A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
- Registration Number
- NCT01152606
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3942
- All patients who are considered candidates to receive Herceptin for this indication
- Patients for whom Herceptin is contraindicated
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort trastuzumab [Herceptin] -
- Primary Outcome Measures
Name Time Method Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death On treatment and up to 5 years follow-up
- Secondary Outcome Measures
Name Time Method Time to onset and the time to recovery of symptomatic congestive heart failure On treatment and up to 5 years follow-up Incidence of asymptomatic cardiac failure and other significant cardiac conditions On treatment and up to 5 years follow-up
Trial Locations
- Locations (205)
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
🇦🇹Graz, Austria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
🇦🇹Graz, Austria
LKH Hochsteiermark; Abt. für Innere Medizin
🇦🇹Leoben, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
🇦🇹Salzburg, Austria
Lhk Feldkirch; Interne Medizin Abt.
🇦🇹Rankweil, Austria
A. Ö. Krankenhaus Der Barmherzigen Brüder; Abt. Für Chirurgie
🇦🇹St Veit An Der Glan, Austria
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
🇦🇹Steyr, Austria
Lhk Vöcklabruck; Ii. Interne Abt.
🇦🇹Vöcklabruck, Austria
Krankenanstalt Rudolfstiftung; I. Med. Abt.
🇦🇹Wien, Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
🇦🇹Wien, Austria
CH EpiCURA Site Louis Caty
🇧🇪Baudour, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Belgium
AZ KLINA
🇧🇪Brasschaat, Belgium
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
Clinique St Pierre asbl
🇧🇪Ottignies, Belgium
AZ Delta (Campus Wilgenstraat)
🇧🇪Roeselare, Belgium
AZ Turnhout Sint Elisabeth
🇧🇪Turnhout, Belgium
Sint Augustinus Wilrijk
🇧🇪Wilrijk, Belgium
Internist; Praxis Für Haemotologie & Onkologie
🇩🇪Bad Soden, Germany
Studienzentrum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Brustzentrum Bassum
🇩🇪Bassum, Germany
DRK Kliniken Berlin Köpenick, Frauenklinik
🇩🇪Berlin, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
🇩🇪Berlin, Germany
Praxis Dr. Schoenegg
🇩🇪Berlin, Germany
Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
🇩🇪Bonn, Germany
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
🇩🇪Bielefeld, Germany
Onkologisches Zentrum; Oncology
🇩🇪Donauwörth, Germany
Praxis Dr Geuther
🇩🇪Berlin, Germany
Medizinisches Versorgungszentrum Bonn
🇩🇪Bonn, Germany
Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
🇩🇪Donauwörth, Germany
St. Johannes Hospital
🇩🇪Dortmund, Germany
Praxis im Elbcenter 1 in Dresden-Pieschen; Dr. med. Thomas Goehler & Dipl.-Med. Steffen Doerfel
🇩🇪Dresden, Germany
Kreisklinik Ebersberg; Abteilung für Gynäkologie & Geburtshilfe
🇩🇪Ebersberg, Germany
Universitätsklinikum Düsseldorf; Frauenklinik
🇩🇪Düsseldorf, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf
🇩🇪Dresden, Germany
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
🇩🇪Dresden, Germany
Universitätsklinikum Erlangen; Frauenklinik
🇩🇪Erlangen, Germany
Uniklinik Essen; Gynäkologie
🇩🇪Essen, Germany
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
🇩🇪Frankfurt am Main, Germany
Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe
🇩🇪Georgsmarienhütte, Germany
Wilhelm-Anton-Hospital Klinik f.Hämatologie und internistische Onkologie
🇩🇪Goch, Germany
Klinikum Fulda gAG; Frauenklinik
🇩🇪Fulda, Germany
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
🇩🇪Hamburg, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
🇩🇪Hamburg, Germany
Martin-Luther-Universität Halle-Wittenberg
🇩🇪Halle, Germany
Praxis Harburger Ring
🇩🇪Hamburg, Germany
Dres. Sigrun Müller-Hagen Mathias Bertram und Ulrich Stein
🇩🇪Hamburg, Germany
Iorc-Innovation Onkologie& Research& Consulting Gmbh; Praxis Lerchenfeld Hamburg
🇩🇪Hamburg, Germany
SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
🇩🇪Hameln, Germany
Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
🇩🇪Jena, Germany
Diakovere Henriettenstift, Frauenklinik
🇩🇪Hannover, Germany
Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
🇩🇪Homburg/Saar, Germany
Westpfalz-Klinikum GmbH; Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Kaiserslautern, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
🇩🇪Hannover, Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
🇩🇪Herne, Germany
Gemeinschaftspraxis Dr. Siehl & Dr. Soeling
🇩🇪Kassel, Germany
Systemedic Frauenarzte Pruener Gang
🇩🇪Kiel, Germany
Gemeinschaftspraxis Für Haematologie/Onkologie
🇩🇪Köln, Germany
Uniklinik Köln; Klinik Für Frauenheilkunde
🇩🇪Köln, Germany
Asklepios Klinik; Abt. Gynäkologie
🇩🇪Langen, Germany
Klinik Lippe Lemgo; Medizinische Klinik II/Haematoonkologie
🇩🇪Lemgo, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Lübeck, Germany
Onkologische Gemeinschaftspraxis
🇩🇪Magdeburg, Germany
Universitätsklinikum Marburg; Gynäkologie
🇩🇪Marburg, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
🇩🇪Mainz, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
🇩🇪Münster, Germany
Ev. Krankenhaus
🇩🇪Mülheim, Germany
Praxis Für Haematologie & Onkologie Dr. B. Otremba
🇩🇪Oldenburg, Germany
Praxis Frau Dr. Schwarz
🇩🇪Oranienburg, Germany
Klinikum Passau; 2. Medizinische Klinik; Onkologie und Hämatologie
🇩🇪Passau, Germany
Agaplesion Diakonieklinikum Rotenburg
🇩🇪Rotenburg-wuemme, Germany
Krankenhaus Rheinfelden; Frauenklinik
🇩🇪Rheinfelden, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
🇩🇪Saarbruecken, Germany
Klinik Saarbrücken Ggmbh; Brustzentrum
🇩🇪Saarbruecken, Germany
Praxis Dr. Wagner
🇩🇪Saarbruecken, Germany
DRK Krankenhaus Saarlouis; Kooperatives Brustzentrum
🇩🇪Saarlouis, Germany
Marienkrankenhaus Abt. Gynäkologie und Geburtshilfe
🇩🇪Saint Wendel, Germany
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
🇩🇪Stade, Germany
Katharinen-Hospital gGmbH
🇩🇪Unna, Germany
Johanniter-Krankenhaus
🇩🇪Stendal, Germany
Klinikum Traunstein
🇩🇪Traunstein, Germany
Klinik Der Hansestadt Stralsund Gmbh; Frauenklinik
🇩🇪Stralsund, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
🇩🇪Trier, Germany
Semmelweis Egyetem Onkologiai Központ
🇭🇺Budapest, Hungary
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
🇭🇺Budapest, Hungary
Gemeinschaftspraxis Hämatologie / Onkologie
🇩🇪Wiesbaden, Germany
Vas Megyei Markusovszky Korhaz ; Pulmonology
🇭🇺Szombathely, Hungary
Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
🇮🇹Latina, Lazio, Italy
Ospedale San Giacomo in Augusta; Reparto Oncologia
🇮🇹Roma, Lazio, Italy
Azienda Complesso Ospedaliero S. Filippo Neri; Divisione Di Oncologia Medica
🇮🇹Roma, Lazio, Italy
Arcispedale S.Anna; Oncologia Medica
🇮🇹Cona (Ferrara), Veneto, Italy
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
🇵🇱Poznan, Poland
Polo Ospedaliero Santorso
🇮🇹Santorso, Veneto, Italy
Regionalne Centrum Onkologi; Oddzial Chorob Wewnetrznych I Onkologii
🇵🇱Bydgoszcz, Poland
Hospital Universitario de Canarias;servicio de Oncologia
🇪🇸La Laguna, Tenerife, Spain
Hospital General de Mataro; Servicio de Oncologia
🇪🇸Mataro, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
🇪🇸Sabadell, Barcelona, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
🇪🇸Jaen, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
🇪🇸Sevilla, Spain
Hospital de Navarra; Servicio de Oncologia
🇪🇸Navarra, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
🇪🇸Zaragoza, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
🇪🇸Toledo, Spain
Centralsjukhuset Karlstad, Onkologkliniken
🇸🇪Karlstad, Sweden
Uni Hospital Linkoeping; Dept. of Oncology
🇸🇪Linköping, Sweden
Länssjukhuset Kalmar; Oncology
🇸🇪Kalmar, Sweden
Skånes University Hospital, Skånes Department of Onclology
🇸🇪Lund, Sweden
Karolinska Hospital; Oncology - Radiumhemmet
🇸🇪Stockholm, Sweden
Länssjukhuset Sundsvall, Onkologkliniken
🇸🇪Sundsvall, Sweden
Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
🇸🇪Umea, Sweden
Aberdeen Royal Infirmary; Medical Oncology Dept
🇬🇧Aberdeen, United Kingdom
Belfast City Hospital; Dept of Oncology
🇬🇧Belfast, United Kingdom
Velindre Cancer Centre; Oncology Dept
🇬🇧Cardiff, United Kingdom
Ninewells Hospital; Dept of Radiotherapy & Oncology
🇬🇧Dundee, United Kingdom
Broomfield Hospital; Oncology
🇬🇧Chelmsford, United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
🇬🇧Exeter, United Kingdom
St Thomas Hospital; Medicine Div.
🇬🇧London, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, United Kingdom
Queen Elizabeth Hospital
🇬🇧Kings Lynn, United Kingdom
St George'S Hospital; Oncology Research Office /Oncology Opd
🇬🇧London, United Kingdom
James Cook Uni Hospital
🇬🇧Middlesborough, United Kingdom
Charing Cross Hospital; Medical Oncology.
🇬🇧London, United Kingdom
Christie Hospital; Breast Cancer Research Office
🇬🇧Manchester, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Royal Preston Hosptial
🇬🇧Preston, United Kingdom
Salisbury District General Hospital; Medical Oncology Dept
🇬🇧Salisbury, United Kingdom
Oldchurch Hospital
🇬🇧Romford, United Kingdom
Royal Shrewsbury Hospitals Nhs Trust; Oncology
🇬🇧Shrewsbury, United Kingdom
Southampton General Hospital; Medical Oncology
🇬🇧Southampton, United Kingdom
Worthing Hospital; Sussex Oncology Centre, Worthing Breast Unit
🇬🇧Worthing, United Kingdom
Yeovil District Hospital; Macmillan Cancer Unit
🇬🇧Yeovil, United Kingdom
Airedale General Hospital; Oncology
🇬🇧York, United Kingdom
Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology
🇮🇹Avellino, Campania, Italy
Az. Osp. Cardarelli; Divisione Di Oncologia
🇮🇹Napoli, Campania, Italy
Ospedale S. Gennaro; Oncologia Medica
🇮🇹Napoli, Campania, Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
🇮🇹Bologna, Emilia-Romagna, Italy
Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica
🇮🇹Napoli, Campania, Italy
Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
🇮🇹Napoli, Campania, Italy
Ospedale Provinciale Santa Maria delle Croci
🇮🇹Ravenna, Emilia-Romagna, Italy
Opspedale Morgagni - Pierantoni; Dept. Di Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Centro Soc. Oncologico, Azienda Sanitaria Universitaria Integrata Trieste; CENTRO ONCOLOGICO
🇮🇹Trieste, Friuli-Venezia Giulia, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
🇮🇹Bergamo, Lombardia, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
🇮🇹Brescia, Lombardia, Italy
Ospedale Di Casalpusterlengo; Day Hospital Oncologico
🇮🇹Casalpusterlengo, Lombardia, Italy
Ospedale Valduce; Dept. Di Oncologia Medica
🇮🇹Como, Lombardia, Italy
ASST DI LECCO; Oncologia Medica
🇮🇹Lecco, Lombardia, Italy
ASST OVEST MILANESE; Oncologia Medica
🇮🇹Legnano, Lombardia, Italy
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
🇮🇹Mantova, Lombardia, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
🇮🇹Milano, Lombardia, Italy
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
🇮🇹Pavia, Lombardia, Italy
Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica
🇮🇹Pavia, Lombardia, Italy
Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.
🇮🇹Pavia, Lombardia, Italy
Ospedale Di Circolo; Centro Di Senologia
🇮🇹Varese, Lombardia, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
🇮🇹Candiolo, Piemonte, Italy
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
🇮🇹Ponderano (BI), Piemonte, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
🇮🇹Torino, Piemonte, Italy
Ospedale Sant'Anna - Uni Di Torino; Unita Di Oncologia Ginecologica
🇮🇹Torino, Piemonte, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
🇮🇹Lecce, Puglia, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
🇮🇹San Giovanni Rotondo, Puglia, Italy
A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
🇮🇹Cagliari, Sardegna, Italy
Azienda Ospedaliero Universitaria Di Sassari;Oncologia
🇮🇹Sassari, Sardegna, Italy
Centro Catanese Di Oncologia; Oncologia Medica
🇮🇹Catania, Sicilia, Italy
Az. Osp. M. Ascoli G. Di Cristina; Oncologia Medica
🇮🇹Palermo, Sicilia, Italy
La Maddalena Casa Di Cura Di Alta Specialita; Oncologia Chirurgica
🇮🇹Palermo, Sicilia, Italy
Az. Osp. ; Divisione Di Oncologia
🇮🇹Ragusa, Sicilia, Italy
USL 8 Ospedale San Donato; Oncology Endocrinology
🇮🇹Arezzo, Toscana, Italy
Ospedale Santa Maria Annunziata; Oncologia
🇮🇹Bagno a Ripoli, Toscana, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
🇮🇹Firenze, Toscana, Italy
Azienda Usl 7; Dept. Oncologico
🇮🇹Poggibonsi, Toscana, Italy
Ospedale Santa Chiara; Oncologia Medica
🇮🇹Trento, Trentino-Alto Adige, Italy
Ospedale Campo Di Marte; Dipartimento Oncologico
🇮🇹Lucca, Toscana, Italy
Az. Osp. Mariano Santo; Centro Oncologico
🇮🇹Cosenza, Calabria, Italy
Glasgow Western Infirmary; Dept of Radiotherapy
🇬🇧Glasgow, United Kingdom
Gävle sjukhus onkologkliniken
🇸🇪Gaevle, Sweden
Lanssjukhuset Ryhov; Onkologkliniken
🇸🇪Jonkoping, Sweden
St Antonius Hospital; Frauenklinik
🇩🇪Eschweiler, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
🇩🇪Freiburg, Germany
Kliniken Nordoberpfalz; Klinikum Weiden; Brustzentrum
🇩🇪Weiden, Germany
AZ Groeninge (Kennedylaan)
🇧🇪Kortrijk, Belgium
Clinique Ste-Elisabeth
🇧🇪Namur, Belgium
Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
🇦🇹Wels, Austria
HIS (Etterbeek Ixelles)
🇧🇪Bruxelles, Belgium
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
🇮🇹Chieti, Abruzzo, Italy
Lhk Klagenfurt; Abt. Für Gynäkologie
🇦🇹Klagenfurt, Austria
CHU Sart-Tilman
🇧🇪Liège, Belgium
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
🇦🇹Linz, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
🇦🇹Wien, Austria
AZ Sint Jan
🇧🇪Brugge, Belgium
AZ Nikolaas (Sint Niklaas)
🇧🇪Sint Niklaas, Belgium
Josa Andras Korhaz; Dept of Oncoradiology
🇭🇺Nyíregyháza, Hungary
Istituto Regina Elena; Oncologia Medica A
🇮🇹Roma, Lazio, Italy
Ospedale San Carlo; Day Hospital Oncologia Medica
🇮🇹Potenza, Basilicata, Italy
Az. Osp. Pugliese; Dh Oncologico
🇮🇹Catanzaro, Calabria, Italy
Ospedale Civile S. Bortolo; Divisione Di Oncologia
🇮🇹Vicenza, Veneto, Italy
Wilhelminenspital; I. Medizinische Abt.
🇦🇹Wien, Austria
Hospital Erasme; Neurologie
🇧🇪Bruxelles, Belgium
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
🇮🇹Genova, Liguria, Italy
Ospedale S. Andrea Est Felettino; Oncologia Medica
🇮🇹La Spezia, Liguria, Italy
Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
🇮🇹Rionero in Vulture, Basilicata, Italy
Ospedale S. Croce Di Fano; Servizio Oncologia
🇮🇹Fano, Marche, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
🇮🇹Roma, Lazio, Italy
Policlinico Militare Di Roma; Reparto Di Oncologia
🇮🇹Roma, Lazio, Italy