematology - Oncology Clinic
- Tampere University Hospital; Dept of Oncology
- Ico - Paul Papin
- Institut Sainte Catherine
- Hopital Jean Minjoz
- HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale
- Centre Oscar Lambret
- Centre Leon Berard
- Institut régional du Cancer Montpellier
- Clinique Catherine de Sienne
- Institut Curie
- Hopital La Pitie Salpetriere
- Institut De Cancerologie De L'Ouest; Medical Oncology
- Centre Paul Strauss
- Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
- St. Johannes Hospital; Abt. für Hämatologie und Onkologie
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
- Universitätsklinikum Erlangen; Frauenklinik
- Uniklinik Essen; Gynäkologie
- Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
- Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
- Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
- Facharztzentrum Eppendorf, Studien GbR
- Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
- Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
- St. Elisabeth-Krankenhaus; Brustzentrum
- Universitätsklinikum Schleswig-Holstein; Campus Lübeck
- Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
- Gemeinschaftspraxis für Hämatologie und Onkologie
- MVZ Nordhausen gGmbH, Praxis Dr. Grafe
- Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
- Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie
- Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
- Universitätsklinik Tübingen; Frauenklinik & Poliklinik
- Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
- IASO General Hospital of Athens
- Univ General Hosp Heraklion; Medical Oncology
- University Hospital of Patras Medical Oncology
- Euromedical General Clinic of Thessaloniki; Oncology Department
- Grupo Angeles
- Queen Mary Hospital; Dept of Medicine
- Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
- Fövárosi Önkormányzat uzsoki utcai Kórház
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
- Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
- Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
- Aichi Cancer Center Hospital
- Fukushima Medical University Hospital
- Gunma Prefectural Cancer Center
- Hiroshima City Hiroshima Citizens Hospital
- Hiroshima University Hospital
- National Hospital Organization Hokkaido Cancer Center
- Hyogo Medical University Hospital
- Sagara Hospital
- St. Marianna University Hospital
- Tokai University Hospital
- Kumamoto University Hospital
- Kyoto University Hospital
- Mie University Hospital
- Tohoku University Hospital
- Niigata Cancer Center Hospital
- Okayama University Hospital
- Naha-nishi Clinic
- National Hospital Organization Osaka National Hospital
- Osaka International Cancer Institute
- Kindai University Hospital
- Saitama Medical University International Medical Center
- Saitama Cancer Center
- Shizuoka Cancer Center
- National Cancer Center Hospital
- St. Luke's International Hospital
- Komagome Hospital
- The Cancer Institute Hospital of JFCR
- National Cancer Center
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- Daugavpils Regional Hospital
- Riga East Clinical University Hospital Latvian Oncology Centre
- Centro Medico Dalinde
- Centro Médico Zambrano Hellion
- Instituto Estatal de Cancerologia Colima
- Iem-Fucam
- Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
- Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk
- Sørlandet Sykehus Kristiansand
- Stavanger Universitetssykehus, Helse Stavanger HF
- Centro Oncológico de Panamá
- Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
- Szpitale Wojewodzkie w Gdyni Sp. z o.o.
- Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
- Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
- Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
- Wojskowy Instytut Medyczny
- Oncomed SRL
- Arkhangelsk Regional Clinical Oncology Dispensary
- Moscow City Oncology Hospital #62
- Main Military Clinical Hospital named after N.N. Burdenko
- Blokhin Cancer Research Center; Combined Treatment
- Ivanovo Regional Oncology Dispensary
- Clinical Oncology Dispensary of Ministry of Health of Tatarstan
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
- National University Hospital
- National Cancer Centre
- Institute of Oncology Ljubljana
- Hospital Universitario Reina Sofia; Servicio de Oncologia
- Hospital del Mar; Servicio de Oncologia
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital Duran i Reynals; Oncologia
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Hospital Universitario La Paz; Servicio de Oncologia
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
- Instituto Valenciano Oncologia; Oncologia Medica
- Sodersjukhuset; Onkologkliniken
- Akademiska sjukhuset, Onkologkliniken
- Universitaetsspital Basel; Onkologie
- Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum
- Universitätsspital Zürich
- Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
- China Medical University Hospital; Surgery
- VETERANS GENERAL HOSPITAL; Department of General Surgery
- National Taiwan Uni Hospital; General Surgery
- Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
- Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
- Songklanagarind Hospital; Department of Oncology
- Cukurova Uni Faculty of Medicine; Medical Oncology
- Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department
- Medipol University MF; Oncology Department
- Ege Uni Medical Faculty Hospital; Oncology Dept
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
- Chemotherapy SI Dnipropetrovsk MA of MOHU
- Kyiv City Clinical Oncological Center
- Treatment and Prevention Institution Volyn Regional Oncology Dispensary
- Lviv State Oncology Regional Treatment and Diagnostic Centre
- Velindre Cancer Centre
- Western General Hospital; Clinical Oncology
- St Bartholomew's Hospital
- Guys ST Thomas Hospital
- Royal Marsden Hospital - London
- Christie Hospital Nhs Trust; Medical Oncology
- Derriford Hospital
- Royal Preston Hosptial
- Weston Park Hospital
- Royal Marsden Hospital; Dept of Medical Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atezolizumab Plus Nab-Paclitaxel
Placebo Plus Nab-Paclitaxel
Arm Description
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
Overall Survival (OS) in All Randomized Participants
OS was defined as the time from the date of randomization to the date of death from any cause.
OS in Participants With Detectable PD-L1
OS was defined as the time from the date of randomization to the date of death from any cause.
Secondary Outcome Measures
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
Percentage of Participants With at Least One Adverse Event
Percentage of participants with at least one adverse event.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Maximum Serum Concentration (Cmax) for Atezolizumab
Maximum serum concentration for atezolizumab.
Minimum Serum Concentration (Cmin) for Atezolizumab
Minimum serum concentration for atezolizumab.
Plasma Concentrations of Total Paclitaxel
Plasma Concentrations of Total Paclitaxel
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02425891
Brief Title
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
Official Title
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2015 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.
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
Allocation
Randomized
Enrollment
902 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atezolizumab Plus Nab-Paclitaxel
Arm Type
Experimental
Arm Description
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Arm Title
Placebo Plus Nab-Paclitaxel
Arm Type
Placebo Comparator
Arm Description
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Other Intervention Name(s)
Tecentriq, MPDL3280A
Intervention Description
Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Other Intervention Name(s)
Abraxane®
Intervention Description
Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants
Description
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
Time Frame
Baseline up to approximately 34 months
Title
PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
Description
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
Time Frame
Baseline up to approximately 34 months
Title
Overall Survival (OS) in All Randomized Participants
Description
OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Baseline until death due to any cause (up to approximately 58 months)
Title
OS in Participants With Detectable PD-L1
Description
OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Baseline until death due to any cause (up to approximately 58 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
Description
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
Time Frame
Baseline up to approximately 34 months
Title
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
Description
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
Time Frame
Baseline up to approximately 34 months
Title
Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
Description
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
Time Frame
Baseline up to approximately 34 months
Title
DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
Description
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
Time Frame
Baseline up to approximately 34 months
Title
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
Description
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
Time Frame
Baseline up to approximately 58 months
Title
TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
Description
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
Time Frame
Baseline up to approximately 58 months
Title
Percentage of Participants With at Least One Adverse Event
Description
Percentage of participants with at least one adverse event.
Time Frame
Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Description
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Time Frame
Baseline up to approximately 53 months
Title
Maximum Serum Concentration (Cmax) for Atezolizumab
Description
Maximum serum concentration for atezolizumab.
Time Frame
Cycle 1 Day 1 (Cycle = 28 days)
Title
Minimum Serum Concentration (Cmin) for Atezolizumab
Description
Minimum serum concentration for atezolizumab.
Time Frame
Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
Title
Plasma Concentrations of Total Paclitaxel
Description
Plasma Concentrations of Total Paclitaxel
Time Frame
Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end-organ function
Exclusion Criteria:
Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
Leptomeningeal disease
Pregnancy or lactation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
Positive test for human immunodeficiency virus
Active hepatitis B or hepatitis C
Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo
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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Kaiser Permanente of Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Emad Ibrahim, Md, Inc
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Univ of Calif, San Francisco; Breast Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente - San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
Cancer Research Collaboration, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Stanford Univ School of Med; Oncology
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5821
Country
United States
Facility Name
Kaiser Permanente Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Yale Cancer Center; Medical Oncology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Stamford Hospital; BCC, MOHR
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists - SCRI; Pharmacy
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
The Mount Siani Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Cancer Research Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
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
Rush University Medical Center - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Maryland Oncology Hematology
City
Rochville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute; Oncology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New Hampshire Hematology Oncology
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
ProHEALTH Care Associates LLP
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Onc/Hem Care Clin Trials LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Kaiser Perm NW - Rheuma
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97231
Country
United States
Facility Name
St. Luke's Cancer Care Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Greenville Health System (GHS) Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Wellmont Bristol Regional Medical Center
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
West Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology- El Paso Cancer Treatment Center Gateway
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
The Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas;M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Medical Group
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires (COIBA)
City
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Nepean Cancer Care Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Icon Cancer Foundation
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital; Division of Cancer Services
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Peter MacCallum Cancer Centre; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
St John of God Hospital; Bendat Cancer Centre
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Institut Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Clinic of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
7100
Country
Bosnia and Herzegovina
Facility Name
Santa Casa de Misericordia de Salvador
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Crio - Centro Regional Integrado de Oncologia
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60336-550
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 de Caridade de Ijui; Oncologia
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Centro de Pesquisas Oncologicas - CEPON
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral
City
Itajai
State/Province
SC
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Hospital Sao Jose
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01321-001
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 ; Dept of Medical Oncology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Oncology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2H 6C2
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Centro de Cancer Pontificie Universidad Catolica de Chile
City
Santiago
ZIP/Postal Code
8330074
Country
Chile
Facility Name
Sociedad de Investigaciones Medicas Ltda (SIM)
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Clinica del Country
City
Bogota
ZIP/Postal Code
11001
Country
Colombia
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San José
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
North Estonia Medical Centre Foundation; Oncology Centre
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu Uni Hospital; Hematology - Oncology Clinic
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Tampere University Hospital; Dept of Oncology
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Ico - Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Clinique Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Institut De Cancerologie De L'Ouest; Medical Oncology
City
Saint Herblain
ZIP/Postal Code
44115
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
City
Berlin
ZIP/Postal Code
13581
Country
Germany
Facility Name
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen; Frauenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Uniklinik Essen; Gynäkologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
City
Georgsmarienhütte
ZIP/Postal Code
49124
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Facharztzentrum Eppendorf, Studien GbR
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
St. Elisabeth-Krankenhaus; Brustzentrum
City
Köln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
MVZ Nordhausen gGmbH, Praxis Dr. Grafe
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
Facility Name
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie
City
Trier
ZIP/Postal Code
54290
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 & Poliklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
IASO General Hospital of Athens
City
Athens
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University Hospital of Patras Medical Oncology
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546450
Country
Greece
Facility Name
Grupo Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Queen Mary Hospital; Dept of Medicine
City
Hong Kong
Country
Hong Kong
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Fövárosi Önkormányzat uzsoki utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
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
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Medical University Hospital
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Sagara Hospital
City
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
St. Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Mie University Hospital
City
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Naha-nishi Clinic
City
Okinawa
ZIP/Postal Code
901-0154
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Riga East Clinical University Hospital Latvian Oncology Centre
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Centro Medico Dalinde
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Centro Médico Zambrano Hellion
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Instituto Estatal de Cancerologia Colima
City
Colima
ZIP/Postal Code
28000
Country
Mexico
Facility Name
Iem-Fucam
City
D.f.
ZIP/Postal Code
04980
Country
Mexico
Facility Name
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk
City
Bergen
Country
Norway
Facility Name
Sørlandet Sykehus Kristiansand
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Stavanger Universitetssykehus, Helse Stavanger HF
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Centro Oncológico de Panamá
City
Panama
ZIP/Postal Code
0801
Country
Panama
Facility Name
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Szpitale Wojewodzkie w Gdyni Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Oncology Dispensary
City
Arkhangelsk
State/Province
Arhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Main Military Clinical Hospital named after N.N. Burdenko
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center; Combined Treatment
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Duran i Reynals; Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Sodersjukhuset; Onkologkliniken
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Akademiska sjukhuset, Onkologkliniken
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Universitaetsspital Basel; Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8038
Country
Switzerland
Facility Name
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital; Surgery
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Cukurova Uni Faculty of Medicine; Medical Oncology
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medipol University MF; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Ege Uni Medical Faculty Hospital; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Chemotherapy SI Dnipropetrovsk MA of MOHU
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Treatment and Prevention Institution Volyn Regional Oncology Dispensary
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Centre
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Western General Hospital; Clinical Oncology
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Guys ST Thomas Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital - London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Preston Hosptial
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Dept of Medical Oncology
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35695609
Citation
Li M, Yang B. Prognostic Value of NUSAP1 and Its Correlation with Immune Infiltrates in Human Breast Cancer. Crit Rev Eukaryot Gene Expr. 2022;32(3):45-60. doi: 10.1615/CritRevEukaryotGeneExpr.2021040248.
Results Reference
derived
PubMed Identifier
33579739
Citation
Wang H, Ma H, Sove RJ, Emens LA, Popel AS. Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer. J Immunother Cancer. 2021 Feb;9(2):e002100. doi: 10.1136/jitc-2020-002100. Erratum In: J Immunother Cancer. 2021 Oct;9(10):
Results Reference
derived
PubMed Identifier
32178964
Citation
Adams S, Dieras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Ann Oncol. 2020 May;31(5):582-589. doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20.
Results Reference
derived
PubMed Identifier
31786121
Citation
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Investigators. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):44-59. doi: 10.1016/S1470-2045(19)30689-8. Epub 2019 Nov 27.
Results Reference
derived
PubMed Identifier
30345906
Citation
Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.
Results Reference
derived
Learn more about this trial
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
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