A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)

April 26, 2021 updated by: Hoffmann-La Roche

A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2577

Phase

  • Phase 3

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

  • Albania
      • Tirana, Albania, 1000
        • University "Mother Theresa" Hospital Center; Oncology Department
  • Algeria
      • Algiers, Algeria, 16000
        • CPMC; Service d'Oncologie Médicale
  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Fundación CENIT para la Investigación en Neurociencias
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico; Oncologia
      • Zarate, Argentina, 2800
        • Instituto de Investigaciones Clínicas Zárate
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital; Cancer Care Centre
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital; Oncology
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital; Division of Cancer Services
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Queen Elizabeth Hospital; Medical Oncology
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Western Hospital
      • Frankston, Victoria, Australia, 3199
        • Peninsula and South Eastern Haematology and Oncology Group
      • Malvern, Victoria, Australia, 3144
        • Cabrini Medical Centre; Oncology
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital; Department of Medical Oncology
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • University clinical center of the Republic of Srpska
      • Sarajevo, Bosnia and Herzegovina, 7100
        • Clinic of Oncology, University Clinical Center Sarajevo
  • Brazil
    • BA
      • Salvador, BA, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
      • Salvador, BA, Brazil, 41820-021
        • Centro de Oncologia da Bahia - CENOB
    • RS
      • Porto Alegre, RS, Brazil, 90035-001
        • Hospital Moinhos de Vento
    • SP
      • Jau, SP, Brazil, 17210-120
        • Hospital Amaral Carvalho
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
      • Sofia, Bulgaria, 1303
        • MHAT Serdika; Department of medical oncology
      • Sofia, Bulgaria, 1784
        • SHATOD - Sofia
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ; Dept of Medical Oncology
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa; Oncology
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CSSS champlain - Charles-Le Moyne
      • Montreal, Quebec, Canada, H3A 1A1
        • Mcgill University - Royal Victoria Hospital; Oncology
  • Chile
      • Antofagasta, Chile, 1240000
        • Centro Oncologico Antofagasta
      • Santiago, Chile, 8380000
        • Instituto Nacional del Cancer
      • Temuco, Chile, 4800827
        • Sociedad de Investigaciones Medicas Ltda (SIM)
      • Valparaiso, Chile, 2341391
        • Hospital Carlos Van Buren, Servicio de Oncologia
  • Colombia
      • Bogota, Colombia, 11001
        • Clinica del Country
      • Cali, Colombia
        • Clínica Imbanaco; Oncology
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centre Zagreb
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykův onkologický ústav; Klinika komplexní onkologické péče
      • Olomouc, Czechia, 775 20
        • Fakultni nemocnice Olomouc
      • Praha 5, Czechia, 150 06
        • Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
  • Dominican Republic
      • Santiago, Dominican Republic, 51000
        • Hospital Metropolitano de Santiago
  • Ecuador
      • Cuenca, Ecuador, EC010107
        • Instituto de Cáncer SOLCA Cuenca; Oncología
      • Guayaquil, Ecuador, EC090112
        • Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology
      • Quito, Ecuador, EC170124
        • Hospital Solca Quito; Oncologia
  • Egypt
      • Alexandria, Egypt, 11737
        • Alexandria Uni ; Medical Oncology
      • Cairo, Egypt, 11555
        • Manial Specialized Hospital; Oncology
      • Cairo, Egypt, 11796
        • Nci; Oncology Dept
  • El Salvador
      • Salvador, El Salvador, 01101
        • Hospital Oncologia; Oncology
  • France
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
      • Bordeaux, France, 33000
        • Clinique Tivoli; Sce Radiotherapie
      • Bourg En Bresse, France, 01012
        • Ch De Fleyriat; Pneumologie 1
      • Brest, France, 29200
        • Hopital Augustin Morvan; Federation De Cancerologie
      • Brive La Gaillarde, France, 19312
        • Ch De Brive La Gaillarde; Radiotherapie Oncologie
      • Chalon Sur Saone, France, 71100
        • Clinique Sainte Marie; Chimiotherapie
      • Dijon, France, 21034
        • Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
      • Dijon, France, 21000
        • Fondation Clement Drevon; Oncology
      • Draguignan, France, 83007
        • Ch De La Dracenie; Hopital De Jour
      • Guilherand Granges, France, 07500
        • Hopital Prive Drome Ardeche; Chir 2A 2B
      • Hyeres, France, 83400
        • Clinique Sainte Marguerite; Oncologie Medicale
      • La Roche Sur Yon, France, 85925
        • CHD Les Oudairies
      • La Tronche, France, 38700
        • Hopital Albert Michallon; Oncologie
      • Le Mans, France, 72037
        • Ch Du Mans; Medecine Hematologie Oncologie
      • LeMans, France, 72000
        • Clinique Victor Hugo
      • Levallois Perret, France, 92300
        • Centre Hartmann
      • Lille, France, 59000
        • Polyclinique Du Bois; Centre Bourgogne
      • Lille, France, 59037
        • Hopital Claude Huriez; Medecine Interne Oncologie
      • Lorient, France, 56100
        • Ch Bretagne Sud Site Scorff; Oncologie Medicale
      • Lorient, France, 56322
        • CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie
      • Lyon, France, 69338
        • Ctre Consultations La Sauvegarde
      • Marseille, France, 13285
        • Hôpital Saint Joseph; Oncologie Medicale
      • Metz, France, 57000
        • Hopital Clinique Claude Bernard; Oncologie Medicale
      • Metz Tessy, France, 74370
        • CHRA;Hematologie
      • Montpellier, France, 34070
        • Clinique Clementville; Hopital De Jour
      • Mougins, France, 06250
        • Centre Azureen De Cancerologie; Cons externes
      • Nice, France, 06189
        • Centre Antoine Lacassagne; B3 Medecine Conventionnelle
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, France, 75014
        • Hopital Cochin; Unite Fonctionnelle D Oncologie
      • Paris, France, 75181
        • Hopital Hotel Dieu; Oncologie Medicale
      • Pau, France, 64046
        • Ch Francois Mitterrand; Medecine Oncologie
      • Pierre Benite, France, 69495
        • Ch Lyon Sud; Onco Secteur Jules Courmont
      • Saint Gregoire, France, 35768
        • Chp Saint Gregoire; Cancerologie Radiotherapie
      • Saint Herblain, France, 44805
        • Ico Rene Gauducheau; Oncologie
      • Saint Jean, France, 31240
        • Clinique de L'Union; Oncologie
      • Saint Quentin, France, 02321
        • Ch De Saint Quentin; Medecine B10
      • Saint-priest-en-jarez, France, 42270
        • Institut de Cancerologie de La Loire; Pneumologie
      • St Martin Boulogne, France, 62280
        • CMCO De La Cote D Opale; Auberge De Jour
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Thonon Les Bains, France, 74203
        • Hopitaux Du Leman Site Thonon; Maternite Gynecologie
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
      • Toulouse, France, 31076
        • Clinique Pasteur; Pneumologie
      • Valenciennes, France, 59326
        • Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre-Alexis Vautrin
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg; Frauenklinik
      • Bad Soden, Germany, 65812
        • Internist; Praxis Für Haemotologie & Onkologie
      • Berlin, Germany, 10317
        • Praxis Dres. Schilling & Till
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen
      • Bielefeld, Germany, 33615
        • Katholische Hospitalvereinigung Ostwestfalen gGmbH
      • Bochum, Germany, 44787
        • Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
      • Deggendorf, Germany, 94469
        • DONAU ISAR Klinikum Deggendorf; Frauenklinik
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg; Frauenklinik
      • Georgsmarienhütte, Germany, 49124
        • Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe
      • Halle, Germany, 06110
        • Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
      • Hamburg, Germany, 20357
        • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie
      • Hannover, Germany, 30177
        • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
      • Jena, Germany, 07747
        • Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
      • Kassel, Germany, 34117
        • Elisabeth-Krankenhaus Brustzentrum
      • Koeln, Germany, 50935
        • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
      • Kulmbach, Germany, 95326
        • Klinikum Kulmbach; Frauenklinik
      • Köln, Germany, 50679
        • Praxis Dr.med. Katja Ziegler-Löhr
      • Köln, Germany, 51067
        • Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum
      • Langen, Germany, 63225
        • Dres. Andreas Köhler und Roswitha Fuchs
      • Leverkusen, Germany, 51375
        • Klinikum Leverkusen; Med. Klinik III / Onkologie
      • Ludwigsburg, Germany, 71640
        • Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
      • Lübeck, Germany, 23562
        • Onkologische Schwerpunktpraxis Lübeck
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
      • Marburg, Germany, 35037
        • Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
      • Meiningen, Germany, 98617
        • Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe
      • Memmingen, Germany, 87700
        • Klinikum Memmingen; Abt.Gynäkologie
      • Minden, Germany, 32429
        • Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
      • Mühlhausen, Germany, 99974
        • Praxis Dr.med. Steffi Busch
      • München, Germany, 80638
        • Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
      • München, Germany, 81925
        • Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik
      • Münster, Germany, 48149
        • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
      • Neuruppin, Germany, 16816
        • Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe
      • Nürnberg, Germany, 90419
        • Klinikum Nord Frauenklinik
      • Offenbach, Germany, 63069
        • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
      • Ostfildern, Germany, 73760
        • medius KLINIK OSTFILDERN-RUIT; Brustzentrum
      • Recklinghausen, Germany, 45659
        • Oncologianova GmbH
      • Rotenburg/Wümme, Germany, 27356
        • Agaplesion Diakonieklinikum Rotenburg
      • Saarbruecken, Germany, 66113
        • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
      • Schweinfurt, Germany, 97422
        • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
      • Schwerin, Germany, 19049
        • HELIOS Klinikum Schwerin; Frauenklinik
      • Stendal, Germany, 39576
        • Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe
      • Torgau, Germany, 04860
        • Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen; Frauenklinik
      • Unna, Germany, 59423
        • Katharinen-Hospital gGmbH
      • Weinheim, Germany, 69469
        • GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
      • Weißenfels, Germany, 06667
        • ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH
      • Wetzlar, Germany, 35578
        • Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe
      • Wuerselen, Germany, 52146
        • Gesellschaft für Medizinische Studien Würselen
  • Greece
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
      • Athens, Greece, 115 28
        • Alexandras General Hospital of Athens; Oncology Department
      • Athens, Greece, 115 27
        • Laiko General Hospital; 1St Pathological Clinic
      • Heraklion, Greece, 711 10
        • Periph. University General Hospital of Heraklion Crete; Oncology Department
      • Kifisia, Greece, 145 64
        • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
      • Thessaloniki, Greece, 564 29
        • Papageorgiou General Hospital; Medical Oncology
      • Thessaloniki, Greece, 546450
        • Euromedical General Clinic of Thessaloniki; Oncology Department
      • Αλεξανδρουπολη, Greece, 681 00
        • Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth
      • Λαρισα, Greece, 413 35
        • University Hospital of Larissa; Oncology
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Centro Oncológico Sixtino / Centro Oncológico SA
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital; Clinical Oncology
      • Shatin, Hong Kong
        • Prince of Wales Hosp; Dept. Of Clinical Onc
  • Hungary
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet
      • Budapest, Hungary, 1115
        • Szent Imre Hospital; Dept. of Oncology
      • Budapest, Hungary, 1032
        • Szent Margit Hospital; Dept. of Oncology
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
      • Nyíregyháza, Hungary, 4400
        • Josa Andras Korhaz; Dept of Oncoradiology
      • Pécs, Hungary, 7623
        • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
      • Szombathely, Hungary, 9700
        • Markusovszky Hospital
  • Indonesia
      • Bandung, Indonesia, 40161
        • Hasan Sadikin Hospital; Internal Medicine
      • Central Jakarta, Indonesia, 10430
        • CiptoMangunkusumo Hospital; Internal Medicine
      • East Java, Indonesia, 60286
        • Soetomo Hospital; Surgery
      • Jakarta, Indonesia, 11420
        • Dharmais National Cancer Center
      • Jogjakarta, Indonesia, 55284
        • Sardjito Hospital; Instalasi Kanker Tulip
  • Ireland
      • Dublin, Ireland, 7
        • Mater Misericordiae Uni Hospital; Oncology
      • Dublin, Ireland, 7
        • Mater Private Hospital
      • Dublin, Ireland, 9
        • Beaumont Hospital; Cancer Clinical Trials Unit
      • Limerick City, Ireland
        • University Hospital Limerick
      • Sligo, Ireland
        • Sligo General Hospital; Oncology
      • Waterford, Ireland
        • Waterford Regional Hospital; Department Of Medical Oncology
  • Italy
    • Basilicata
      • Rionero in Vulture, Basilicata, Italy, 85028
        • Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
    • Campania
      • Napoli, Campania, Italy, 80131
        • Università degli Studi Federico II; Clinica di Oncologia Medica
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera A. Cardarelli
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Parma, Emilia-Romagna, Italy, 43100
        • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
      • Piacenza, Emilia-Romagna, Italy, 29100
        • Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Azienda USL di Ravenna; Unità Operativa di Oncologia Medica
    • Lazio
      • Frosinone, Lazio, Italy, 03100
        • Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia
      • Roma, Lazio, Italy, 00161
        • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
      • Roma, Lazio, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea
      • Roma, Lazio, Italy, 00144
        • IFO - Istituto Regina Elena; Oncologia Medica
      • Viterbo, Lazio, Italy, 01100
        • Ospedale Belcolle Di Viterbo; Oncologia
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Asst Papa Giovanni XXIII; Oncologia Medica
      • Cremona, Lombardia, Italy, 26100
        • ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
      • Milano, Lombardia, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2
      • Monza, Lombardia, Italy, 20900
        • ASST DI MONZA; Oncologia Medica
      • Pavia, Lombardia, Italy, 27100
        • IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia
      • Rozzano, Lombardia, Italy, 20089
        • IRCCS Istituto Clinico Humanitas; Oncologia
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
      • 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, 09121
        • Ospedale Oncologico A.Businco; Div. Oncologia Medica II
      • Sassari, Sardegna, Italy, 07100
        • Ospedale Civile SS Annunziata; oncologia medica
    • Sicilia
      • Catania, Sicilia, Italy, 95100
        • Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
      • Pisa, Toscana, Italy, 56100
        • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
      • Pontedera, Toscana, Italy, 56025
        • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
    • Veneto
      • Camposampiero, Veneto, Italy, 35012
        • Ospedale Civile; Oncologia Medica
      • Cona (Ferrara), Veneto, Italy, 44124
        • Arcispedale S.Anna; Oncologia Medica
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Severance Hospital; Medical Oncology
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center.
      • Seoul, Korea, Republic of, (0)6351
        • Samsung Medical Center
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
      • Klaipeda, Lithuania, 92288
        • Klaipeda university hospital
  • Malaysia
      • Georgetown, Malaysia, 10990
        • Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre; Clinical Oncology Unit,
      • Sabah, Malaysia, 88996
        • Hospital Wanita Dan Kanak-kanak Sabah
      • Sarawak, Malaysia, 93586
        • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
  • Mexico
      • Campeche, Mexico, 24096
        • Centro Estatal de Oncología de Campeche
      • Chihuahua, Mexico, 31000
        • Centro Estatal de Cancerología
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cancerologia; Oncology
      • Mexico City, Mexico, 03100
        • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
      • Queretaro, Queretaro, Mexico, 76090
        • Cancerologia de Queretaro; Oncologia
      • Tepic, Mexico, 63170
        • Centro Estatal de Cancerologia de Nayarit
  • Morocco
      • Rabat, Morocco, 6213
        • Institut National D'oncologie Sidi Med Benabdellah
  • Netherlands
      • 'S Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
      • AC Amsterdam, Netherlands, 1091
        • Onze Lieve Vrouwe Gasthuis
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate Ziekenhuis; Inwendige Geneeskunde
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis - loc Dordrecht
      • EDE, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis; Dept of Internal Medicin
      • Eindhoven, Netherlands, 5631 BM
        • Maxima Medisch Centrum; Inwendige Geneeskunde
      • Groningen, Netherlands, 9728 NT
        • Martini Ziekenhuis; Dept of Internal Medicine
      • Heerlen, Netherlands, 6419 PC
        • Atrium Medisch Centrum Parkstad, Heerlen
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis; Inwendige Geneeskunde
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis Nieuwegein
      • Roosendaal, Netherlands, 4708 AE
        • Franciscus Ziekenhuis
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia Ziekenhuis
      • Rotterdam, Netherlands, 3079 DZ
        • Maasstad ziekenhuis; Afdeling oncologie hematologie
      • Schiedam, Netherlands, 3100 AE
        • Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde
      • Sittard-Geleen, Netherlands, 6162 BG
        • Zuyderland ziekenhuis locatie Geleen
      • Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis Utrecht: ziekenhuisapotheek
      • Venlo, Netherlands, 5912 BL
        • Ziekenhuis VieCurie Vitaal
      • Zaandam, Netherlands, 1502 DV
        • Zaans Medisch Centrum
  • New Zealand
      • Tauranga, New Zealand, 3112
        • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
  • Norway
      • Kristiansand, Norway, 4604
        • Sørlandet Sykehus Kristiansand
      • Oslo, Norway, 0450
        • Oslo universitetssykehus HF, Ullevål, Kreftsenteret
      • Stavanger, Norway, 4011
        • Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
  • Pakistan
      • Islamabad, Pakistan, 44000
        • Shifa International Hospital; Department of Oncology
      • Karachi, Pakistan, 74800
        • Aga Khan University; Department of Oncology
      • Lahore, Pakistan, 54000
        • Shaukat Khanum Memorial Cancer Hospital; Department of Oncology
      • Lahore, Pakistan, 54600
        • Hameed Latif Hospital; Department of Oncology
  • Panama
      • Panama, Panama, 0832
        • Centro Hemato Oncologico Panama
  • Peru
      • Arequipa, Peru, 04001
        • Centro Médico Monte Carmelo
      • LIma, Peru, Lima27
        • Instituto Oncologico de Lima
      • Lima, Peru, Lima 41
        • Clinica de Especialidades Medicas
      • Lima, Peru, Lima 41
        • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Philippines
      • Manila, Philippines, 1000
        • Philippine General Hospital; Section Of Medical Oncology
      • Quezon City, Philippines, 1100
        • East Avenue Medical Center
  • Poland
      • Kraków, Poland, 30-688
        • Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki
      • Otwock, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
      • Poznan, Poland, 60-569
        • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologi
      • Rzeszow, Poland, 35-021
        • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Zespolony
      • Zory, Poland, 44-240
        • NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna
  • Portugal
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz; Departamento de Oncologia Medica
      • Lisboa, Portugal, 1400-038
        • Centro Clinico Champalimaud; Oncologia Medica
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Oncologia Medica
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao; Servico de Oncologia
  • Romania
      • Baia Mare, Romania, 430241
        • Policlinica Sfanta Maria - Oncology; Medical Oncology
      • Bucharest, Romania, 050098
        • Emergency University Bucharest Hospital; Oncology Department
      • Bucuresti, Romania, 022328
        • Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
      • Cluj Napoca, Romania, 400015
        • Prof. Dr. I. Chiricuta Institute of Oncology
      • Cluj-Napoca, Romania, 400006
        • Cluj Clinical County Hospital; Oncology Dept
      • Craiova, Romania, 200385
        • Sc Oncolab Srl
      • Craiova, Romania, 200642
        • Clinical Hospital 1 Craiova; Medical Oncology
      • Timisoara, Romania, 300239
        • ONCOMED - Medical Centre
      • Timisoara, Romania, 300167
        • S.C. Life Search S.R.L; Medical Oncology Clinic
  • Russian Federation
      • Irkutsk, Russian Federation, 664035
        • Regional Oncology Hospital
      • Izhevsk, Russian Federation, 426009
        • City Oncological Hospital
      • Moscow, Russian Federation, 143423
        • City Clinical Oncology Hospital
      • Moscow, Russian Federation, 115478
        • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
      • Orenburg, Russian Federation, 460021
        • State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
      • Saint-Petersburg, Russian Federation, 198255
        • City Clinical Oncology Dispensary, SPb SBIH CCOD
      • UFA, Russian Federation, 450054
        • Bashkirian Republican Clinical Oncology Dispensary
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21499
        • King Faisal Specialist Hospital & Research Centre
      • Riyadh, Saudi Arabia, 22490
        • King Abdul Aziz Medical City, King Fahd National Guard; Oncology
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
      • Belgrade, Serbia, 11000
        • Institute for Onc/Rad Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Nis, Serbia, 18000
        • Clinical Centre Nis, Clinic for Oncology
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre; Medical Oncology
  • Slovakia
      • Banská Bystrica, Slovakia, 974 01
        • Mammacentrum sv. Agáty
      • Bratislava, Slovakia, 811 05
        • National Cancer Institute - Comenius University; Dept. Clinical Oncology
      • Košice, Slovakia, 040 01
        • Východoslovenský Onkologický Ústav
      • Presov, Slovakia, 081 81
        • Fakultna nemocnica s poliklinikou J.A. Reimana Presov
      • Trencin, Slovakia, 911 71
        • Fakultna nemocnica Trencín; Onkologicke odd.
  • Slovenia
      • Maribor, Slovenia, 2000
        • University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology
  • South Africa
      • Durban, South Africa, 4058
        • Westridge Medical Center
      • Johannesburg, South Africa, 2193
        • Donald Gordon Medical Centre
      • Pretoria, South Africa, 0002
        • Steve Biko Academic Hospital; Oncology
  • Spain
      • Albacete, Spain, 02006
        • Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia
      • Alicante, Spain, 3010
        • Hospital General Univ. de Alicante; Servicio de Oncologia
      • Barcelona, Spain, 08003
        • Hospital del Mar; Servicio de Oncologia
      • Barcelona, Spain, 08907
        • Hospital Duran i Reynals; Oncologia
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
      • Burgos, Spain, 09006
        • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
      • Caceres, Spain, 10003
        • Hospital San Pedro De Alcantara; Servicio de Oncologia
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
      • Leon, Spain, 24071
        • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
      • Lerida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28050
        • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
      • Navarra, Spain, 31008
        • Hospital de Navarra; Servicio de Oncologia
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
    • Alicante
      • Elda, Alicante, Spain, 03600
        • Hospital General de Elda; Servicio de Oncologia
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Hospital de Cabueñes; Servicio de Oncologia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07014
        • Hospital Universitario Son Espases
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
        • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
      • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35020
        • Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Hospital Quiron de Madrid; Servicio de Oncologia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36214
        • Hospital Do Meixoeiro; Servicio de Oncologia
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias;servicio de Oncologia
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
    • Valencia
      • Xativa, Valencia, Spain, 46800
        • Hospital Lluis Alcanys; Servicio de Oncologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto; Servicio de Oncologia
  • Sweden
      • Lund, Sweden, 221 85
        • Skånes University Hospital, Skånes Department of Onclology
      • Skoevde, Sweden, 54185
        • Skaraborgs sjukhus Skoevde, Dept of surgery
  • Switzerland
      • Aarau, Switzerland, 5000
        • Hirslanden Medical Center, Tumorzentrum
      • Baden, Switzerland, 5405
        • Kantonsspital Baden; Frauenklinik
      • Bellinzona, Switzerland, 6500
        • Ospedale San Giovanni; Oncologia
      • Bern, Switzerland, 3010
        • Inselspital Bern; Universitätsklinik für medizinische Onkologie
      • Frauenfeld, Switzerland, 8501
        • Kantonsspital Frauenfeld, Frauenklinik Thurgau
      • Lausanne, Switzerland, 1011
        • CHUV; Departement d'Oncologie
      • Thun, Switzerland, 3600
        • Spital Thun; Medizinische Klinik
      • Winterthur, Switzerland, 8401
        • Kantonsspital Winterthur; Medizinische Onkologie
      • Zürich, Switzerland, 8063
        • Stadtspital Triemli; Frauenklinik
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital; Surgery
      • Tainan, Taiwan, 704
        • National Cheng Kung Uni Hospital; Surgery
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; General Surgery
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital, Division of General Surgery
  • Thailand
      • Bangkok, Thailand, 10330
        • Department of Surgery, King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Pramongkutklao Hospital; Medicine - Medical Oncology Unit
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Medicine/Oncology
      • Bangkok, Thailand, 10400
        • Rajvithi Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
      • Dusit, Thailand, 10300
        • Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara Uni School of Medicine; Medical Oncology
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty; Medical Oncology Department
      • Diyarbakir, Turkey, 21280
        • Dicle University Faculty of Medicine
      • Gaziantep, Turkey, 27310
        • Gaziantep Univ. Med. Fac.
      • Istanbul, Turkey, 34390
        • Istanbul Uni of Medicine Faculty; Oncology Dept
      • Istanbul, Turkey, 34890
        • Marmara Uni Faculty of Medicine; Medical Oncology
      • Izmit, Turkey, 31380
        • Kocaeli University Faculty of Medicine; Medical oncology
      • Mersin, Turkey, 33169
        • Mersin University Medical Faculty
      • Samsun, Turkey, 55139
        • 19 Mayis University Medical Faculty; Medical Oncology Department
      • Sihhiye/Ankara, Turkey, 06230
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Ukraine
      • Kiev, Ukraine, 03115
        • Kyiv City Clinical Oncological Center; Chemotherapy Department
      • Lviv, Ukraine, 79031
        • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
  • United Arab Emirates
      • Al Ain, United Arab Emirates, 15258
        • Tawam Hospital
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Nevill Hall Hospital
      • Bedford, United Kingdom, MK42 9DJ
        • Bedford Hospital; Oncology
      • Berkshire, United Kingdom, SL2 4HL
        • Wexham Park Hospital; Oncology
      • Birmingham, United Kingdom, B17 0NH
        • University Hospital Birmingham Queen Elizabeth Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital; Department Of Medicine
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital; Oncology
      • Canterbury, United Kingdom, CT1 3NG
        • Kent & Canterbury Hospital
      • Chelmsford, United Kingdom, CM1 7ET
        • Broomfield Hospital; Oncology
      • Denbighshire, United Kingdom, LL18 5UJ
        • Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Devon, United Kingdom, EX31 4JB
        • North Devon District Hospital
      • Dudley, United Kingdom, DY1 2HQ
        • Russells Hall Hospital; Oncology
      • Durham, United Kingdom, DH15TW
        • University Hospital of North Durham
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Greenock, United Kingdom, PA16 0XN
        • Inverclyde Hospital
      • Grimsby, United Kingdom, DN33 2BA
        • Diana Princess of Wales Hosp.
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Harlow, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital; Oncology Department
      • Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Kilmarnock, United Kingdom, KA2 0BE
        • Crosshouse Hospital; Dept of Oncology
      • Larbert, United Kingdom, FK5 4QE
        • Forth Valley Royal Hospital ; Oncology Department
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Livingston, United Kingdom, EH54 6PP
        • St John's Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust, Guys Hospital
      • London, United Kingdom, SE18 4QH
        • Queen Elizabeth Hospital
      • Macclesfield, United Kingdom, SK10 3BL
        • Macclesfield District General Hospital
      • Manchester, United Kingdom, M20 4QL
        • Christie Hospital; Breast Cancer Research Office
      • New Castle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital; Northern Centre For Cancer Care
      • Newport, United Kingdom, NP20 2UB
        • Royal Gwent Hospital
      • North Shields, United Kingdom, NE29 8NH
        • North Tyneside General Hospital
      • Northampton, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital; Plymouth Oncology Centre
      • Poole, United Kingdom, BH15 2JB
        • Poole General Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital, Portsmouth
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Romford, United Kingdom, RM7 0AE
        • Queens Hospital; R&D
      • Scarborough, United Kingdom, YO12 6QL
        • Scarborough General Hospital
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital; Pharmacy Department
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital; Pharmacy Department
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
      • Winchester, United Kingdom, SO22 5DG
        • Royal Hampshire County Hospital; Winchester & Andover Breast Unit
      • Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Ctr For Oncolgy
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton Hospitals NHS Trust
      • York, United Kingdom, YO31 8HE
        • York District Hospital
      • York, United Kingdom, BD20 6TD
        • Airedale General Hospital; Oncology
  • Uruguay
      • Montevideo, Uruguay, 11400
        • Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología
      • Montevideo, Uruguay, 11600
        • Hospital Militar; Oncologia
      • Montevideo, Uruguay, 11600
        • Hospital Pereira Rossell; Oncology Department
  • Venezuela
      • Caracas, Venezuela, 1010
        • Instituto Oncologico Luis razetti
      • Caracas, Venezuela, 1060
        • Centro Integral de Oncología
      • Caracas, Venezuela, 1080
        • Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos
  • Vietnam
      • Hanoi, Vietnam, 100000
        • K hospital

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

Description

Inclusion Criteria:

  • Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%

Exclusion Criteria:

  • Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
  • History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
  • Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
  • Metastatic disease
  • Inadequate bone marrow, hepatic, or renal function
  • Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
  • History of severe allergic or immunological reactions, such as difficult-to-control asthma
  • Pregnant or lactating women

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: SC Herceptin by Needle/Syringe
Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.
Drug: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Other Names:
  • Trastuzumab
Experimental: Cohort B: SC Herceptin by SID
Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.
Drug: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Other Names:
  • Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With Treatment Interruption Due to an AE
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Number of Herceptin Cycles Received
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants by Total Number of Herceptin Cycles Received
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants Who Received Concomitant Cancer Therapy
Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
Time Frame: From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
The percentage of participants who died from any cause was reported.
From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Percentage of Participants Who Died During the Safety Follow-up Period
Time Frame: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
The percentage of participants who died from any cause was reported during the safety follow-up period.
From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
Disease-Free Survival Rate
Time Frame: From Baseline to time of event (up to approximately 8 years)

DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.

Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
From Baseline to time of event (up to approximately 8 years)
Overall Survival Rate
Time Frame: From Baseline to Time of Event (Up to Approximately 6 Years)

Overall survival was defined as the time from randomization to death from any cause.

Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
From Baseline to Time of Event (Up to Approximately 6 Years)
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Time Frame: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.
Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 17, 2012

Primary Completion (Actual)

March 10, 2015

Study Completion (Actual)

February 19, 2020

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO28048
  • 2011-005328-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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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