Breast Cancer Clinical Trial
Official title:
An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
| Verified date | January 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 3942 |
| Est. completion date | May 31, 2016 |
| Est. primary completion date | May 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients who are considered candidates to receive Herceptin for this indication Exclusion Criteria: - Patients for whom Herceptin is contraindicated |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie | Graz | |
| Austria | LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | Graz | |
| Austria | Lhk Klagenfurt; Abt. Für Gynäkologie | Klagenfurt | |
| Austria | LKH Hochsteiermark; Abt. für Innere Medizin | Leoben | |
| Austria | Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1 | Linz | |
| Austria | Lhk Feldkirch; Interne Medizin Abt. | Rankweil | |
| Austria | Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | |
| 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 | Klinikum Kreuzschwestern Wels; Iv. Interne Abt. | Wels | |
| Austria | Krankenanstalt Rudolfstiftung; I. Med. Abt. | Wien | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Wien | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Innere Medizin I | Wien | |
| Austria | Wilhelminenspital; I. Medizinische Abt. | Wien | |
| Belgium | ZNA Middelheim | Antwerpen | |
| Belgium | CH EpiCURA Site Louis Caty | Baudour | |
| Belgium | AZ KLINA | Brasschaat | |
| Belgium | AZ Sint Jan | Brugge | |
| Belgium | Cliniques Universitaires St-Luc | Bruxelles | |
| Belgium | HIS (Etterbeek Ixelles) | Bruxelles | |
| Belgium | Hospital Erasme; Neurologie | Bruxelles | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | AZ Groeninge (Kennedylaan) | Kortrijk | |
| Belgium | CHU Sart-Tilman | Liège | |
| Belgium | Clinique Ste-Elisabeth | Namur | |
| Belgium | Clinique St Pierre asbl | Ottignies | |
| Belgium | AZ Delta (Campus Wilgenstraat) | Roeselare | |
| Belgium | AZ Nikolaas (Sint Niklaas) | Sint Niklaas | |
| Belgium | AZ Turnhout Sint Elisabeth | Turnhout | |
| Belgium | Sint Augustinus Wilrijk | Wilrijk | |
| Germany | Studienzentrum Aschaffenburg | Aschaffenburg | |
| Germany | Internist; Praxis Für Haemotologie & Onkologie | Bad Soden | |
| Germany | Brustzentrum Bassum | Bassum | |
| Germany | DRK Kliniken Berlin Köpenick, Frauenklinik | Berlin | |
| Germany | Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | |
| Germany | Praxis Dr Geuther | Berlin | |
| Germany | Praxis Dr. Schoenegg | Berlin | |
| Germany | Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie | Bielefeld | |
| Germany | Medizinisches Versorgungszentrum Bonn | Bonn | |
| Germany | Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde | Bonn | |
| Germany | Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum | Donauwörth | |
| Germany | Onkologisches Zentrum; Oncology | Donauwörth | |
| Germany | St. Johannes Hospital | Dortmund | |
| Germany | BAG Freiberg-Richter, Jacobasch, Illmer, Wolf | Dresden | |
| Germany | Praxis im Elbcenter 1 in Dresden-Pieschen; Dr. med. Thomas Goehler & Dipl.-Med. Steffen Doerfel | Dresden | |
| Germany | Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe | Dresden | |
| Germany | Universitätsklinikum Düsseldorf; Frauenklinik | Düsseldorf | |
| Germany | Kreisklinik Ebersberg; Abteilung für Gynäkologie & Geburtshilfe | Ebersberg | |
| Germany | Universitätsklinikum Erlangen; Frauenklinik | Erlangen | |
| Germany | St Antonius Hospital; Frauenklinik | Eschweiler | |
| Germany | Uniklinik Essen; Gynäkologie | Essen | |
| Germany | Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus | Frankfurt am Main | |
| Germany | Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg | |
| Germany | Klinikum Fulda gAG; Frauenklinik | Fulda | |
| 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 | Martin-Luther-Universität Halle-Wittenberg | Halle | |
| Germany | Dres. Sigrun Müller-Hagen Mathias Bertram und Ulrich Stein | Hamburg | |
| Germany | Iorc-Innovation Onkologie& Research& Consulting Gmbh; Praxis Lerchenfeld Hamburg | Hamburg | |
| Germany | Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem | Hamburg | |
| Germany | Praxis Harburger Ring | Hamburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf; Frauenklinik | Hamburg | |
| Germany | SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum | Hameln | |
| Germany | Diakovere Henriettenstift, Frauenklinik | Hannover | |
| Germany | Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie | Hannover | |
| Germany | Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik | Herne | |
| Germany | Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe | Homburg/Saar | |
| Germany | Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin | Jena | |
| Germany | Westpfalz-Klinikum GmbH; Klinik für Frauenheilkunde und Geburtshilfe | Kaiserslautern | |
| 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 | Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde | Mainz | |
| Germany | Universitätsklinikum Marburg; Gynäkologie | Marburg | |
| Germany | Ev. Krankenhaus | Mülheim | |
| Germany | Gemeinschaftspraxis für Hämatologie und Onkologie | Münster | |
| 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 | Krankenhaus Rheinfelden; Frauenklinik | Rheinfelden | |
| Germany | Agaplesion Diakonieklinikum Rotenburg | Rotenburg-wuemme | |
| 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 | Johanniter-Krankenhaus | Stendal | |
| Germany | Klinik Der Hansestadt Stralsund Gmbh; Frauenklinik | Stralsund | |
| Germany | Klinikum Traunstein | Traunstein | |
| Germany | Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie | Trier | |
| Germany | Katharinen-Hospital gGmbH | Unna | |
| Germany | Kliniken Nordoberpfalz; Klinikum Weiden; Brustzentrum | Weiden | |
| Germany | Gemeinschaftspraxis Hämatologie / Onkologie | Wiesbaden | |
| Hungary | Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology | Budapest | |
| Hungary | Semmelweis Egyetem Onkologiai Központ | Budapest | |
| Hungary | Josa Andras Korhaz; Dept of Oncoradiology | Nyíregyháza | |
| Hungary | Vas Megyei Markusovszky Korhaz ; Pulmonology | Szombathely | |
| Italy | USL 8 Ospedale San Donato; Oncology Endocrinology | Arezzo | Toscana |
| Italy | Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology | Avellino | Campania |
| Italy | Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli-Venezia Giulia |
| Italy | Ospedale Santa Maria Annunziata; Oncologia | Bagno a Ripoli | Toscana |
| Italy | Asst Papa Giovanni XXIII; Oncologia Medica | Bergamo | Lombardia |
| Italy | Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli | Bologna | Emilia-Romagna |
| Italy | Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardia |
| Italy | A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia | Cagliari | Sardegna |
| Italy | Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico | Candiolo | Piemonte |
| Italy | Ospedale Di Casalpusterlengo; Day Hospital Oncologico | Casalpusterlengo | Lombardia |
| Italy | Centro Catanese Di Oncologia; Oncologia Medica | Catania | Sicilia |
| Italy | Az. Osp. Pugliese; Dh Oncologico | Catanzaro | Calabria |
| Italy | Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica | Chieti | Abruzzo |
| Italy | Ospedale Valduce; Dept. Di Oncologia Medica | Como | Lombardia |
| Italy | Arcispedale S.Anna; Oncologia Medica | Cona (Ferrara) | Veneto |
| Italy | Az. Osp. Mariano Santo; Centro Oncologico | Cosenza | Calabria |
| Italy | Ospedale S. Croce Di Fano; Servizio Oncologia | Fano | Marche |
| Italy | Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1 | Firenze | Toscana |
| Italy | 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 S. Maria Goretti; Divisione Di Oncologia Medica | Latina | Lazio |
| Italy | Ospedale Vito Fazzi; Div. Oncoematologia | Lecce | Puglia |
| Italy | ASST DI LECCO; Oncologia Medica | Lecco | Lombardia |
| Italy | ASST OVEST MILANESE; Oncologia Medica | Legnano | Lombardia |
| Italy | Ospedale Campo Di Marte; Dipartimento Oncologico | Lucca | Toscana |
| Italy | Az. Osp. Carlo Poma; Divisione Di Oncologia Medica | Mantova | Lombardia |
| Italy | Opspedale Morgagni - Pierantoni; Dept. Di Oncologia Medica | Meldola | Emilia-Romagna |
| Italy | Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica | Milano | Lombardia |
| Italy | Istituto Europeo Di Oncologia | Milano | Lombardia |
| Italy | Az. Osp. Cardarelli; Divisione Di Oncologia | Napoli | Campania |
| Italy | Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna | Napoli | Campania |
| Italy | Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica | Napoli | Campania |
| Italy | Ospedale S. Gennaro; Oncologia Medica | Napoli | Campania |
| 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 | 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 | Azienda Usl 7; Dept. Oncologico | Poggibonsi | Toscana |
| Italy | Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica | Ponderano (BI) | Piemonte |
| Italy | Ospedale San Carlo; Day Hospital Oncologia Medica | Potenza | Basilicata |
| Italy | Az. Osp. ; Divisione Di Oncologia | Ragusa | Sicilia |
| Italy | Ospedale Provinciale Santa Maria delle Croci | Ravenna | Emilia-Romagna |
| Italy | Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia | Rionero in Vulture | Basilicata |
| Italy | Azienda Complesso Ospedaliero S. Filippo Neri; Divisione Di Oncologia Medica | Roma | Lazio |
| Italy | Istituto Regina Elena; Oncologia Medica A | Roma | Lazio |
| Italy | Ospedale San Giacomo in Augusta; Reparto Oncologia | Roma | Lazio |
| Italy | Policlinico Militare Di Roma; Reparto Di Oncologia | Roma | Lazio |
| Italy | Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica | Roma | Lazio |
| Italy | IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia | San Giovanni Rotondo | Puglia |
| Italy | Polo Ospedaliero Santorso | Santorso | Veneto |
| Italy | Azienda Ospedaliero Universitaria Di Sassari;Oncologia | Sassari | Sardegna |
| 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 Santa Chiara; Oncologia Medica | Trento | Trentino-Alto Adige |
| Italy | Centro Soc. Oncologico, Azienda Sanitaria Universitaria Integrata Trieste; CENTRO ONCOLOGICO | Trieste | Friuli-Venezia Giulia |
| Italy | Ospedale Di Circolo; Centro Di Senologia | Varese | Lombardia |
| Italy | Ospedale Civile S. Bortolo; Divisione Di Oncologia | Vicenza | Veneto |
| Poland | Regionalne Centrum Onkologi; Oddzial Chorob Wewnetrznych I Onkologii | Bydgoszcz | |
| Poland | Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu | Poznan | |
| Spain | Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaen | |
| Spain | Hospital Universitario de Canarias;servicio de Oncologia | La Laguna | Tenerife |
| Spain | Hospital Regional Universitario Carlos Haya | Malaga | |
| Spain | Hospital General de Mataro; Servicio de Oncologia | Mataro | Barcelona |
| Spain | Hospital de Navarra; Servicio de Oncologia | Navarra | |
| Spain | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona |
| Spain | Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Sevilla | |
| Spain | Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia | Toledo | |
| Spain | Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | |
| Sweden | Gävle sjukhus onkologkliniken | Gaevle | |
| Sweden | Lanssjukhuset Ryhov; Onkologkliniken | Jonkoping | |
| Sweden | Länssjukhuset Kalmar; Oncology | Kalmar | |
| Sweden | Centralsjukhuset Karlstad, Onkologkliniken | Karlstad | |
| Sweden | Uni Hospital Linkoeping; Dept. of Oncology | Linköping | |
| 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 | |
| United Kingdom | 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 | Broomfield Hospital; Oncology | Chelmsford | |
| United Kingdom | Ninewells Hospital; Dept of Radiotherapy & Oncology | Dundee | |
| United Kingdom | Royal Devon & Exeter Hospital; Oncology Centre | Exeter | |
| United Kingdom | Glasgow Western Infirmary; Dept of Radiotherapy | Glasgow | |
| United Kingdom | Huddersfield Royal Infirmary | Huddersfield | |
| United Kingdom | Queen Elizabeth Hospital | Kings Lynn | |
| United Kingdom | Charing Cross Hospital; Medical Oncology. | London | |
| United Kingdom | St George'S Hospital; Oncology Research Office /Oncology Opd | London | |
| United Kingdom | St Thomas Hospital; Medicine Div. | London | |
| United Kingdom | Christie Hospital; Breast Cancer Research Office | Manchester | |
| United Kingdom | James Cook Uni Hospital | Middlesborough | |
| United Kingdom | Newcastle General Hospital | Newcastle Upon Tyne | |
| United Kingdom | Royal Preston Hosptial | Preston | |
| United Kingdom | Oldchurch Hospital | Romford | |
| United Kingdom | Salisbury District General Hospital; Medical Oncology Dept | Salisbury | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Austria, Belgium, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Time to onset and the time to recovery of symptomatic congestive heart failure | On treatment and up to 5 years follow-up | ||
| Secondary | Incidence of asymptomatic cardiac failure and other significant cardiac conditions | On treatment and up to 5 years follow-up |
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