A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
1 other identifier
observational
3,942
9 countries
205
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2007
Longer than P75 for all trials
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2007
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2016
CompletedJanuary 25, 2018
January 1, 2018
8.8 years
June 28, 2010
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Cohort
Interventions
There is no planned investigational product or a treatment regimen prescribed by this protocol. Decision about a treatment regimen will be made according to the local practice and in the best interest of individual patients.
Eligibility Criteria
HER2-positive Breast Cancer
You may qualify if:
- All patients who are considered candidates to receive Herceptin for this indication
You may not qualify if:
- Patients for whom Herceptin is contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (205)
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
Graz, 8036, Austria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, 8036, Austria
Lhk Klagenfurt; Abt. Für Gynäkologie
Klagenfurt, 9026, Austria
LKH Hochsteiermark; Abt. für Innere Medizin
Leoben, 8700, Austria
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
Linz, 4010, Austria
Lhk Feldkirch; Interne Medizin Abt.
Rankweil, 6830, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
A. Ö. Krankenhaus Der Barmherzigen Brüder; Abt. Für Chirurgie
Sankt Veit an der Glan, 9300, Austria
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
Steyr, 4400, Austria
Krankenanstalt Rudolfstiftung; I. Med. Abt.
Vienna, 1030, Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, 1090, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Vienna, 1090, Austria
Wilhelminenspital; I. Medizinische Abt.
Vienna, 1160, Austria
Lhk Vöcklabruck; Ii. Interne Abt.
Vöcklabruck, 4840, Austria
Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
Wels, 4600, Austria
ZNA Middelheim
Antwerp, 2020, Belgium
CH EpiCURA Site Louis Caty
Baudour, 7331, Belgium
AZ KLINA
Brasschaat, 2930, Belgium
AZ Sint Jan
Bruges, 8000, Belgium
HIS (Etterbeek Ixelles)
Brussels, 1050, Belgium
Hospital Erasme; Neurologie
Brussels, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
AZ Groeninge (Kennedylaan)
Kortrijk, 8500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Clinique St Pierre asbl
Ottignies, 1340, Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800, Belgium
AZ Nikolaas (Sint Niklaas)
Sint-Niklaas, 9100, Belgium
AZ Turnhout Sint Elisabeth
Turnhout, 2300, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Studienzentrum Aschaffenburg
Aschaffenburg, 63739, Germany
Internist; Praxis Für Haemotologie & Onkologie
Bad Soden, 65812, Germany
Brustzentrum Bassum
Bassum, 27211, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Praxis Dr. Schoenegg
Berlin, 10719, Germany
DRK Kliniken Berlin Köpenick, Frauenklinik
Berlin, 12559, Germany
Praxis Dr Geuther
Berlin, 14195, Germany
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
Bielefeld, 33604, Germany
Medizinisches Versorgungszentrum Bonn
Bonn, 53111, Germany
Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
Bonn, 53127, Germany
Gemeinschaftspraxis Für Haematologie/Onkologie
Cologne, 50677, Germany
Uniklinik Köln; Klinik Für Frauenheilkunde
Cologne, 50931, Germany
Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
Donauwörth, 86609, Germany
Onkologisches Zentrum; Oncology
Donauwörth, 86609, Germany
St. Johannes Hospital
Dortmund, 44137, Germany
Praxis im Elbcenter 1 in Dresden-Pieschen; Dr. med. Thomas Goehler & Dipl.-Med. Steffen Doerfel
Dresden, 01127, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, 01307, Germany
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf; Frauenklinik
Düsseldorf, 40225, Germany
Kreisklinik Ebersberg; Abteilung für Gynäkologie & Geburtshilfe
Ebersberg, 85560, Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, 91054, Germany
St Antonius Hospital; Frauenklinik
Eschweiler, 52249, Germany
Uniklinik Essen; Gynäkologie
Essen, 45122, Germany
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main, 60389, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Klinikum Fulda gAG; Frauenklinik
Fulda, 36043, Germany
Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe
Georgsmarienhütte, 49124, Germany
Wilhelm-Anton-Hospital Klinik f.Hämatologie und internistische Onkologie
Goch, 47574, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, 06097, Germany
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, 20246, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, 20357, Germany
Praxis Harburger Ring
Hamburg, 21073, Germany
Iorc-Innovation Onkologie& Research& Consulting Gmbh; Praxis Lerchenfeld Hamburg
Hamburg, 22081, Germany
Dres. Sigrun Müller-Hagen Mathias Bertram und Ulrich Stein
Hamburg, 22457, Germany
SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
Hamelin, 31785, Germany
Diakovere Henriettenstift, Frauenklinik
Hanover, 30559, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625, Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
Herne, 44625, Germany
Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
Homburg/Saar, 66424, Germany
Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Jena, 07747, Germany
Westpfalz-Klinikum GmbH; Klinik für Frauenheilkunde und Geburtshilfe
Kaiserslautern, 67655, Germany
Gemeinschaftspraxis Dr. Siehl & Dr. Soeling
Kassel, 34119, Germany
Systemedic Frauenarzte Pruener Gang
Kiel, 24103, Germany
Asklepios Klinik; Abt. Gynäkologie
Langen, 63225, Germany
Klinik Lippe Lemgo; Medizinische Klinik II/Haematoonkologie
Lemgo, 32657, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, 23538, Germany
Onkologische Gemeinschaftspraxis
Magdeburg, 39104, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131, Germany
Universitätsklinikum Marburg; Gynäkologie
Marburg, 35043, Germany
Ev. Krankenhaus
Mülheim, 45468, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48149, Germany
Praxis Für Haematologie & Onkologie Dr. B. Otremba
Oldenburg, 26121, Germany
Praxis Frau Dr. Schwarz
Oranienburg, 16515, Germany
Klinikum Passau; 2. Medizinische Klinik; Onkologie und Hämatologie
Passau, 94032, Germany
Krankenhaus Rheinfelden; Frauenklinik
Rheinfelden, 79618, Germany
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), 27356, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113, Germany
Praxis Dr. Wagner
Saarbrücken, 66113, Germany
Klinik Saarbrücken Ggmbh; Brustzentrum
Saarbrücken, 66119, Germany
DRK Krankenhaus Saarlouis; Kooperatives Brustzentrum
Saarlouis, 66740, Germany
Marienkrankenhaus Abt. Gynäkologie und Geburtshilfe
Saint Wendel, 66606, Germany
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
Stade, 21680, Germany
Johanniter-Krankenhaus
Stendal, 39576, Germany
Klinik Der Hansestadt Stralsund Gmbh; Frauenklinik
Stralsund, 18435, Germany
Klinikum Traunstein
Traunstein, 83278, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, 54290, Germany
Katharinen-Hospital gGmbH
Unna, 59423, Germany
Kliniken Nordoberpfalz; Klinikum Weiden; Brustzentrum
Weiden, 92637, Germany
Gemeinschaftspraxis Hämatologie / Onkologie
Wiesbaden, 65191, Germany
Semmelweis Egyetem Onkologiai Központ
Budapest, 1083, Hungary
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
Budapest, 1145, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400, Hungary
Vas Megyei Markusovszky Korhaz ; Pulmonology
Szombathely, 9700, Hungary
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
Chieti, Abruzzo, 66100, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, 73100, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Apulia, 71013, Italy
Ospedale San Carlo; Day Hospital Oncologia Medica
Potenza, Basilicate, 85100, Italy
Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
Rionero in Vulture, Basilicate, 85028, Italy
Az. Osp. Pugliese; Dh Oncologico
Catanzaro, Calabria, 88100, Italy
Az. Osp. Mariano Santo; Centro Oncologico
Cosenza, Calabria, 87100, Italy
Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology
Avellino, Campania, 83100, Italy
Az. Osp. Cardarelli; Divisione Di Oncologia
Napoli, Campania, 80131, Italy
Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
Napoli, Campania, 80131, Italy
Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica
Napoli, Campania, 80131, Italy
Ospedale S. Gennaro; Oncologia Medica
Napoli, Campania, 80136, Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
Bologna, Emilia-Romagna, 40138, Italy
Opspedale Morgagni - Pierantoni; Dept. Di Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
Ospedale Provinciale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48100, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, 33081, Italy
Centro Soc. Oncologico, Azienda Sanitaria Universitaria Integrata Trieste; CENTRO ONCOLOGICO
Trieste, Friuli Venezia Giulia, 34100, Italy
Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
Latina, Lazio, 04100, Italy
Ospedale San Giacomo in Augusta; Reparto Oncologia
Rome, Lazio, 00100, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, 00128, Italy
Azienda Complesso Ospedaliero S. Filippo Neri; Divisione Di Oncologia Medica
Rome, Lazio, 00135, Italy
Istituto Regina Elena; Oncologia Medica A
Rome, Lazio, 00168, Italy
Policlinico Militare Di Roma; Reparto Di Oncologia
Rome, Lazio, 00184, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
Ospedale S. Andrea Est Felettino; Oncologia Medica
La Spezia, Liguria, 19100, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24128, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123, Italy
Ospedale Di Casalpusterlengo; Day Hospital Oncologico
Casalpusterlengo, Lombardy, 20071, Italy
Ospedale Valduce; Dept. Di Oncologia Medica
Como, Lombardy, 22100, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, 23900, Italy
ASST OVEST MILANESE; Oncologia Medica
Legnano, Lombardy, 20025, Italy
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
Mantova, Lombardy, 46100, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
Milan, Lombardy, 20142, Italy
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
Pavia, Lombardy, 27100, Italy
Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica
Pavia, Lombardy, 27100, Italy
Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.
Pavia, Lombardy, 27100, Italy
Ospedale Di Circolo; Centro Di Senologia
Varese, Lombardy, 21100, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piedmont, 10060, Italy
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
Ponderano (BI), Piedmont, 13875, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Turin, Piedmont, 10126, Italy
Ospedale Sant'Anna - Uni Di Torino; Unita Di Oncologia Ginecologica
Turin, Piedmont, 10126, Italy
A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
Cagliari, Sardinia, 09100, Italy
Azienda Ospedaliero Universitaria Di Sassari;Oncologia
Sassari, Sardinia, 07100, Italy
Centro Catanese Di Oncologia; Oncologia Medica
Catania, Sicily, 95126, Italy
Az. Osp. M. Ascoli G. Di Cristina; Oncologia Medica
Palermo, Sicily, 90127, Italy
La Maddalena Casa Di Cura Di Alta Specialita; Oncologia Chirurgica
Palermo, Sicily, 90146, Italy
Az. Osp. ; Divisione Di Oncologia
Ragusa, Sicily, 97100, Italy
Ospedale S. Croce Di Fano; Servizio Oncologia
Fano, The Marches, 61032, Italy
Ospedale Santa Chiara; Oncologia Medica
Trento, Trentino-Alto Adige, 38100, Italy
USL 8 Ospedale San Donato; Oncology Endocrinology
Arezzo, Tuscany, 52100, Italy
Ospedale Santa Maria Annunziata; Oncologia
Bagno a Ripoli, Tuscany, 50012, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Florence, Tuscany, 50139, Italy
Ospedale Campo Di Marte; Dipartimento Oncologico
Lucca, Tuscany, 55100, Italy
Azienda Usl 7; Dept. Oncologico
Poggibonsi, Tuscany, 53036, Italy
Arcispedale S.Anna; Oncologia Medica
Cona (Ferrara), Veneto, 44124, Italy
Polo Ospedaliero Santorso
Santorso, Veneto, 36014, Italy
Ospedale Civile S. Bortolo; Divisione Di Oncologia
Vicenza, Veneto, 36100, Italy
Regionalne Centrum Onkologi; Oddzial Chorob Wewnetrznych I Onkologii
Bydgoszcz, 85-796, Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, 60-569, Poland
Hospital General de Mataro; Servicio de Oncologia
Mataró, Barcelona, 08304, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 08208, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, 31008, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, 45004, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Gävle sjukhus onkologkliniken
Gävle, 80187, Sweden
Lanssjukhuset Ryhov; Onkologkliniken
Jönköping, 55185, Sweden
Länssjukhuset Kalmar; Oncology
Kalmar, 39185, Sweden
Centralsjukhuset Karlstad, Onkologkliniken
Karlstad, 65185, Sweden
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, 58185, Sweden
Skånes University Hospital, Skånes Department of Onclology
Lund, 22185, Sweden
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm, 17176, Sweden
Länssjukhuset Sundsvall, Onkologkliniken
Sundsvall, 85186, Sweden
Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
Umeå, 90185, Sweden
Aberdeen Royal Infirmary; Medical Oncology Dept
Aberdeen, AB25 2ZN, United Kingdom
Belfast City Hospital; Dept of Oncology
Belfast, BT9 7AB, United Kingdom
Velindre Cancer Centre; Oncology Dept
Cardiff, CF14 2TL, United Kingdom
Broomfield Hospital; Oncology
Chelmsford, CM1 7ET, United Kingdom
Ninewells Hospital; Dept of Radiotherapy & Oncology
Dundee, DD1 9SY, United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, EX2 5DW, United Kingdom
Glasgow Western Infirmary; Dept of Radiotherapy
Glasgow, G11 6NT, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
St Thomas Hospital; Medicine Div.
London, SE1 7EH, United Kingdom
St George'S Hospital; Oncology Research Office /Oncology Opd
London, SW17 ORE, United Kingdom
Charing Cross Hospital; Medical Oncology.
London, W6 8RF, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
James Cook Uni Hospital
Middlesbrough, TS4 3BW, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE, United Kingdom
Royal Preston Hosptial
Preston, PR2 9HT, United Kingdom
Oldchurch Hospital
Romford, RM7 0BE, United Kingdom
Salisbury District General Hospital; Medical Oncology Dept
Salisbury, SP2 8BJ, United Kingdom
Royal Shrewsbury Hospitals Nhs Trust; Oncology
Shrewsbury, SY3 8XQ, United Kingdom
Southampton General Hospital; Medical Oncology
Southampton, SO16 6YD, United Kingdom
Worthing Hospital; Sussex Oncology Centre, Worthing Breast Unit
Worthing, B11 2DH, United Kingdom
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, BA21 4AT, United Kingdom
Airedale General Hospital; Oncology
York, BD20 6TD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
August 30, 2007
Primary Completion
May 31, 2016
Study Completion
May 31, 2016
Last Updated
January 25, 2018
Record last verified: 2018-01