A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

NCT ID: NCT01152606

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3942 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-30
• Study Completion Date: 2016-05-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

trastuzumab [Herceptin]

Intervention Type: DRUG

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.

Interventions

trastuzumab [Herceptin]

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients who are considered candidates to receive Herceptin for this indication

Exclusion Criteria

• Patients for whom Herceptin is contraindicated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Sankt Veit an der Glan, , Austria

A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

Steyr, , Austria

Krankenanstalt Rudolfstiftung; I. Med. Abt.

Vienna, , Austria

Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

Vienna, , Austria

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

Vienna, , Austria

Wilhelminenspital; I. Medizinische Abt.

Vienna, , Austria

Lhk Vöcklabruck; Ii. Interne Abt.

Vöcklabruck, , Austria

Klinikum Kreuzschwestern Wels; Iv. Interne Abt.

Wels, , Austria

ZNA Middelheim

Antwerp, , Belgium

CH EpiCURA Site Louis Caty

Baudour, , Belgium

AZ KLINA

Brasschaat, , Belgium

AZ Sint Jan

Bruges, , Belgium

HIS (Etterbeek Ixelles)

Brussels, , Belgium

Hospital Erasme; Neurologie

Brussels, , Belgium

Cliniques Universitaires St-Luc

Brussels, , 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, , Belgium

Studienzentrum Aschaffenburg

Aschaffenburg, , Germany

Internist; Praxis Für Haemotologie & Onkologie

Bad Soden, , Germany

Brustzentrum Bassum

Bassum, , Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, , Germany

Praxis Dr. Schoenegg

Berlin, , Germany

DRK Kliniken Berlin Köpenick, Frauenklinik

Berlin, , Germany

Praxis Dr Geuther

Berlin, , Germany

Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

Bielefeld, , Germany

Medizinisches Versorgungszentrum Bonn

Bonn, , Germany

Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde

Bonn, , Germany

Gemeinschaftspraxis Für Haematologie/Onkologie

Cologne, , Germany

Uniklinik Köln; Klinik Für Frauenheilkunde

Cologne, , Germany

Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum

Donauwörth, , Germany

Onkologisches Zentrum; Oncology

Donauwörth, , Germany

St. Johannes Hospital

Dortmund, , Germany

Praxis im Elbcenter 1 in Dresden-Pieschen; Dr. med. Thomas Goehler & Dipl.-Med. Steffen Doerfel

Dresden, , Germany

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf

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 im Breisgau, , 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

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

Hamburg, , Germany

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

Hamburg, , Germany

Praxis Harburger Ring

Hamburg, , Germany

Iorc-Innovation Onkologie& Research& Consulting Gmbh; Praxis Lerchenfeld Hamburg

Hamburg, , Germany

Dres. Sigrun Müller-Hagen Mathias Bertram und Ulrich Stein

Hamburg, , Germany

SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum

Hamelin, , Germany

Diakovere Henriettenstift, Frauenklinik

Hanover, , Germany

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

Hanover, , 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

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 (Wümme), , Germany

Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

Saarbrücken, , Germany

Praxis Dr. Wagner

Saarbrücken, , Germany

Klinik Saarbrücken Ggmbh; Brustzentrum

Saarbrücken, , 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, , Germany

Semmelweis Egyetem Onkologiai Központ

Budapest, , Hungary

Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

Budapest, , Hungary

Josa Andras Korhaz; Dept of Oncoradiology

Nyíregyháza, , Hungary

Vas Megyei Markusovszky Korhaz ; Pulmonology

Szombathely, , Hungary

Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica

Chieti, Abruzzo, Italy

Ospedale Vito Fazzi; Div. Oncoematologia

Lecce, Apulia, Italy

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo, Apulia, Italy

Ospedale San Carlo; Day Hospital Oncologia Medica

Potenza, Basilicate, Italy

Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia

Rionero in Vulture, Basilicate, Italy

Az. Osp. Pugliese; Dh Oncologico

Catanzaro, Calabria, Italy

Az. Osp. Mariano Santo; Centro Oncologico

Cosenza, Calabria, Italy

Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology

Avellino, Campania, 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. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

Bologna, Emilia-Romagna, Italy

Opspedale Morgagni - Pierantoni; Dept. Di Oncologia Medica

Meldola, Emilia-Romagna, Italy

Ospedale Provinciale Santa Maria delle Croci

Ravenna, 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

Ospedale S. Maria Goretti; Divisione Di Oncologia Medica

Latina, Lazio, Italy

Ospedale San Giacomo in Augusta; Reparto Oncologia

Rome, Lazio, Italy

Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

Rome, Lazio, Italy

Azienda Complesso Ospedaliero S. Filippo Neri; Divisione Di Oncologia Medica

Rome, Lazio, Italy

Istituto Regina Elena; Oncologia Medica A

Rome, Lazio, Italy

Policlinico Militare Di Roma; Reparto Di Oncologia

Rome, Lazio, Italy

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria, Italy

Ospedale S. Andrea Est Felettino; Oncologia Medica

La Spezia, Liguria, Italy

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

Brescia, Lombardy, Italy

Ospedale Di Casalpusterlengo; Day Hospital Oncologico

Casalpusterlengo, Lombardy, Italy

Ospedale Valduce; Dept. Di Oncologia Medica

Como, Lombardy, Italy

ASST DI LECCO; Oncologia Medica

Lecco, Lombardy, Italy

ASST OVEST MILANESE; Oncologia Medica

Legnano, Lombardy, Italy

Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

Mantova, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

Milan, Lombardy, Italy

Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

Pavia, Lombardy, Italy

Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica

Pavia, Lombardy, Italy

Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.

Pavia, Lombardy, Italy

Ospedale Di Circolo; Centro Di Senologia

Varese, Lombardy, Italy

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont, Italy

Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

Ponderano (BI), Piedmont, Italy

A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

Turin, Piedmont, Italy

Ospedale Sant'Anna - Uni Di Torino; Unita Di Oncologia Ginecologica

Turin, Piedmont, Italy

A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

Cagliari, Sardinia, Italy

Azienda Ospedaliero Universitaria Di Sassari;Oncologia

Sassari, Sardinia, Italy

Centro Catanese Di Oncologia; Oncologia Medica

Catania, Sicily, Italy

Az. Osp. M. Ascoli G. Di Cristina; Oncologia Medica

Palermo, Sicily, Italy

La Maddalena Casa Di Cura Di Alta Specialita; Oncologia Chirurgica

Palermo, Sicily, Italy

Az. Osp. ; Divisione Di Oncologia

Ragusa, Sicily, Italy

Ospedale S. Croce Di Fano; Servizio Oncologia

Fano, The Marches, Italy

Ospedale Santa Chiara; Oncologia Medica

Trento, Trentino-Alto Adige, Italy

USL 8 Ospedale San Donato; Oncology Endocrinology

Arezzo, Tuscany, Italy

Ospedale Santa Maria Annunziata; Oncologia

Bagno a Ripoli, Tuscany, Italy

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, Italy

Ospedale Campo Di Marte; Dipartimento Oncologico

Lucca, Tuscany, Italy

Azienda Usl 7; Dept. Oncologico

Poggibonsi, Tuscany, Italy

Arcispedale S.Anna; Oncologia Medica

Cona (Ferrara), Veneto, Italy

Polo Ospedaliero Santorso

Santorso, Veneto, Italy

Ospedale Civile S. Bortolo; Divisione Di Oncologia

Vicenza, Veneto, Italy

Regionalne Centrum Onkologi; Oddzial Chorob Wewnetrznych I Onkologii

Bydgoszcz, , Poland

Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

Poznan, , Poland

Hospital General de Mataro; Servicio de Oncologia

Mataró, Barcelona, Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, Spain

Hospital Universitario de Canarias;servicio de Oncologia

San Cristóbal de La Laguna, Tenerife, Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, , Spain

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Seville, , Spain

Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

Toledo, , Spain

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, , Spain

Gävle sjukhus onkologkliniken

Gävle, , Sweden

Lanssjukhuset Ryhov; Onkologkliniken

Jönköping, , 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

Umeå, , 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

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

St Thomas Hospital; Medicine Div.

London, , United Kingdom

St George'S Hospital; Oncology Research Office /Oncology Opd

London, , United Kingdom

Charing Cross Hospital; Medical Oncology.

London, , United Kingdom

Christie Hospital; Breast Cancer Research Office

Manchester, , United Kingdom

James Cook Uni Hospital

Middlesbrough, , 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, , United Kingdom

Countries

Austria; Belgium; Germany; Hungary; Italy; Poland; Spain; Sweden; United Kingdom

Other Identifiers

BO20652

Identifier Type: -

Identifier Source: org_study_id