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

January 23, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3942

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
      • Graz, Austria, 8036
        • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
      • Klagenfurt, Austria, 9026
        • Lhk Klagenfurt; Abt. Für Gynäkologie
      • Leoben, Austria, 8700
        • LKH Hochsteiermark; Abt. für Innere Medizin
      • Linz, Austria, 4010
        • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
      • Rankweil, Austria, 6830
        • Lhk Feldkirch; Interne Medizin Abt.
      • Salzburg, Austria, 5020
        • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
      • St Veit An Der Glan, Austria, 9300
        • A. Ö. Krankenhaus Der Barmherzigen Brüder; Abt. Für Chirurgie
      • Steyr, Austria, 4400
        • A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
      • Vöcklabruck, Austria, 4840
        • Lhk Vöcklabruck; Ii. Interne Abt.
      • Wels, Austria, 4600
        • Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
      • Wien, Austria, 1030
        • Krankenanstalt Rudolfstiftung; I. Med. Abt.
      • Wien, Austria, 1160
        • Wilhelminenspital; I. Medizinische Abt.
  • Belgium
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Baudour, Belgium, 7331
        • CH EpiCURA Site Louis Caty
      • Brasschaat, Belgium, 2930
        • AZ KLINA
      • Brugge, Belgium, 8000
        • AZ Sint Jan
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Bruxelles, Belgium, 1070
        • Hospital Erasme; Neurologie
      • Bruxelles, Belgium, 1050
        • HIS (Etterbeek Ixelles)
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Kortrijk, Belgium, 8500
        • AZ Groeninge (Kennedylaan)
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Namur, Belgium, 5000
        • Clinique Ste-Elisabeth
      • Ottignies, Belgium, 1340
        • Clinique St Pierre asbl
      • Roeselare, Belgium, 8800
        • AZ Delta (Campus Wilgenstraat)
      • Sint Niklaas, Belgium, 9100
        • AZ Nikolaas (Sint Niklaas)
      • Turnhout, Belgium, 2300
        • AZ Turnhout Sint Elisabeth
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Germany
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Aschaffenburg
      • Bad Soden, Germany, 65812
        • Internist; Praxis Für Haemotologie & Onkologie
      • Bassum, Germany, 27211
        • Brustzentrum Bassum
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Berlin, Germany, 10719
        • Praxis Dr. Schoenegg
      • Berlin, Germany, 12559
        • DRK Kliniken Berlin Köpenick, Frauenklinik
      • Berlin, Germany, 14195
        • Praxis Dr Geuther
      • Bielefeld, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
      • Bonn, Germany, 53111
        • Medizinisches Versorgungszentrum Bonn
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
      • Donauwörth, Germany, 86609
        • Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
      • Donauwörth, Germany, 86609
        • Onkologisches Zentrum; Oncology
      • Dortmund, Germany, 44137
        • St. Johannes Hospital
      • Dresden, Germany, 01127
        • Praxis im Elbcenter 1 in Dresden-Pieschen; Dr. med. Thomas Goehler & Dipl.-Med. Steffen Doerfel
      • Dresden, Germany, 01307
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf; Frauenklinik
      • Ebersberg, Germany, 85560
        • Kreisklinik Ebersberg; Abteilung für Gynäkologie & Geburtshilfe
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen; Frauenklinik
      • Eschweiler, Germany, 52249
        • St Antonius Hospital; Frauenklinik
      • Essen, Germany, 45122
        • Uniklinik Essen; Gynäkologie
      • Frankfurt am Main, Germany, 60389
        • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
      • Freiburg, Germany, 79110
        • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
      • Fulda, Germany, 36043
        • Klinikum Fulda gAG; Frauenklinik
      • Georgsmarienhütte, Germany, 49124
        • Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe
      • Goch, Germany, 47574
        • Wilhelm-Anton-Hospital Klinik f.Hämatologie und internistische Onkologie
      • Halle, Germany, 06097
        • Martin-Luther-Universität Halle-Wittenberg
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
      • Hamburg, Germany, 20357
        • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
      • Hamburg, Germany, 21073
        • Praxis Harburger Ring
      • Hamburg, Germany, 22081
        • Iorc-Innovation Onkologie& Research& Consulting Gmbh; Praxis Lerchenfeld Hamburg
      • Hamburg, Germany, 22457
        • Dres. Sigrun Müller-Hagen Mathias Bertram und Ulrich Stein
      • Hameln, Germany, 31785
        • SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
      • Hannover, Germany, 30625
        • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
      • Hannover, Germany, 30559
        • Diakovere Henriettenstift, Frauenklinik
      • Herne, Germany, 44625
        • Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
      • Homburg/Saar, Germany, 66424
        • Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
      • Jena, Germany, 07747
        • Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
      • Kaiserslautern, Germany, 67655
        • Westpfalz-Klinikum GmbH; Klinik für Frauenheilkunde und Geburtshilfe
      • Kassel, Germany, 34119
        • Gemeinschaftspraxis Dr. Siehl & Dr. Soeling
      • Kiel, Germany, 24103
        • Systemedic Frauenarzte Pruener Gang
      • Köln, Germany, 50677
        • Gemeinschaftspraxis Für Haematologie/Onkologie
      • Köln, Germany, 50931
        • Uniklinik Köln; Klinik Für Frauenheilkunde
      • Langen, Germany, 63225
        • Asklepios Klinik; Abt. Gynäkologie
      • Lemgo, Germany, 32657
        • Klinik Lippe Lemgo; Medizinische Klinik II/Haematoonkologie
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
      • Magdeburg, Germany, 39104
        • Onkologische Gemeinschaftspraxis
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
      • Marburg, Germany, 35043
        • Universitätsklinikum Marburg; Gynäkologie
      • Mülheim, Germany, 45468
        • Ev. Krankenhaus
      • Münster, Germany, 48149
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Oldenburg, Germany, 26121
        • Praxis Für Haematologie & Onkologie Dr. B. Otremba
      • Oranienburg, Germany, 16515
        • Praxis Frau Dr. Schwarz
      • Passau, Germany, 94032
        • Klinikum Passau; 2. Medizinische Klinik; Onkologie und Hämatologie
      • Rheinfelden, Germany, 79618
        • Krankenhaus Rheinfelden; Frauenklinik
      • Rotenburg-wuemme, Germany, 27356
        • Agaplesion Diakonieklinikum Rotenburg
      • Saarbruecken, Germany, 66113
        • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
      • Saarbruecken, Germany, 66113
        • Praxis Dr. Wagner
      • Saarbruecken, Germany, 66119
        • Klinik Saarbrücken Ggmbh; Brustzentrum
      • Saarlouis, Germany, 66740
        • DRK Krankenhaus Saarlouis; Kooperatives Brustzentrum
      • Saint Wendel, Germany, 66606
        • Marienkrankenhaus Abt. Gynäkologie und Geburtshilfe
      • Stade, Germany, 21680
        • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
      • Stendal, Germany, 39576
        • Johanniter-Krankenhaus
      • Stralsund, Germany, 18435
        • Klinik Der Hansestadt Stralsund Gmbh; Frauenklinik
      • Traunstein, Germany, 83278
        • Klinikum Traunstein
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
      • Unna, Germany, 59423
        • Katharinen-Hospital gGmbH
      • Weiden, Germany, 92637
        • Kliniken Nordoberpfalz; Klinikum Weiden; Brustzentrum
      • Wiesbaden, Germany, 65191
        • Gemeinschaftspraxis Hämatologie / Onkologie
  • Hungary
      • Budapest, Hungary, 1145
        • Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem Onkologiai Központ
      • Nyíregyháza, Hungary, 4400
        • Josa Andras Korhaz; Dept of Oncoradiology
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Korhaz ; Pulmonology
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
        • Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
    • Basilicata
      • Potenza, Basilicata, Italy, 85100
        • Ospedale San Carlo; Day Hospital Oncologia Medica
      • Rionero in Vulture, Basilicata, Italy, 85028
        • Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Az. Osp. Pugliese; Dh Oncologico
      • Cosenza, Calabria, Italy, 87100
        • Az. Osp. Mariano Santo; Centro Oncologico
    • Campania
      • Avellino, Campania, Italy, 83100
        • Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology
      • Napoli, Campania, Italy, 80131
        • Az. Osp. Cardarelli; Divisione Di Oncologia
      • Napoli, Campania, Italy, 80131
        • Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
      • Napoli, Campania, Italy, 80131
        • Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica
      • Napoli, Campania, Italy, 80136
        • Ospedale S. Gennaro; Oncologia Medica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
      • Meldola, Emilia-Romagna, Italy, 47014
        • Opspedale Morgagni - Pierantoni; Dept. Di Oncologia Medica
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Ospedale Provinciale Santa Maria Delle Croci
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
      • Trieste, Friuli-Venezia Giulia, Italy, 34100
        • Centro Soc. Oncologico, Azienda Sanitaria Universitaria Integrata Trieste; CENTRO ONCOLOGICO
    • Lazio
      • Latina, Lazio, Italy, 04100
        • Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
      • Roma, Lazio, Italy, 00100
        • Ospedale San Giacomo in Augusta; Reparto Oncologia
      • Roma, Lazio, Italy, 00135
        • Azienda Complesso Ospedaliero S. Filippo Neri; Divisione Di Oncologia Medica
      • Roma, Lazio, Italy, 00168
        • Istituto Regina Elena; Oncologia Medica A
      • Roma, Lazio, Italy, 00184
        • Policlinico Militare Di Roma; Reparto Di Oncologia
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
      • La Spezia, Liguria, Italy, 19100
        • Ospedale S. Andrea Est Felettino; Oncologia Medica
    • Lombardia
      • Bergamo, Lombardia, Italy, 24128
        • Asst Papa Giovanni XXIII; Oncologia Medica
      • Brescia, Lombardia, Italy, 25123
        • Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
      • Casalpusterlengo, Lombardia, Italy, 20071
        • Ospedale Di Casalpusterlengo; Day Hospital Oncologico
      • Como, Lombardia, Italy, 22100
        • Ospedale Valduce; Dept. Di Oncologia Medica
      • Lecco, Lombardia, Italy, 23900
        • ASST DI LECCO; Oncologia Medica
      • Legnano, Lombardia, Italy, 20025
        • ASST OVEST MILANESE; Oncologia Medica
      • Mantova, Lombardia, Italy, 46100
        • Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Lombardia, Italy, 20142
        • Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
      • Pavia, Lombardia, Italy, 27100
        • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
      • Pavia, Lombardia, Italy, 27100
        • Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica
      • Pavia, Lombardia, Italy, 27100
        • Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.
      • Varese, Lombardia, Italy, 21100
        • Ospedale Di Circolo; Centro Di Senologia
    • Marche
      • Fano, Marche, Italy, 61032
        • Ospedale S. Croce Di Fano; Servizio Oncologia
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
        • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
      • Ponderano (BI), Piemonte, Italy, 13875
        • Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
      • Torino, Piemonte, Italy, 10126
        • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
      • Torino, Piemonte, Italy, 10126
        • Ospedale Sant'Anna - Uni Di Torino; Unita Di Oncologia Ginecologica
    • Puglia
      • Lecce, Puglia, Italy, 73100
        • Ospedale Vito Fazzi; Div. Oncoematologia
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
    • Sardegna
      • Cagliari, Sardegna, Italy, 09100
        • A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
      • Sassari, Sardegna, Italy, 07100
        • Azienda Ospedaliero Universitaria Di Sassari;Oncologia
    • Sicilia
      • Catania, Sicilia, Italy, 95126
        • Centro Catanese Di Oncologia; Oncologia Medica
      • Palermo, Sicilia, Italy, 90127
        • Az. Osp. M. Ascoli G. Di Cristina; Oncologia Medica
      • Palermo, Sicilia, Italy, 90146
        • La Maddalena Casa Di Cura Di Alta Specialita; Oncologia Chirurgica
      • Ragusa, Sicilia, Italy, 97100
        • Az. Osp. ; Divisione Di Oncologia
    • Toscana
      • Arezzo, Toscana, Italy, 52100
        • USL 8 Ospedale San Donato; Oncology Endocrinology
      • Bagno a Ripoli, Toscana, Italy, 50012
        • Ospedale Santa Maria Annunziata; Oncologia
      • Firenze, Toscana, Italy, 50139
        • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
      • Lucca, Toscana, Italy, 55100
        • Ospedale Campo Di Marte; Dipartimento Oncologico
      • Poggibonsi, Toscana, Italy, 53036
        • Azienda Usl 7; Dept. Oncologico
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38100
        • Ospedale Santa Chiara; Oncologia Medica
    • Veneto
      • Cona (Ferrara), Veneto, Italy, 44124
        • Arcispedale S.Anna; Oncologia Medica
      • Santorso, Veneto, Italy, 36014
        • Polo Ospedaliero Santorso
      • Vicenza, Veneto, Italy, 36100
        • Ospedale Civile S. Bortolo; Divisione Di Oncologia
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Regionalne Centrum Onkologi; Oddzial Chorob Wewnetrznych I Onkologii
      • Poznan, Poland, 60-569
        • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
  • Spain
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Navarra, Spain, 31008
        • Hospital de Navarra; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet; Servicio Oncologia
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Hospital General de Mataro; Servicio de Oncologia
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias;servicio de Oncologia
  • Sweden
      • Gaevle, Sweden, 80187
        • Gävle Sjukhus Onkologkliniken
      • Jonkoping, Sweden, 55185
        • Lanssjukhuset Ryhov; Onkologkliniken
      • Kalmar, Sweden, 39185
        • Länssjukhuset Kalmar; Oncology
      • Karlstad, Sweden, 65185
        • Centralsjukhuset Karlstad, Onkologkliniken
      • Linköping, Sweden, 58185
        • Uni Hospital Linkoeping; Dept. of Oncology
      • Lund, Sweden, 22185
        • Skånes University Hospital, Skånes Department of Onclology
      • Stockholm, Sweden, 17176
        • Karolinska Hospital; Oncology - Radiumhemmet
      • Sundsvall, Sweden, 85186
        • Länssjukhuset Sundsvall, Onkologkliniken
      • Umea, Sweden, 90185
        • Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary; Medical Oncology Dept
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital; Dept of Oncology
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre; Oncology Dept
      • Chelmsford, United Kingdom, CM1 7ET
        • Broomfield Hospital; Oncology
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital; Dept of Radiotherapy & Oncology
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital; Oncology Centre
      • Glasgow, United Kingdom, G11 6NT
        • Glasgow Western Infirmary; Dept of Radiotherapy
      • Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Kings Lynn, United Kingdom, PE30 4ET
        • Queen Elizabeth Hospital
      • London, United Kingdom, SW17 ORE
        • St George'S Hospital; Oncology Research Office /Oncology Opd
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital; Medicine Div.
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital; Medical Oncology.
      • Manchester, United Kingdom, M20 4QL
        • Christie Hospital; Breast Cancer Research Office
      • Middlesborough, United Kingdom, TS4 3BW
        • James Cook Uni Hospital
      • Newcastle Upon Tyne, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hosptial
      • Romford, United Kingdom, RM7 0BE
        • Oldchurch Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury District General Hospital; Medical Oncology Dept
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospitals Nhs Trust; Oncology
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital; Medical Oncology
      • Worthing, United Kingdom, B11 2DH
        • Worthing Hospital; Sussex Oncology Centre, Worthing Breast Unit
      • Yeovil, United Kingdom, BA21 4AT
        • Yeovil District Hospital; Macmillan Cancer Unit
      • York, United Kingdom, BD20 6TD
        • Airedale General Hospital; Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HER2-positive Breast Cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients for whom Herceptin is contraindicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death
Time Frame: On treatment and up to 5 years follow-up
On treatment and up to 5 years follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset and the time to recovery of symptomatic congestive heart failure
Time Frame: On treatment and up to 5 years follow-up
On treatment and up to 5 years follow-up
Incidence of asymptomatic cardiac failure and other significant cardiac conditions
Time Frame: On treatment and up to 5 years follow-up
On treatment and up to 5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2007

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

May 31, 2016

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO20652

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

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