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

Breast Cancer Clinical Trial

Official title:

An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152606
• Other study ID #: BO20652
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: January 23, 2018
• Start date: August 30, 2007
• Est. completion date: May 31, 2016

Study information

• Verified date: January 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

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