Spots Global Cancer Trial Database for Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
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Trial Identification
Brief Title: Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
Official Title:
Study ID: NCT02402712
Conditions
Study Description
Brief Summary: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
AZ Sint Jan, Brugge, , Belgium
UZ Brussel, Brussel, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Clinique Saint-Joseph, Liège, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC, Gabrovo, , Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD, Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv, , Bulgaria
Comprehensive Cancer Center-Plovdiv, Plovdiv, , Bulgaria
Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD, Sofia, , Bulgaria
Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd, Varna, , Bulgaria
MDOZS Vrasta Ltd., Vratsa, , Bulgaria
Moncton Hospital, Moncton, New Brunswick, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy, Ars-Laquenexy, , France
Medipole De Savoie; Departement Oncologie, Challes Les Eaux, , France
Hopital Prive Sainte Marie, Chalon sur Saone, , France
Centre Hospitalier Louis Pasteur, Chartes Le Coudray, , France
Pole Sante Republique; Pharmacie Oncologique, Clermont Ferrand, , France
Centre Georges Francois Leclerc, Dijon, , France
Groupe Hospitalier Mutualiste de Grenoble, Grenoble Cedex, , France
CHU de Grenoble, Grenoble, , France
Hopital Europeen, Marseille, , France
Centre Hospitalier de Mont de Marsan - Hopital Layne, Mont De Marsan, , France
Hopital Saint Joseph; Service de Rhumatologie, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Strasbourg Oncologie Libérale, Strasbourg, , France
Gustave Roussy, Villejuif CEDEX, , France
Studienzentrum Aschaffenburg, Aschaffenburg, , Germany
Onkologische Schwerpunktpraxis Dr. Joerg Schilling, Berlin, , Germany
Universitaetsklinikum Erlangen, Erlangen, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg, , Germany
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I, Lubeck, , Germany
Onkologische Schwerpunktpraxis Lübeck, Lübeck, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Suedharz Klinikum Nordhausen gGmbH, Nordhausen, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe, Offenbach, , Germany
Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie, Stendal, , Germany
Klinikum Mutterhaus der Borromaeerinnen, Trier, , Germany
Universitätsklinikum Würzburg, Wuerzburg, , Germany
Szent Margit Hospital; Dept. of Oncology, Budapest, , Hungary
Ogyi, Orszagos Gyogyszereszeti Intezet, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Szent Imre Egyetemi Oktatokorhaz, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Budapest, , Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc, , Hungary
Azienda Ospedaliera Regionale San Carlo, Potenza, Basilicata, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Emilia-Romagna, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena, Emilia-Romagna, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova, Reggio Emilia, Emilia-Romagna, Italy
Ospedale Infermi di Rimini, Rimini, Emilia-Romagna, Italy
Istituti Fisioterapici Ospitalieri, Roma, Lazio, Italy
Ospedale Policlinico San Martino, Genova, Liguria, Italy
Asst Papa Giovanni XXIII, Bergamo, Lombardia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
Istituto Clinico Humanitas, Rozzano (MI), Lombardia, Italy
Asst Della Valtellina E Dell'Alto Lario, Sondrio, Lombardia, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele, Catania, Sicilia, Italy
Ospedale Santa Maria Annunziata, Bagno A Ripoli, Toscana, Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, Toscana, Italy
Azienda USL 5 di Pisa, Pisa, Toscana, Italy
Ospedale Santo Stefano, Azienda USL Centro Prato, Prato, Toscana, Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, Umbria, Italy
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, Cona (Ferrara), Veneto, Italy
Ospedale Sacro Cuore Don Calabria, Negrar, Veneto, Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, Veneto, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento", Verona, Veneto, Italy
Consultorio de Medicina Especializada, Mexico, Mexico CITY (federal District), Mexico
Grupo Medico Camino, DF, , Mexico
Superare Centro de Infusion S.A. de C.V., Mexico, , Mexico
Fundacion de Cancer de Mama.A.C., Mexico, , Mexico
Centro Medico San Jose, Monterrey, Nuevo Leon, , Mexico
Cancerología, Queretaro, , Mexico
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie, Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk, , Poland
Szpitale Pomorskie Sp. z o. o., Gdynia, , Poland
Przychodnia Lekarska KOMED, Konin, , Poland
Szpital Uniwersytecki w Krakowie, Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie, Olsztyn, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii, Opole, , Poland
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna, Poznan, , Poland
Wielkopolskie Centrum Onkologii, Poznan, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna, Warsaw, , Poland
MAGODENT Sp. z o.o., Warsaw, , Poland
Hospital de Braga, Braga, , Portugal
Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE, Coimbra, , Portugal
Hospital da Luz, Lisboa, , Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario, Santiago de Compostela, LA Coruña, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, , Spain
Fundacion Instituto Valenciano de Oncologia (IVO), Valencia, , Spain
Betsi Cadwaladr University Health Board, Bangor Gwynedd, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Dorset County Hospital, Dorchester, , United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary, Leicester, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
Peterborough City Hospital, Peterborough, , United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital, Portsmouth, , United Kingdom
Royal Cornwall Hospitals NHS Trust, Truro, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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