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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02425891
First received: April 21, 2015
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
This multicenter, randomized, double-blind study will evaluate 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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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 [ Time Frame: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first) ]
  • PFS According to RECIST v1.1 in Participants with Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first) ]
  • Overall Survival (OS) in all Randomized Participants [ Time Frame: Baseline until death due to any cause (up to 53 months) ]
  • OS in Participants with Detectable PD-L1 [ Time Frame: Baseline until death due to any cause (up to 53 months) ]

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 [ Time Frame: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first) ]
  • Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants with Detectable PD-L1 [ Time Frame: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first) ]
  • Duration of Response (DOR) According to RECIST v1.1 in all Randomized Participants [ Time Frame: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first) ]
  • DOR Acccording to RECIST v1.1 in Participants with Detectable PD-L1 [ Time Frame: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs 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 [ Time Frame: Baseline up to 53 months (assessed at Day 1 of each cycle up to treatment discontinuation [approximately 53 months], every 28 days after treatment discontinuation for 1 year [overall approximately 53 months]) (cycle = 28 days) ]
  • TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants with Detectable PD-L1 [ Time Frame: Baseline up to 53 months (assessed at Day 1 of each cycle up to treatment discontinuation [approximately 53 months], every 28 days after treatment discontinuation for 1 year [overall approximately 53 months]) (cycle = 28 days) ]
  • Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Baseline up to 53 months ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [ Time Frame: Baseline up to 53 months (assessed at pre-dose [Hour 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every 8 cycles thereafter up to treatment discontinuation [approximately 53 months], 120 days after last dose [approximately 53 months]) (Cycle = 28 days) ]
  • Maximum Serum Concentration (Cmax) for Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section) ]
    Pre-dose (Hour 0), 30 minutes after end of atezolizumab infusion (infusion duration = 60 minutes) on Cycle 1 Day 1; pre-dose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16, and every 8 cycles thereafter up to treatment discontinuation (approximately 53 months), 120 days after last dose (approximately 53 months) (Cycle = 28 days)

  • Minimum Serum Concentration (Cmin) for Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section) ]
    Pre-dose (Hour 0), 30 minutes after end of atezolizumab infusion (infusion duration = 60 minutes) on Cycle 1 Day 1; pre-dose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16, and every 8 cycles thereafter up to treatment discontinuation (approximately 53 months), 120 days after last dose (approximately 53 months) (Cycle = 28 days)

  • 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) ]

Estimated Enrollment: 900
Actual Study Start Date: June 23, 2015
Estimated Study Completion Date: April 30, 2020
Estimated Primary Completion Date: April 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab Plus Nab-Paclitaxel
Participants assigned to atezolizumab plus nab-paclitaxel will receive both agents until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
Other Name: Tecentriq, MPDL3280A
Drug: Nab-Paclitaxel
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 will be administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.
Other Name: Abraxane®
Placebo Comparator: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
Drug: Nab-Paclitaxel
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 will be administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.
Other Name: Abraxane®
Drug: Placebo
Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02425891

Contacts
Contact: Reference Study ID Number: WO29522 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35249
United States, Alaska
Katmai Oncology Terminated
Anchorage, Alaska, United States, 99508
United States, Arizona
HonorHealth Research Institute - Pima Center Terminated
Scottsdale, Arizona, United States, 85258
Arizona Oncology Associates, P.C. Terminated
Tucson, Arizona, United States, 85710
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Marin Cancer Care Inc Terminated
Greenbrae, California, United States, 94904
Kaiser Permanente of Northern California Recruiting
Oakland, California, United States, 94612
Emad Ibrahim, Md, Inc Completed
Redlands, California, United States, 92373
Univ of Calif, San Francisco; Breast Cancer Center Active, not recruiting
San Francisco, California, United States, 94115
Kaiser Permanente - San Marcos Active, not recruiting
San Marcos, California, United States, 92069
Cancer Research Collaboration, Inc. Active, not recruiting
Santa Ana, California, United States, 92705
Stanford Univ School of Med; Oncology Active, not recruiting
Stanford, California, United States, 94305-5821
United States, Colorado
Kaiser Permanente Of Colorado Active, not recruiting
Denver, Colorado, United States, 80205
United States, Connecticut
Yale Cancer Center; Medical Oncology Active, not recruiting
New Haven, Connecticut, United States, 06520
Norwalk Hospital Active, not recruiting
Norwalk, Connecticut, United States, 06856
Stamford Hospital; BCC, MOHR Active, not recruiting
Stamford, Connecticut, United States, 06904
United States, District of Columbia
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) Active, not recruiting
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Florida Cancer Specialists - SCRI; Pharmacy Active, not recruiting
Fort Myers, Florida, United States, 33901
Mayo Clinic Withdrawn
Jacksonville, Florida, United States, 32224
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) Completed
Jacksonville, Florida, United States, 32256
The Mount Siani Comprehensive Cancer Center Active, not recruiting
Miami Beach, Florida, United States, 33140
Florida Cancer Research Institute Completed
Plantation, Florida, United States, 33324
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) Active, not recruiting
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Northwest Georgia Oncology Centers PC - Marietta Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center - Chicago Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Louisiana
University hospitals and clinics Terminated
Lafayette, Louisiana, United States, 70506
LSU Health Sciences Center Terminated
New Orleans, Louisiana, United States, 70112
United States, Maryland
Mercy Medical Center Active, not recruiting
Baltimore, Maryland, United States, 21202
John Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Maryland Oncology Hematology Recruiting
Westminster, Maryland, United States, 21157
United States, Massachusetts
Massachusetts General Hospital Terminated
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr; Hem/Onc Terminated
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute Terminated
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute; Oncology Active, not recruiting
Detroit, Michigan, United States, 48201
West Michigan Cancer Center Active, not recruiting
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
Jackson Oncology Associates, PLLC Active, not recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC Active, not recruiting
Kansas City, Missouri, United States, 64132
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
New Hampshire Hematology Oncology Recruiting
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
Hackensack U Med Ctr Active, not recruiting
Hackensack, New Jersey, United States, 07601
The Valley Hospital Active, not recruiting
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
San Juan Oncology Associates Terminated
Farmington, New Mexico, United States, 87401
United States, New York
New York Oncology Hematology, P.C. Terminated
Albany, New York, United States, 12206
ProHEALTH Care Associates LLP Active, not recruiting
Lake Success, New York, United States, 11042
Laura and ISAAC Perlmutter Cancer Center at NYU Langone. Active, not recruiting
New York, New York, United States, 10016
Montefiore Medical Center Active, not recruiting
The Bronx, New York, United States, 10467
United States, Ohio
Onc/Hem Care Clin Trials LLC Active, not recruiting
Cincinnati, Ohio, United States, 45242
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. Active, not recruiting
Columbus, Ohio, United States, 43219
United States, Oregon
Kaiser Perm NW - Rheuma Active, not recruiting
Portland, Oregon, United States, 97227
Providence Cancer Center Active, not recruiting
Portland, Oregon, United States, 97231
United States, Pennsylvania
St. Luke's Cancer Care Associates Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
Magee Womens Hospital Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Women and Infants Hospital of Rhode Island Terminated
Providence, Rhode Island, United States, 02906
United States, South Carolina
South Carolina Oncology Associates - SCRI Withdrawn
Columbia, South Carolina, United States, 29210
Greenville Health System (GHS) Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Wellmont Bristol Regional Medical Center Recruiting
Bristol, Tennessee, United States, 37620
West Clinic Active, not recruiting
Germantown, Tennessee, United States, 38138
Tennessee Cancer Specialists Terminated
Knoxville, Tennessee, United States, 37920
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc Active, not recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology- El Paso Cancer Treatment Center Gateway Active, not recruiting
El Paso, Texas, United States, 79915
The Methodist Cancer Center Recruiting
Houston, Texas, United States, 77030
University of Texas;M.D. Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
United States, Virginia
Inova Medical Group Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Cancer Care Northwest Active, not recruiting
Spokane, Washington, United States, 99204
Northwest Cancer Specialists - Vancouver Terminated
Vancouver, Washington, United States, 98684
Yakima Valley Memorial Hospital/North Star Lodge Terminated
Yakima, Washington, United States, 98902
Argentina
Centro de Oncologia e Investigacion Buenos Aires (COIBA) Active, not recruiting
Buenos Aires, Argentina, B1884BBF
Fundacion Investigar Active, not recruiting
Caba, Argentina, C1025ABI
Centro Oncologico Riojano Integral (CORI) Active, not recruiting
La Rioja, Argentina, F5300COE
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Nepean Cancer Care Centre Recruiting
Sydney, New South Wales, Australia, 2747
Australia, Queensland
Icon Cancer Foundation Recruiting
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital; Division of Cancer Services Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Peninsula and South Eastern Haematology and Oncology Grou Active, not recruiting
Frankston, Victoria, Australia, 3199
Peter MacCallum Cancer Centre; Medical Oncology Recruiting
Melbourne, Victoria, Australia, 3000
Sunshine Hospital Active, not recruiting
St Albans, Victoria, Australia, 3021
Australia, Western Australia
St John of God Hospital; Bendat Cancer Centre Active, not recruiting
Subiaco, Western Australia, Australia, 6008
Austria
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I Recruiting
Graz, Austria, 8036
Kh Der Barmherzigen Schwestern; Interne I X Recruiting
Linz, Austria, 4010
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. Active, not recruiting
Salzburg, Austria, 5020
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie Active, not recruiting
Steyr, Austria, 4400
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie Active, not recruiting
Wien, Austria, 1090
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I Recruiting
Wien, Austria, 1090
Belgium
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
Cliniques Universitaires St-Luc Recruiting
Bruxelles, Belgium, 1200
GHdC Site Notre Dame Recruiting
Charleroi, Belgium, 6000
AZ Groeninge (Loofstraat) Recruiting
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg Active, not recruiting
Leuven, Belgium, 3000
Sint Augustinus Wilrijk Active, not recruiting
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
University Clinical Center of the Republic of Srpska Active, not recruiting
Banja Luka, Bosnia and Herzegovina, 78000
Clinic of Oncology, University Clinical Center Sarajevo Active, not recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Santa Casa de Misericordia de Salvador; Oncologia Active, not recruiting
Salvador, BA, Brazil, 40050-410
Crio - Centro Regional Integrado de Oncologia Active, not recruiting
Fortaleza, CE, Brazil, 60336-550
Hospital Araujo Jorge; Departamento de Ginecologia E Mama Active, not recruiting
Goiania, GO, Brazil, 74605-070
Hospital de Caridade de Ijui; Oncologia Active, not recruiting
Ijui, RS, Brazil, 98700-000
Hospital de Clinicas de Porto Alegre;Centro de Pesquisa Clinica Active, not recruiting
Porto Alegre, RS, Brazil, 90035-003
Hospital Sao Lucas - PUCRS Active, not recruiting
Porto Alegre, RS, Brazil, 90610-000
Centro de Pesquisas Oncologicas - CEPON Active, not recruiting
Florianopolis, SC, Brazil, 88034-000
Clinica de Neoplasias Litoral Active, not recruiting
Itajai, SC, Brazil, 88301-220
Hospital Perola Byington Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Hospital Sao Jose Active, not recruiting
São Paulo, SP, Brazil, CEP 01321-001
Canada, Alberta
Tom Baker Cancer Centre-Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute ; Dept of Medical Oncology Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Bcca - Cancer Center Southern Interior Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Bcca-Fraser Valley Cancer Centre Terminated
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
QEII HSC; Oncology Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Kingston General Hospital Active, not recruiting
Kingston, Ontario, Canada, K7L 2V6
Lakeridge Health Oshawa; Oncology Active, not recruiting
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K2H 6C2
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology Recruiting
Montreal, Quebec, Canada, H3T 1E2
Hospital Du Saint-Sacrement Active, not recruiting
Quebec City, Quebec, Canada, G1S 4L8
Chile
Fundacion Arturo Lopez Perez Terminated
Santiago, Chile, 7500921
Centro de Cancer Pontificie Universidad Catolica de Chile Active, not recruiting
Santiago, Chile, 8330074
Centro Internacional de Estudios Clínicos (CIEC) Terminated
Santiago, Chile, 8420383
Instituto Clínico Oncolo gico del Sur Active, not recruiting
Temuco, Chile, 4810469
Colombia
Clinica del Country Active, not recruiting
Bogota, Colombia, 11001
Oncologos De Occidente, Manizales Terminated
Manizales, Colombia
Oncomedica S.A. Active, not recruiting
Monteria, Colombia, 230002
Costa Rica
Clinica CIMCA Active, not recruiting
San Jose, Costa Rica, 10103
ICIMED Instituto de Investigación en Ciencias Médicas Recruiting
San Jose, Costa Rica, 10108
Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika Active, not recruiting
Olomouc, Czechia, 779 00
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika Active, not recruiting
Praha 2, Czechia, 128 08
Fakultni nemocnice v Motole Active, not recruiting
Praha 5, Czechia, 150 06
Denmark
Herlev Hospital; Onkologisk afdeling Terminated
Herlev, Denmark, 2730
Rigshospitalet, Onkologisk Klinik Terminated
København Ø, Denmark, 2100
Odense Universitetshospital, Onkologisk Afdeling R Terminated
Odense, Denmark, 5000
Vejle Sygehus Onkologisk Afd Terminated
Vejle, Denmark, 7100
Estonia
North Estonia Medical Centre Foundation; Oncology Centre Recruiting
Tallinn, Estonia, 13419
Tartu Uni Hospital; Hematology - Oncology Clinic Active, not recruiting
Tartu, Estonia, 51014
Finland
Oulu University Hospital; Oncology Terminated
Oulu, Finland, 90029
KYS Sädesairaala Terminated
Sädesairaala, Finland, 70210
Tampere University Hospital; Dept of Oncology Active, not recruiting
Tampere, Finland, 33520
Turku Uni Central Hospital; Oncology Clinics Terminated
Turku, Finland, 20520
France
Ico - Paul Papin Active, not recruiting
Angers, France, 49000
Institut Sainte Catherine Recruiting
Avignon, France, 84918
Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Institut Bergonie CLCC Bordeaux Withdrawn
Bordeaux, France, 33000
Centre Francois Baclesse; Comite Sein Active, not recruiting
Caen, France, 14076
HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale Active, not recruiting
Grenoble, France, 38043
Centre Oscar Lambret Recruiting
Lille, France, 59020
Centre Leon Berard Recruiting
Lyon, France, 69008
Institut régional du Cancer Montpellier Recruiting
Montpellier, France, 34298
Clinique Catherine de Sienne Active, not recruiting
Nantes, France, 44202
Institut Curie Active, not recruiting
Paris, France, 75005
Hopital La Pitie Salpetriere Active, not recruiting
Paris, France, 75013
Institut De Cancerologie De L'Ouest; Medical Oncology Active, not recruiting
Saint Herblain, France, 44115
Centre Paul Strauss Recruiting
Strasbourg, France, 67085
Germany
Onkologische Schwerpunktpraxis Kurfürstendamm Terminated
Berlin, Germany, 10707
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters Recruiting
Berlin, Germany, 13581
St. Johannes Hospital; Abt. für Hämatologie und Onkologie Recruiting
Dortmund, Germany, 44137
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden Recruiting
Dresden, Germany, 01307
Universitätsklinikum Erlangen; Frauenklinik Recruiting
Erlangen, Germany, 91054
Uniklinik Essen; Gynäkologie Recruiting
Essen, Germany, 45122
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH Recruiting
Georgsmarienhütte, Germany, 49124
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie Active, not recruiting
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik Recruiting
Hamburg, Germany, 20246
Facharztzentrum Eppendorf, Studien GbR Active, not recruiting
Hamburg, Germany, 20249
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding Terminated
Hannover, Germany, 30177
Universitatsklinik Heidelberg; Universitatshautklinik und Nationales Centrum fur Tumorerkrankungen Recruiting
Heidelberg, Germany, 69120
Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin Recruiting
Koblenz, Germany, 56068
St. Elisabeth-Krankenhaus; Brustzentrum Recruiting
Köln, Germany, 50935
Universitätsklinikum Schleswig-Holstein; Campus Lübeck Recruiting
Lübeck, Germany, 23538
Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie Terminated
Magdeburg, Germany, 39130
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik Recruiting
München, Germany, 81675
Gemeinschaftspraxis für Hämatologie und Onkologie Recruiting
Münster, Germany, 48149
MVZ Nordhausen gGmbH, Praxis Dr. Grafe Recruiting
Nordhausen, Germany, 99734
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe Withdrawn
Offenbach, Germany, 63069
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie Active, not recruiting
Recklinghausen, Germany, 45657
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt Recruiting
Rostock, Germany, 18059
Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie Recruiting
Trier, Germany, 54219
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis Recruiting
Troisdorf, Germany, 53840
Universitätsklinik Tübingen; Frauenklinik & Poliklinik Active, not recruiting
Tübingen, Germany, 72076
Greece
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine Recruiting
Athens, Greece, 115 22
IASO General Hospital of Athens Recruiting
Athens, Greece, 155 62
Univ General Hosp Heraklion; Medical Oncology Recruiting
Heraklion, Greece, 711 10
University Hospital of Patras Medical Oncology Recruiting
Patras, Greece, 265 04
Euromedical General Clinic of Thessaloniki; Oncology Department Recruiting
Thessaloniki, Greece, 546 45
Guatemala
Grupo Angeles Recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Queen Elizabeth Hospital; Clinical Oncology Active, not recruiting
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Medicine Recruiting
Hong Kong, Hong Kong
Tuen Mun Hospital; Clinical Oncology Active, not recruiting
Hong Kong, Hong Kong
Hungary
Semmelweis Egyetem Onkologiai Központ Active, not recruiting
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly Active, not recruiting
Budapest, Hungary, 1122
Fövárosi Önkormányzat uzsoki utcai Kórház Active, not recruiting
Budapest, Hungary, 1145
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Active, not recruiting
Szeged, Hungary, 6720
Italy
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica Withdrawn
Napoli, Campania, Italy, 80131
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica Active, not recruiting
Napoli, Campania, Italy, 80131
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica Withdrawn
Roma, Lazio, Italy, 00128
Asst Papa Giovanni XXIII; Oncologia Medica Terminated
Bergamo, Lombardia, Italy, 24128
Irccs Ospedale San Raffaele;Oncologia Medica Terminated
Milano, Lombardia, Italy, 20132
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica Active, not recruiting
Milano, Lombardia, Italy, 20141
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia Withdrawn
Rozzano, Lombardia, Italy, 20089
Ospedale Vito Fazzi; Div. Oncoematologia Active, not recruiting
Lecce, Puglia, Italy, 73100
Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica Terminated
Grosseto, Toscana, Italy, 58100
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda Withdrawn
Padova, Veneto, Italy, 35128
Japan
Aichi Cancer Center Hospital Recruiting
Aichi, Japan, 464-8681
National Hospital Organization Shikoku Cancer Center Active, not recruiting
Ehime, Japan, 791-0280
Fukushima Medical University Hospital Recruiting
Fukushima, Japan, 960-1295
Gunma Prefectural Cancer Center Recruiting
Gunma, Japan, 373-8550
Hiroshima City Hiroshima Citizens Hospital Recruiting
Hiroshima, Japan, 730-8518
Hiroshima University Hospital Active, not recruiting
Hiroshima, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center Recruiting
Hokkaido, Japan, 003-0804
Hyogo College of Medicine Hospital Recruiting
Hyogo, Japan, 663-8501
Tokai University Hospital Recruiting
Isehara-shi, Japan, 259-1193
Sagara Hospital Recruiting
Kagoshima, Japan, 892-0833
St. Marianna University School of Medicine Hospital Active, not recruiting
Kanagawa, Japan, 216-8511
Kumamoto University Hospital Active, not recruiting
Kumamoto, Japan, 860-8556
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Mie University Hospital Recruiting
Mie, Japan, 514-8507
Tohoku University Hospital Active, not recruiting
Miyagi, Japan, 980-8574
Niigata Cancer Center Hospital Active, not recruiting
Niigata-shi, Japan, 951-8566
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Naha-nishi Clinic Recruiting
Okinawa, Japan, 901-0154
National Hospital Organization Osaka National Hospital Recruiting
Osaka, Japan, 540-0006
Osaka International Cancer Institute Active, not recruiting
Osaka, Japan, 541-8567
Kindai University Hospital Recruiting
Osaka, Japan, 589-8511
Saitama Medical University International Medical Center Active, not recruiting
Saitama, Japan, 350-1298
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Shizuoka General Hospital Active, not recruiting
Shizuoka-shi, Japan, 420-8527
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 411-8777
National Cancer Center Hospital Active, not recruiting
Tokyo, Japan, 104-0045
St. Luke's International Hospital Active, not recruiting
Tokyo, Japan, 104-8560
Toranomon Hospital Active, not recruiting
Tokyo, Japan, 105-8470
Komagome Hospital Active, not recruiting
Tokyo, Japan, 113-8677
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center Active, not recruiting
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Latvia
Daugavpils Regional Hospital Active, not recruiting
Daugavpils, Latvia, 5417
Riga East Clinical University Hospital Latvian Oncology Centre Active, not recruiting
Riga, Latvia, LV-1079
Mexico
Centro Médico Zambrano Hellion Recruiting
Monterrey, Nuevo Leon, Mexico, 66278
Instituto Estatal de Cancerologia Colima Active, not recruiting
Colima, Mexico, 28000
Iem-Fucam Active, not recruiting
D.f., Mexico, 04980
Centro Medico Dalinde Active, not recruiting
D.f., Mexico, 06760
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco Active, not recruiting
Mexico City, Mexico, 03100
Norway
Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk Recruiting
Bergen, Norway
Sørlandet Sykehus Kristiansand Recruiting
Kristiansand, Norway, 4604
Stavanger Universitetssykehus, Helse Stavanger HF Recruiting
Stavanger, Norway, 4011
Panama
Centro Oncológico de Panamá Active, not recruiting
Panama, Panama, 082400133
Poland
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii Active, not recruiting
Bydgoszcz, Poland, 85-796
Szpitale Wojewodzkie w Gdyni Sp. z o.o. Active, not recruiting
Gdynia, Poland, 81-519
Przychodnia Lekarska KOMED Active, not recruiting
Konin, Poland, 62-500
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii Active, not recruiting
Krakow, Poland, 31-531
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii Completed
Lublin, Poland, 20-090
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon Active, not recruiting
Warszawa, Poland, 02-781
Wojskowy Instytut Medyczny Completed
Warszawa, Poland, 04-141
Mazowiecki Szpital Onkologiczny Terminated
Wieliszew, Poland, 05-135
Portugal
Hospital de Braga; Servico de Oncologia Medica X Withdrawn
Braga, Portugal, 4710-243
IPO de Lisboa; Servico de Oncologia Medica Withdrawn
Lisboa, Portugal, 1099-023
Hospital de Santa Maria; Servico de Oncologia Medica Withdrawn
Lisboa, Portugal, 1649-035
IPO do Porto; Servico de Oncologia Medica Withdrawn
Porto, Portugal, 4200-072
Romania
Prof. Dr. I. Chiricuta Institute of Oncology Withdrawn
Cluj Napoca, Romania, 400015
Euroclinic Center of Oncology SRL Active, not recruiting
Iasi, Romania, 700106
Oncomed SRL Active, not recruiting
Timisoara, Romania, 300239
Russian Federation
Moscow City Oncology Hospital #62 Active, not recruiting
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Arkhangelsk Regional Clinical Oncology Dispensary Active, not recruiting
Arkhangelsk, Russian Federation, 163045
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153040
Clinical Oncology Dispensary of Ministry of Health of Tatarstan Active, not recruiting
Kazan, Russian Federation, 420029
Main Military Clinical Hospital named after N.N. Burdenko Recruiting
Moscow, Russian Federation, 105229
Blokhin Cancer Research Center; Combined Treatment Active, not recruiting
Moscow, Russian Federation, 115478
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Active, not recruiting
Saint-Petersburg, Russian Federation, 197758
Samara Regional Oncology Dispensary Withdrawn
Samara, Russian Federation, 443031
Serbia
Institute for Onc/Rad Serbia Terminated
Belgrade, Serbia, 11000
Clinical Center Bezanijska Kosa Recruiting
Belgrade, Serbia, 11070
Institute for oncology of Vojvodina Terminated
Sremska Kamenica, Serbia, 21204
Singapore
National University Hospital Active, not recruiting
Singapore, Singapore, 119074
National Cancer Centre Active, not recruiting
Singapore, Singapore, 169610
Slovenia
Institute of Oncology Ljubljana Active, not recruiting
Ljubljana, Slovenia, 1000
Spain
Hospital de Donostia; Servicio de Oncologia Medica Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Hospital del Mar; Servicio de Oncologia Recruiting
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia Recruiting
Barcelona, Spain, 08035
Hospital Duran i Reynals; Oncologia Recruiting
Barcelona, Spain, 08907
Hospital Universitario Reina Sofia; Servicio de Oncologia Recruiting
Cordoba, Spain, 14004
Hospital Universitario 12 de Octubre; Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia Recruiting
Madrid, Spain, 28046
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Recruiting
Malaga, Spain, 29010
Instituto Valenciano Oncologia; Oncologia Medica Recruiting
Valencia, Spain, 46009
Sweden
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling Terminated
Malmö, Sweden, 205 02
Sodersjukhuset; Onkologkliniken Recruiting
Stockholm, Sweden, 118 83
Akademiska sjukhuset, Onkologkliniken Active, not recruiting
Uppsala, Sweden, 75185
Universitetssjukhuset Örebro, Onkologiska kliniken Terminated
Örebro, Sweden, 701 85
Switzerland
Universitaetsspital Basel; Onkologie Completed
Basel, Switzerland, 4031
Kantonsspital Graubünden;Onkologie und Hämatologie Terminated
Chur, Switzerland, 7000
Kantonsspital St. Gallen; Brustzentrum Recruiting
St. Gallen, Switzerland, 9007
OnkoZentrum Zuerich Active, not recruiting
Zürich, Switzerland, 8038
Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery Recruiting
Kaohsiung, Taiwan, 807
China Medical University Hospital; Surgery Recruiting
Taichung, Taiwan, 404
VETERANS GENERAL HOSPITAL; Department of General Surgery Recruiting
Taipei, Taiwan, 00112
National Taiwan Uni Hospital; General Surgery Recruiting
Taipei, Taiwan, 100
Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Active, not recruiting
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Active, not recruiting
Bangkok, Thailand, 10700
Prince of Songkla Uni ; Unit of Medical Oncology Active, not recruiting
Songkhla, Thailand, 90110
Turkey
Cukurova Uni Faculty of Medicine; Medical Oncology Recruiting
Adana, Turkey, 01330
Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department Recruiting
Istanbul, Turkey, 34098
Medipol University Medical Faculty; Oncology Department Active, not recruiting
Istanbul, Turkey, 34214
Ege Uni Medical Faculty Hospital; Oncology Dept Recruiting
Izmir, Turkey, 35100
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department Terminated
Malatya, Turkey, 44280
Hacettepe Uni Medical Faculty Hospital; Oncology Dept Recruiting
Sıhhiye, ANKARA, Turkey, 06100
Ukraine
CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU Active, not recruiting
Dnipropetrovsk, Ukraine, 49102
Kyiv City Clinical Oncological Center Recruiting
Kyiv, Ukraine, 03115
Treatment and Prevention Institution Volyn Regional Oncology Dispensary Recruiting
Lutsk, Ukraine, 43018
Lviv State Oncology Regional Treatment and Diagnostic Centre Active, not recruiting
Lviv, Ukraine, 79031
United Kingdom
Velindre Cancer Centre Active, not recruiting
Cardiff, United Kingdom, CF14 2TL
Western General Hospital; Clinical Oncology Active, not recruiting
Edinburgh, United Kingdom, EH4 2XU
St Bartholomew's Hospital Active, not recruiting
London, United Kingdom, EC1A 7BE
Guys ST Thomas Hospital Active, not recruiting
London, United Kingdom, SE1 9RT
Royal Marsden Hospital Active, not recruiting
London, United Kingdom, SW3 6JJ
Christie Hospital Nhs Trust; Medical Oncology Active, not recruiting
Manchester, United Kingdom, M2O 4BX
Nottingham University Hospitals NHS Trust Withdrawn
Nottingham, United Kingdom, NG7 2UH
Derriford Hospital Active, not recruiting
Plymouth, United Kingdom, PL6 8DH
Royal Preston Hosptial Active, not recruiting
Preston, United Kingdom, PR2 9HT
Weston Park Hospital Recruiting
Sheffield, United Kingdom, S10 2SJ
Royal Marsden Hospital; Dept of Medical Oncology Completed
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02425891     History of Changes
Other Study ID Numbers: WO29522
2014-005490-37 ( EudraCT Number )
Study First Received: April 21, 2015
Last Updated: June 16, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017