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AzTrials

Breast CancerNCT01152606

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

An observational study of Breast Cancer, run by Hoffmann-La Roche at 205 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab [Herceptin]
How many people
3,942 participants
Where
205 sitesin 9 countries
Study dates
30 Aug 2007to 31 May 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HER2-positive Breast Cancer

Who may be able to join

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

Who cannot join

  • Patients for whom Herceptin is contraindicated

Trial locations and contacts

205 sites in 9 countries.

205 sites in 9 countries

Germany69 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • Internist; Praxis Für Haemotologie & Onkologie

    Bad Soden, 65812

  • Brustzentrum Bassum

    Bassum, 27211

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Praxis Dr. Schoenegg

    Berlin, 10719

  • DRK Kliniken Berlin Köpenick, Frauenklinik

    Berlin, 12559

  • Praxis Dr Geuther

    Berlin, 14195

  • Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

    Bielefeld, 33604

  • Medizinisches Versorgungszentrum Bonn

    Bonn, 53111

  • Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde

    Bonn, 53127

  • Gemeinschaftspraxis Für Haematologie/Onkologie

    Cologne, 50677

  • Uniklinik Köln; Klinik Für Frauenheilkunde

    Cologne, 50931

  • Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum

    Donauwörth, 86609

  • Onkologisches Zentrum; Oncology

    Donauwörth, 86609

  • St. Johannes Hospital

    Dortmund, 44137

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

    Dresden, 01127

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, 01307

  • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

    Dresden, 01307

  • Universitätsklinikum Düsseldorf; Frauenklinik

    Düsseldorf, 40225

  • Kreisklinik Ebersberg; Abteilung für Gynäkologie & Geburtshilfe

    Ebersberg, 85560

  • Universitätsklinikum Erlangen; Frauenklinik

    Erlangen, 91054

  • St Antonius Hospital; Frauenklinik

    Eschweiler, 52249

  • Uniklinik Essen; Gynäkologie

    Essen, 45122

  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

    Frankfurt am Main, 60389

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Klinikum Fulda gAG; Frauenklinik

    Fulda, 36043

  • Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe

    Georgsmarienhütte, 49124

  • Wilhelm-Anton-Hospital Klinik f.Hämatologie und internistische Onkologie

    Goch, 47574

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06097

  • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

    Hamburg, 20246

  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

    Hamburg, 20357

  • Praxis Harburger Ring

    Hamburg, 21073

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

    Hamburg, 22081

  • Dres. Sigrun Müller-Hagen Mathias Bertram und Ulrich Stein

    Hamburg, 22457

  • SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum

    Hamelin, 31785

  • Diakovere Henriettenstift, Frauenklinik

    Hanover, 30559

  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

    Hanover, 30625

  • Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik

    Herne, 44625

  • Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

    Homburg/Saar, 66424

  • Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

    Jena, 07747

  • Westpfalz-Klinikum GmbH; Klinik für Frauenheilkunde und Geburtshilfe

    Kaiserslautern, 67655

  • Gemeinschaftspraxis Dr. Siehl & Dr. Soeling

    Kassel, 34119

  • Systemedic Frauenarzte Pruener Gang

    Kiel, 24103

  • Asklepios Klinik; Abt. Gynäkologie

    Langen, 63225

  • Klinik Lippe Lemgo; Medizinische Klinik II/Haematoonkologie

    Lemgo, 32657

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • Onkologische Gemeinschaftspraxis

    Magdeburg, 39104

  • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

    Mainz, 55131

  • Universitätsklinikum Marburg; Gynäkologie

    Marburg, 35043

  • Ev. Krankenhaus

    Mülheim, 45468

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48149

  • Praxis Für Haematologie & Onkologie Dr. B. Otremba

    Oldenburg, 26121

  • Praxis Frau Dr. Schwarz

    Oranienburg, 16515

  • Klinikum Passau; 2. Medizinische Klinik; Onkologie und Hämatologie

    Passau, 94032

  • Krankenhaus Rheinfelden; Frauenklinik

    Rheinfelden, 79618

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme), 27356

  • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

    Saarbrücken, 66113

  • Praxis Dr. Wagner

    Saarbrücken, 66113

  • Klinik Saarbrücken Ggmbh; Brustzentrum

    Saarbrücken, 66119

  • DRK Krankenhaus Saarlouis; Kooperatives Brustzentrum

    Saarlouis, 66740

  • Marienkrankenhaus Abt. Gynäkologie und Geburtshilfe

    Saint Wendel, 66606

  • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

    Stade, 21680

  • Johanniter-Krankenhaus

    Stendal, 39576

  • Klinik Der Hansestadt Stralsund Gmbh; Frauenklinik

    Stralsund, 18435

  • Klinikum Traunstein

    Traunstein, 83278

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

    Trier, 54290

  • Katharinen-Hospital gGmbH

    Unna, 59423

  • Kliniken Nordoberpfalz; Klinikum Weiden; Brustzentrum

    Weiden, 92637

  • Gemeinschaftspraxis Hämatologie / Onkologie

    Wiesbaden, 65191

Other trials in Germany

Italy58 sites

  • USL 8 Ospedale San Donato; Oncology Endocrinology

    Arezzo, Tuscany, 52100

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

    Avellino, Campania, 83100

  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

    Aviano, Friuli Venezia Giulia, 33081

  • Ospedale Santa Maria Annunziata; Oncologia

    Bagno a Ripoli, Tuscany, 50012

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24128

  • Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

    Bologna, Emilia-Romagna, 40138

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

    Brescia, Lombardy, 25123

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

    Cagliari, Sardinia, 09100

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

    Candiolo, Piedmont, 10060

  • Ospedale Di Casalpusterlengo; Day Hospital Oncologico

    Casalpusterlengo, Lombardy, 20071

  • Centro Catanese Di Oncologia; Oncologia Medica

    Catania, Sicily, 95126

  • Az. Osp. Pugliese; Dh Oncologico

    Catanzaro, Calabria, 88100

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

    Chieti, Abruzzo, 66100

  • Ospedale Valduce; Dept. Di Oncologia Medica

    Como, Lombardy, 22100

  • Arcispedale S.Anna; Oncologia Medica

    Cona (Ferrara), Veneto, 44124

  • Az. Osp. Mariano Santo; Centro Oncologico

    Cosenza, Calabria, 87100

  • Ospedale S. Croce Di Fano; Servizio Oncologia

    Fano, The Marches, 61032

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

    Florence, Tuscany, 50139

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

    Genoa, Liguria, 16132

  • Ospedale S. Andrea Est Felettino; Oncologia Medica

    La Spezia, Liguria, 19100

  • Ospedale S. Maria Goretti; Divisione Di Oncologia Medica

    Latina, Lazio, 04100

  • Ospedale Vito Fazzi; Div. Oncoematologia

    Lecce, Apulia, 73100

  • ASST DI LECCO; Oncologia Medica

    Lecco, Lombardy, 23900

  • ASST OVEST MILANESE; Oncologia Medica

    Legnano, Lombardy, 20025

  • Ospedale Campo Di Marte; Dipartimento Oncologico

    Lucca, Tuscany, 55100

  • Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

    Mantua, Lombardy, 46100

  • Opspedale Morgagni - Pierantoni; Dept. Di Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

    Milan, Lombardy, 20142

  • Az. Osp. Cardarelli; Divisione Di Oncologia

    Naples, Campania, 80131

  • Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna

    Naples, Campania, 80131

  • Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica

    Naples, Campania, 80131

  • Ospedale S. Gennaro; Oncologia Medica

    Naples, Campania, 80136

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

    Palermo, Sicily, 90127

  • La Maddalena Casa Di Cura Di Alta Specialita; Oncologia Chirurgica

    Palermo, Sicily, 90146

  • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

    Pavia, Lombardy, 27100

  • Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica

    Pavia, Lombardy, 27100

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

    Pavia, Lombardy, 27100

  • Azienda Usl 7; Dept. Oncologico

    Poggibonsi, Tuscany, 53036

  • Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

    Ponderano (BI), Piedmont, 13875

  • Ospedale San Carlo; Day Hospital Oncologia Medica

    Potenza, Basilicate, 85100

  • Az. Osp. ; Divisione Di Oncologia

    Ragusa, Sicily, 97100

  • Ospedale Provinciale Santa Maria delle Croci

    Ravenna, Emilia-Romagna, 48100

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

    Rionero in Vulture, Basilicate, 85028

  • Ospedale San Giacomo in Augusta; Reparto Oncologia

    Rome, Lazio, 00100

  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

    Rome, Lazio, 00128

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

    Rome, Lazio, 00135

  • Istituto Regina Elena; Oncologia Medica A

    Rome, Lazio, 00168

  • Policlinico Militare Di Roma; Reparto Di Oncologia

    Rome, Lazio, 00184

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

    San Giovanni Rotondo, Apulia, 71013

  • Polo Ospedaliero Santorso

    Santorso, Veneto, 36014

  • Azienda Ospedaliero Universitaria Di Sassari;Oncologia

    Sassari, Sardinia, 07100

  • Ospedale Santa Chiara; Oncologia Medica

    Trento, Trentino-Alto Adige, 38100

  • Centro Soc. Oncologico, Azienda Sanitaria Universitaria Integrata Trieste; CENTRO ONCOLOGICO

    Trieste, Friuli Venezia Giulia, 34100

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

    Turin, Piedmont, 10126

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

    Turin, Piedmont, 10126

  • Ospedale Di Circolo; Centro Di Senologia

    Varese, Lombardy, 21100

  • Ospedale Civile S. Bortolo; Divisione Di Oncologia

    Vicenza, Veneto, 36100

Other trials in Italy

United Kingdom23 sites

  • Aberdeen Royal Infirmary; Medical Oncology Dept

    Aberdeen, AB25 2ZN

  • Belfast City Hospital; Dept of Oncology

    Belfast, BT9 7AB

  • Velindre Cancer Centre; Oncology Dept

    Cardiff, CF14 2TL

  • Broomfield Hospital; Oncology

    Chelmsford, CM1 7ET

  • Ninewells Hospital; Dept of Radiotherapy & Oncology

    Dundee, DD1 9SY

  • Royal Devon & Exeter Hospital; Oncology Centre

    Exeter, EX2 5DW

  • Glasgow Western Infirmary; Dept of Radiotherapy

    Glasgow, G11 6NT

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Queen Elizabeth Hospital

    Kings Lynn, PE30 4ET

  • St Thomas Hospital; Medicine Div.

    London, SE1 7EH

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

    London, SW17 ORE

  • Charing Cross Hospital; Medical Oncology.

    London, W6 8RF

  • Christie Hospital; Breast Cancer Research Office

    Manchester, M20 4QL

  • James Cook Uni Hospital

    Middlesbrough, TS4 3BW

  • Newcastle General Hospital

    Newcastle upon Tyne, NE4 6BE

  • Royal Preston Hosptial

    Preston, PR2 9HT

  • Oldchurch Hospital

    Romford, RM7 0BE

  • Salisbury District General Hospital; Medical Oncology Dept

    Salisbury, SP2 8BJ

  • Royal Shrewsbury Hospitals Nhs Trust; Oncology

    Shrewsbury, SY3 8XQ

  • Southampton General Hospital; Medical Oncology

    Southampton, SO16 6YD

  • Worthing Hospital; Sussex Oncology Centre, Worthing Breast Unit

    Worthing, B11 2DH

  • Yeovil District Hospital; Macmillan Cancer Unit

    Yeovil, BA21 4AT

  • Airedale General Hospital; Oncology

    York, BD20 6TD

Other trials in United Kingdom

Belgium16 sites

  • ZNA Middelheim

    Antwerp, 2020

  • CH EpiCURA Site Louis Caty

    Baudour, 7331

  • AZ KLINA

    Brasschaat, 2930

  • AZ Sint Jan

    Bruges, 8000

  • HIS (Etterbeek Ixelles)

    Brussels, 1050

  • Hospital Erasme; Neurologie

    Brussels, 1070

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • AZ Groeninge (Kennedylaan)

    Kortrijk, 8500

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • Clinique St Pierre asbl

    Ottignies, 1340

  • AZ Delta (Campus Wilgenstraat)

    Roeselare, 8800

  • AZ Nikolaas (Sint Niklaas)

    Sint-Niklaas, 9100

  • AZ Turnhout Sint Elisabeth

    Turnhout, 2300

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Austria15 sites

  • Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

    Graz, 8036

  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

    Graz, 8036

  • Lhk Klagenfurt; Abt. Für Gynäkologie

    Klagenfurt, 9026

  • LKH Hochsteiermark; Abt. für Innere Medizin

    Leoben, 8700

  • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

    Linz, 4010

  • Lhk Feldkirch; Interne Medizin Abt.

    Rankweil, 6830

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • A. Ö. Krankenhaus Der Barmherzigen Brüder; Abt. Für Chirurgie

    Sankt Veit an der Glan, 9300

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

    Steyr, 4400

  • Krankenanstalt Rudolfstiftung; I. Med. Abt.

    Vienna, 1030

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

    Vienna, 1090

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

    Vienna, 1090

  • Wilhelminenspital; I. Medizinische Abt.

    Vienna, 1160

  • Lhk Vöcklabruck; Ii. Interne Abt.

    Vöcklabruck, 4840

  • Klinikum Kreuzschwestern Wels; Iv. Interne Abt.

    Wels, 4600

Other trials in Austria

Spain9 sites

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

    Jaén, 23007

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital General de Mataro; Servicio de Oncologia

    Mataró, Barcelona, 08304

  • Hospital de Navarra; Servicio de Oncologia

    Navarra, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

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

    Toledo, 45004

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Sweden9 sites

  • Gävle sjukhus onkologkliniken

    Gävle, 80187

  • Lanssjukhuset Ryhov; Onkologkliniken

    Jönköping, 55185

  • Länssjukhuset Kalmar; Oncology

    Kalmar, 39185

  • Centralsjukhuset Karlstad, Onkologkliniken

    Karlstad, 65185

  • Uni Hospital Linkoeping; Dept. of Oncology

    Linköping, 58185

  • Skånes University Hospital, Skånes Department of Onclology

    Lund, 22185

  • Karolinska Hospital; Oncology - Radiumhemmet

    Stockholm, 17176

  • Länssjukhuset Sundsvall, Onkologkliniken

    Sundsvall, 85186

  • Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology

    Umeå, 90185

Other trials in Sweden

Hungary4 sites

  • Semmelweis Egyetem Onkologiai Központ

    Budapest, 1083

  • Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

    Budapest, 1145

  • Josa Andras Korhaz; Dept of Oncoradiology

    Nyíregyháza, 4400

  • Vas Megyei Markusovszky Korhaz ; Pulmonology

    Szombathely, 9700

Other trials in Hungary

Poland2 sites

  • Regionalne Centrum Onkologi; Oddzial Chorob Wewnetrznych I Onkologii

    Bydgoszcz, 85-796

  • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

    Poznan, 60-569

Other trials in Poland

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
trastuzumab [Herceptin]
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trastuzumab [Herceptin]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.

Study groups in NCT01152606
Study groupRoleWhat they receive
CohortNot described
Receives: Drug: trastuzumab [Herceptin]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death

    Measured: On treatment and up to 5 years follow-up

Secondary outcomes (2)

  1. Time to onset and the time to recovery of symptomatic congestive heart failure

    Measured: On treatment and up to 5 years follow-up

  2. Incidence of asymptomatic cardiac failure and other significant cardiac conditions

    Measured: On treatment and up to 5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2010 (estimated)
  2. Study start30 Aug 2007
  3. Primary completion31 May 2016
  4. Study completion31 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,942 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01152606
Sponsor's protocol ID
BO20652
Status last verified
Jan 2018
First submitted
28 Jun 2010
Last updated
25 Jan 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hoffmann-La Roche at 205 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in Germany, Italy, United Kingdom, Belgium, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.

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Clinical Trial NCT01152606 | AzTrials