A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

February 5, 2024 updated by: Hoffmann-La Roche

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1487

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

  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Fundación CENIT para la Investigación en Neurociencias
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (CORI)
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario
  • Austria
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
      • Salzburg, Austria, 5020
        • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische 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 - Abt. für Onkologie
  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Gent, Belgium, 9000
        • AZ Sint Lucas (Sint Lucas)
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80530-010
        • Iop Instituto de Oncologia Do Parana
    • RJ
      • Rio De Janeiro, RJ, Brazil, 22290-160
        • Clinicas Oncologicas Integradas - COI
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Oncologia
    • RS
      • Pelotas, RS, Brazil, 96020-080
        • UPCO - Unidade de Pesquisas Clínicas em Oncologia
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Porto Alegre, RS, Brazil, 90035-000
        • Hospital Moinhos de Vento
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • Sao Paulo, SP, Brazil, 01321-001
        • Hospital Sao Jose
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
      • Sao Paulo, SP, Brazil, 01236-030
        • Instituto de Ensino e Pesquisa Sao Lucas - IEP
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre; Dept of Medicine
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ; Dept of Medical Oncology
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BC Cancer ? Surrey
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital; Division of Infectious Diseases
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CSSS champlain - Charles-Le Moyne
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre - Glen Site
      • Montreal, Quebec, Canada, H2X 0C2
        • Centre Hospitalier de l?Université de Montréal (CHUM)
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint Sacrement
  • China
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Guangzhou, China, 510080
        • Guangdong General Hospital
      • Guangzhou City, China, 510663
        • Sun Yet-sen University Cancer Center
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Shanghai, China, 200025
        • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
  • Colombia
      • Bogota, Colombia, 11001
        • Clinica del Country
      • Medellin, Colombia, 050034
        • Hospital Pablo Tobón Uribe
      • Monteria, Colombia, 230002
        • Oncomedica S.A.
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Praha 2, Czechia, 128 08
        • Všeobecná fakultní nemocnice v Praze
  • France
      • Avignon, France, 84918
        • Institut Sainte Catherine;Recherche Clinique
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, France, 33076
        • Institut Bergonie; Oncologie
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat; Oncologie/Hematologie
      • Caen, France, 14076
        • Centre Francois Baclesse; Comite Sein
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin; Oncologie
      • Le Mans, France, 72000
        • Centre de Cancerologie de la Sarthe, Clinique Victor Hugo SoReCOH
      • Marseille, France, 13273
        • Institut Paoli Calmettes; Oncologie Medicale
      • Montpellier, France, 34298
        • Centre Val Aurelle Paul Lamarque; Recherche Clinique
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, France, 75475
        • Hopital Saint Louis; Oncologie Medicale
      • Rouen, France, 76038
        • Centre Henri Becquerel; Oncologie Medicale
      • St Cloud, France, 92210
        • Centre Rene Huguenin; CONSULT SPECIALISEES
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Villejuif, France, 94805
        • Institut Gustave Roussy; Departement Oncologie Medicale
  • Germany
      • Augsburg, Germany, 86150
        • Hämatologie Onkologie im Zentrum MVZ GmbH
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Berlin, Germany, 14169
        • Studienzentrum Berlin City
      • Berlin, Germany, 10367
        • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
      • Bielefeld, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld
      • Böblingen, Germany, 71032
        • Klinikum Sindelfingen-Böblingen; Frauenklinik
      • Dortmund, Germany, 44137
        • St. Johannes-Hospital
      • Düsseldorf, Germany, 40235
        • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen; Frauenklinik
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
      • Esslingen, Germany, 73730
        • Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
      • Frankfurt, Germany, 60596
        • Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
      • Frankfurt am Main, Germany, 60389
        • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg; Frauenklinik
      • Gelsenkirchen, Germany, 45879
        • Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
      • Greifswald, Germany, 17475
        • Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
      • Halle, Germany, 06120
        • Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
      • Halle, Germany, 06110
        • Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
      • Hamburg, Germany, 20357
        • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
      • Hamm, Germany, 59073
        • St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik
      • 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
      • Hannover, Germany, 30559
        • Diakovere Henriettenstift, Frauenklinik
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
      • Kassel, Germany, 34117
        • Elisabeth-Krankenhaus Brustzentrum
      • Kassel, Germany, 34125
        • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
      • Kiel, Germany, 24105
        • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
      • Koeln, Germany, 50935
        • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
      • Köln, Germany, 51067
        • Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
      • München, Germany, 80336
        • Klinikum der Universität München; Frauenklinik - Onkologie II
      • München, Germany, 80638
        • Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
      • Nordhausen, Germany, 99734
        • MVZ Nordhausen gGmbH, Praxis Dr. Grafe
      • Offenbach, Germany, 63069
        • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
      • Paderborn, Germany, 33098
        • St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
      • Recklinghausen, Germany, 45659
        • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
      • Reutlingen, Germany, 72764
        • Klinikum am Steinenberg Frauenklinik
      • Rostock, Germany, 18059
        • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
      • Stralsund, Germany, 18439
        • Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus; Brustzentrum
      • Traunstein, Germany, 83278
        • Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen; Frauenklinik
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
      • Wiesbaden, Germany, 65199
        • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
      • Witten, Germany, 58452
        • Marien-Hospital Witten; Frauenklinik Brustzentrum
      • Würzburg, Germany, 97080
        • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
  • Greece
      • Heraklion, Greece, 711 10
        • Univ General Hosp Heraklion; Medical Oncology
      • Thessaloniki, Greece, 546 45
        • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Centro Oncológico Sixtino / Centro Oncológico SA
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital; Clinical Oncology
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital; Surgery
  • Ireland
      • Cork, Ireland
        • Cork Uni Hospital; Oncology Dept
      • Dublin, Ireland, 7
        • Mater Misericordiae Uni Hospital; Oncology
      • Dublin, Ireland, 9
        • Beaumont Hospital; Cancer Clinical Trials Unit
      • Dublin, Ireland, D04 T6F4
        • St Vincent'S Uni Hospital; Medical Oncology
      • Galway, Ireland
        • Galway Uni Hospital; Oncology Dept
      • Limerick, Ireland
        • University Hospital Limerick - Oncology
  • Israel
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center; Oncology Dept
      • Petach Tikva, Israel, 4941492
        • Rabin MC; Davidof Center - Oncology Institute
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center; Tel Hashomer
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center; Oncology Inst.
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Napoli, Campania, Italy, 80131
        • Università degli Studi Federico II; Clinica di Oncologia Medica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40139
        • Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
      • Bologna, Emilia-Romagna, Italy, 40138
        • Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
      • Roma, Lazio, Italy, 00189
        • Az. Osp. Sant'Andrea; Oncologia Medica
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
    • 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, 20141
        • Istituto Europeo di Oncologia
      • Milano, Lombardia, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
      • Milano, Lombardia, Italy, 20132
        • Irccs Ospedale San Raffaele;Oncologia Medica
      • Monza, Lombardia, Italy, 20900
        • ASST DI MONZA; Oncologia Medica
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
        • Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino; Oncologia Medica
    • Toscana
      • 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
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
      • Verona, Veneto, Italy, 37126
        • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Médicos Especialistas en Cáncer SC
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Cancerologia; Oncology
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 06760
        • Hospital Angeles Metropolitano; Room 220
      • Mexico City, Mexico CITY (federal District), Mexico, 14080
        • Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
    • Oaxaca
      • Oaxaca de Juárez, Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
  • Panama
      • Panama, Panama, 0834-02723
        • Centro Oncologico America
      • Panama, Panama, 0832-02723
        • The Panama Clinic
  • Peru
      • Arequipa, Peru, 04001
        • Centro Medico Monte Carmelo
      • Arequipa, Peru, 04001
        • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
      • Bellavista, Peru, Callao 2
        • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
      • Lima, Peru, Lima 41
        • Clinica San Borja
      • Lima, Peru, 13
        • Hospital Nacional Guillermo Almenara Irigoyen; Oncology
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • South Africa
      • Cape Town, South Africa, 7570
        • Cape Town Oncology Trials
      • Hilton, South Africa, 3245
        • Hopelands Cancer Centre
      • Johannesburg, South Africa, 2196
        • Medical Oncology Centre of Rosebank; Oncology
      • Parktown, Johannesburg, South Africa, 2193
        • Wits Donald Gordon Clinical Trial Centre; Medical Oncology
      • Port Elizabeth, South Africa, 6045
        • Cancercare
      • Pretoria, South Africa, 0081
        • Private Oncology Centre
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Oncología
      • Madrid, Spain, 28050
        • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Malaga, Spain, 29011
        • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
      • Navarra, Spain, 31008
        • Hospital de Navarra; Servicio de Oncologia
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
      • Valencia, Spain, 46009
        • Instituto Valenciano Oncologia; Oncologia Medica
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset; Servicio de Oncologia
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
        • Hospital de Donostia; Servicio de Oncologia Medica
    • Madrid
      • Leganes, Madrid, Spain, 28911
        • Hospital Severo Ochoa; Servicio de Oncologia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
  • Sweden
      • Gävle, Sweden, 80187
        • Gävle Sjukhus; Onkologiska Kliniken
      • Lund, Sweden, 221 85
        • Skånes University Hospital, Skånes Department of Onclology
      • Stockholm, Sweden, 171 76
        • Karolinska Hospital; Oncology - Radiumhemmet
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN
      • Zürich, Switzerland, 8008
        • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital; Dept of Surgery
      • Taipei, Taiwan, 00112
        • VETERANS GENERAL HOSPITAL; Department of General Surgery
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; General Surgery
      • Taipei City, Taiwan, 11259
        • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou; Dept of Surgery
  • Turkey
      • Bursa, Turkey, 16059
        • Uludag Uni Hospital; Oncology
      • Edirne, Turkey, 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Istanbul, Turkey, 34865
        • Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
      • Izmir, Turkey, 35100
        • Ege Uni Medical Faculty Hospital; Oncology Dept
      • Malatya, Turkey, 44280
        • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital; Dept of Clinical Oncology
      • Cottingham, United Kingdom, HU16 5JG
        • Castle Hill Hospital; The Queens Centre for Oncology and Haematology
      • Devon, United Kingdom, EX31 4JB
        • North Devon District Hospital
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital; Cancer Medicine
      • Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital; Medicine Div.
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital; Medical Oncology.
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital; Oncology
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • California
      • Long Beach, California, United States, 90806
        • Todd Cancer Institute at Long Beach Memorial Medical Center
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • San Diego, California, United States, 92120
        • Kaiser Permanente - San Diego
      • Santa Ana, California, United States, 92705
        • Breastlink Medical Group Inc
      • Vallejo, California, United States, 94589
        • Kaiser Permanente - Vallejo
    • Colorado
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente - Franklin
      • Denver, Colorado, United States, 80222
        • Colorado Cancer Research Program/Admin
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers - Colorado Springs (Circle)
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute; Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida; Davis Cancer Pavilion and Shands Medical Plaza
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32806
        • UF Health Orlando
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Naperville, Illinois, United States, 60540
        • Edward Cancer Center Naperville
      • Plainfield, Illinois, United States, 60585
        • Edward Cancer Center Plainfield
    • Iowa
      • Lowa City, Iowa, United States, 52242-1086
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare Inc.
    • Maine
      • Brewer, Maine, United States, 04412
        • Cancer Care of Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center; Medical Oncology & Hematology
      • Baltimore, Maryland, United States, 21237
        • Med Star Franklin Square Medical Center/Weinburg Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospitals
      • Lansing, Michigan, United States, 48910
        • Breslin Cancer Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • US oncology research at Minnesota Oncology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
      • Sparta, New Jersey, United States, 07871-1791
        • Sparta Cancer Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Troy, New York, United States, 12180
        • Troy Cancer Treatment Program
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-2839
        • Carolinas Medical Center
      • Concord, North Carolina, United States, 28025
        • Batte Cancer Center - Carolinas Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital; Aultman Hospital Cancer Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital; Cleveland Clinic Cancer Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University, Arthur James Cancer Hospital
      • Mentor, Ohio, United States, 44060
        • Lake Health/University Hospitals - Mentor Campus
    • Oregon
      • Portland, Oregon, United States, 97213
        • Columbia River Oncology Program
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Kimmel Cancer Center Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Uni of Pittsburgh; Magee-Women'S Hospital
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina; Hollings Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37916-2305
        • Thompson Cancer Survival Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital Outpatient Center
      • Houston, Texas, United States, 77030
        • Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research & Treatment Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg, Inc.
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg Hem Onc Clinic Inc
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University - Massey Cancer Center
    • Washington
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute - Issaquah
      • Longview, Washington, United States, 98632
        • PeaceHealth St. John Medical Center - Lower Columbia Cancer Center
      • Spokane, Washington, United States, 99204
        • Cancer Care Northwest
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

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

Description

Inclusion Criteria:

  • Adult patient, >/= 18 years of age
  • HER2-positive breast cancer
  • Histologically confirmed invasive breast carcinoma
  • Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
  • Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
  • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
  • Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
  • An interval of no more than 12 weeks between the date of surgery and the date of randomization
  • Known hormone-receptor status
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic, renal and liver function
  • Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug
  • Documentation of hepatitis B virus and hepatitis C virus serology is required

Exclusion Criteria:

  • Stage IV (metastatic) breast cancer
  • History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
  • Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
  • Progressive disease during preoperative systemic therapy
  • Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
  • History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
  • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
  • Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
  • History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
  • Cardiopulmonary dysfunction as defined by protocol
  • Prior treatment with trastuzumab emtansine
  • Current severe, uncontrolled systemic disease
  • Pregnant or lactating women
  • Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
  • Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
  • History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trastuzumab
Drug: trastuzumab
6 mg/kg intravenously every 3 weeks, 14 cycles
Experimental: Trastuzumab emtansine
Drug: trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks, 14 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-free Survival (IDFS)
Time Frame: From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)
IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-free Survival Including Second Primary Non-breast Cancer
Time Frame: From baseline up to 12 years
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). 3-year IDFS including second primary non-breast cancer event-free rates per treatment arm in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
From baseline up to 12 years
Disease-free Survival
Time Frame: From baseline up to 12 years
Disease-free survival was defined as the time between randomization and the date of the first occurrence of an invasive disease-free survival event including second primary non-breast cancer event or contralateral or ipsilateral DCIS. 3-year DFS event-free rates per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
From baseline up to 12 years
Overall Survival (OS)
Time Frame: Baseline up to 12 years
Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 5 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 5 years after treatment.
Baseline up to 12 years
Distant Recurrence-Free Interval (DRFI)
Time Frame: Baseline up to 12 years
DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3 years DRFI event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.
Baseline up to 12 years
Percentage of Participants With Adverse Events
Time Frame: From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)
Percentage of Participants With Cardiac Dysfunction
Time Frame: From baseline up to 12 years
Cardiac events were reported based on the NCI-CTCAE, v4.0.
From baseline up to 12 years
Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Time Frame: Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12
Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
Time Frame: Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in quality of life (QOL) and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in quality of life (QOL) and negative change from baseline indicated a deterioration in QOL.
Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1)
Time Frame: Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination
Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm.
Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination
Serum Concentrations (AUC) of Trastuzumab
Time Frame: C1D1 and C4D1 of post-infusion and study treatment termination
Serum blood samples were collected for trastuzumab measurement prior to dosing and 15-30 minutes post infusion for Cycle 1 and Cycle 4. Additional serum samples were collected at study treatment termination.
C1D1 and C4D1 of post-infusion and study treatment termination
Plasma Concentrations of DM1
Time Frame: Day 1 on Cycles 1 and 4. Each cycle is 21 days.
Day 1 on Cycles 1 and 4. Each cycle is 21 days.
Trastuzumab Emtansine Exposure
Time Frame: Day 1 on Cycles 1, 2, 4 and 5, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Day 1 on Cycles 1, 2, 4 and 5, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Anti-trastuzumab Emtansine Antibody (ATA)
Time Frame: Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Anti-trastuzumab Antibody (ATA)
Time Frame: Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Collaborators

NSABP Foundation Inc
German Breast Group

Investigators

  • Study Director: Clinical Trials, 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)

April 3, 2013

Primary Completion (Actual)

July 25, 2018

Study Completion (Estimated)

April 3, 2025

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimated)

January 21, 2013

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO27938
  • 2012-002018-37 (EudraCT Number)

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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