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)

July 2, 2025 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1486

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.
      • Salzburg, Austria, 5020
        • Lkh Salzburg - Univ. Klinikum Salzburg
      • Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Gent, Belgium, 9000
        • AZ Sint Lucas (Sint Lucas)
      • Liège, Belgium, 4000
        • CHU de Liège (Sart Tilman)
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Brazil
      • Rio De Janeiro, Brazil, 22290-160
        • Clinicas Oncologicas Integradas - COI
      • Rio de Janeiro, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa
    • Paraná
      • Curitiba, Paraná, Brazil, 80530-010
        • Iop Instituto de Oncologia Do Parana
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96015-280
        • UPCO - Unidade de Pesquisas Clínicas em Oncologia
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
        • Hospital Moinhos de Vento
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • Sao Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, São Paulo, Brazil, 01317-000
        • Hospital Perola Byington
      • Sao Paulo, São Paulo, Brazil, 01236-030
        • Instituto de Ensino e Pesquisa Sao Lucas - IEP
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Arthur J.E. Child Comprehensive Cancer Center
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • 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
      • 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 3E4
        • Centre Hospitalier de l?Université de Montréal (CHUM)
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Hopital du Saint Sacrement
  • China
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Guangzhou, China, 510060
        • Sun Yet-sen University Cancer Center
      • Guangzhou, China, 510080
        • Guangdong General Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200025
        • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  • Colombia
      • Bogota, Colombia, 11001
        • Clinica del Country
      • Medellin-Antioquia, Colombia
        • Hospital Pablo Tobon Uribe
      • Monteria, Colombia
        • Oncomedica S.A.
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 779 00
        • Fakultni Nemocnice Olomouc
      • Praha, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice V Praze
  • France
      • Avignon, France, 84918
        • Institut Sainte Catherine
      • Besancon, France, 25030
        • Hôpital Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Le Mans, France, 72000
        • Centre de Cancerologie de la Sarthe, Clinique Victor HugoSoReCOH
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Montpellier, France, 34298
        • Centre Val Aurelle Paul Lamarque
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75475
        • Hopital Saint Louis
      • Paris, France, 75231
        • Institut Curie
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • St Cloud, France, 92210
        • Centre Rene Huguenin
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Augsburg, Germany, 86150
        • Hämatologie Onkologie im Zentrum MVZ GmbH
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Berlin, Germany, 14169
        • Studienzentrum Berlin City
      • Berlin-Lichtenberg, Germany, 10367
        • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
      • Bielefeld, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld
      • Böblingen, Germany, 71032
        • Klinikum Sindelfingen-Böblingen
      • Dortmund, Germany, 44137
        • St. Johannes-Hospital
      • Düsseldorf, Germany, 40235
        • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
      • Esslingen, Germany, 73730
        • Klinikum Esslingen
      • Frankfurt, Germany, 60596
        • Klinik Johann Wolfgang von Goethe Uni
      • Frankfurt am Main, Germany, 60389
        • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Gelsenkirchen, Germany, 45879
        • Evangelische Kliniken Gelsenkirchen GmbH
      • Greifswald, Germany, 17475
        • Universitätsklinikum Greifswald
      • Halle, Germany, 06110
        • Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
      • Halle, Germany, 06097
        • Universitätsklinikum Halle (Saale)
      • Hamburg, Germany, 20357
        • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
      • Hamm, Germany, 59073
        • St. Barbara-Klinik Hamm-Heessen GmbH
      • 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)
      • Kassel, Germany, 34125
        • Klinikum Kassel Gmbh
      • Kassel, Germany, 34117
        • Elisabeth-Krankenhaus Brustzentrum
      • Kiel, Germany, 24105
        • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
      • Koeln, Germany, 50935
        • St. Elisabeth Krankenhaus Köln GmbH
      • Köln, Germany, 51067
        • Kliniken der Stadt Köln gGmbH Krankenhaus Holweide
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
      • München, Germany, 80337
        • Klinikum der Universität München
      • München, Germany, 80639
        • Medizinisches Zentrum für Hämatologie und Onkologie
      • Nordhausen, Germany, 99734
        • MVZ Nordhausen gGmbH, Praxis Dr. Grafe
      • Offenbach, Germany, 63069
        • Sana Klinikum Offenbach GmbH
      • Paderborn, Germany, 33098
        • St. Vincenz-Krankenhaus Paderborn
      • 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
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus
      • Traunstein, Germany, 83278
        • Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm Am Michelsberg
      • Wiesbaden, Germany, 65199
        • Helios Dr. Horst Schmidt Kliniken Wiesbaden
      • Witten, Germany, 58452
        • Marien-Hospital Witten
      • Würzburg, Germany, 97080
        • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
  • Greece
      • Heraklion, Greece, 71110
        • Univ General Hosp Heraklion
      • Thessaloniki, Greece, 54645
        • Euromedical General Clinic of Thessaloniki
  • Guatemala
      • Guatemala, Guatemala, 01009
        • Centro Oncológico Sixtino / Centro Oncológico SA
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong, 852
        • Tuen Mun Hospital
  • Ireland
      • Cork, Ireland
        • Cork Uni Hospital
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, 4
        • St Vincent'S Uni Hospital
      • Dublin, Ireland, 7
        • Mater Misericordiae Uni Hospital
      • Galway, Ireland
        • Galway Uni Hospital
      • Limerick, Ireland
        • University Hospital Limerick - Oncology
  • Israel
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Petach Tikva, Israel, 4941492
        • Rabin MC
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Napoli, Campania, Italy, 80131
        • Università degli Studi Federico II
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Policlinico S.Orsola-Malpighi
      • Bologna, Emilia-Romagna, Italy, 40139
        • Ausl Di Bologna-Ospedale Bellaria
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico
      • Roma, Lazio, Italy, 00189
        • Az. Osp. Sant'Andrea
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Asst Papa Giovanni XXIII
      • Cremona, Lombardia, Italy, 26100
        • ASST di Cremona
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milano, Lombardia, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, Lombardia, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Monza, Lombardia, Italy, 20052
        • Asst Di Monza
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
        • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino
    • Toscana
      • Pisa, Toscana, Italy, 56100
        • Azlenda Ospendaliero-Universitaria Pisana
      • Pontedera, Toscana, Italy, 56025
        • Azienda usl 5 Di Pisa-Ospedale Di Pontedera
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS
      • Verona, Veneto, Italy, 37126
        • A.O.U.I. Verona-Ospedale Borgo Trento
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Médicos Especialistas en Cáncer SC
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional De Cancerologia
      • Mexico City, Mexico, 14080
        • Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 06760
        • Hospital Angeles Metropolitano
  • Panama
      • Panama, Panama, 0834-02723
        • Centro Oncologico America
      • Panama City, Panama, 0832
        • The Panama Clinic
  • Peru
      • Arequipa, Peru
        • Centro Medico Monte Carmelo
      • Arequipa, Peru, 04001
        • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud
      • Bellavista, Peru, Callao 2
        • Hospital IV Alberto Sabogal Sologuren
      • Lima, Peru, Lima 41
        • Clinica San Borja
      • Lima, Peru, 13
        • Hospital Nacional Guillermo Almenara Irigoyen
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • South Africa
      • Cape Town, South Africa, 7570
        • Cape Town Oncology Trials
      • Johannesburg, South Africa, 2196
        • Medical Oncology Centre of Rosebank
      • Parktown, South Africa
        • Wits Donald Gordon Clinical Trial Centre
      • Pietermaritzburg, South Africa, 3201
        • Hopelands Cancer Centre
      • Port Elizabeth, South Africa, 6045
        • Cancercare
      • Pretoria, South Africa, 0081
        • Private Oncology Centre
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
      • Malaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Navarra, Spain, 31008
        • Hospital de Navarra
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
      • Valencia, Spain, 46009
        • Instituto Valenciano Oncologia
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
        • Hospital de Donostia
    • Madrid
      • Leganes, Madrid, Spain, 28911
        • Hospital Severo Ochoa
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus
  • Sweden
      • Gävle, Sweden, 801 87
        • Gävle sjukhus
      • Lund, Sweden, 22185
        • Skånes University Hospital, Skånes Department of Onclology
      • Stockholm, Sweden, 17176
        • Karolinska hospital
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau AG Medizin Onkologie
      • Zürich, Switzerland, 8008
        • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital
      • Taipei, Taiwan, 00112
        • Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou
  • Turkey
      • Bursa, Turkey, 16059
        • Uludag Uni Hospital
      • Edirne, Turkey, 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Istanbul, Turkey, 34000
        • Kartal Dr Lutfi Kirdar Sehir Hastanesi
      • Izmir, Turkey, 35100
        • Ege Uni Medical Faculty Hospital
      • 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
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cottingham, United Kingdom, HU16 5JG
        • Castle Hill Hospital
      • Devon, United Kingdom, EX31 4JB
        • North Devon District Hospital
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hosp NHS Trust
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall 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
      • 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
    • Connecticut
      • New Haven, Connecticut, United States, 06510-3221
        • Yale Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32806
        • UF Health Orlando
      • Tampa, Florida, United States, 33612-9497
        • 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
      • Iowa City, Iowa, United States, 52242
        • 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
      • 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 Louis Park, Minnesota, United States, 55426
        • US oncology research at Minnesota Oncology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • 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
    • North Dakota
      • Fargo, North Dakota, United States, 58122-9988
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University, Arthur James Cancer Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • 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
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • 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
      • 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
        • Centra Alan B. Pearson Regional Cancer Center
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University - Massey Cancer Center
    • Washington
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute - Issaquah
      • 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) Rate at 3 Years
Time Frame: At Year 3
IDFS event was defined as the first occurrence of any 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 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 3-year IDFS rate in ITT population was estimated using Kaplan Meier (KM) method and the percentage of participants who were event-free 3 years after randomization was estimated.
At Year 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years
Time Frame: At Year 3
IDFS including SPNBC was defined the same way as IDFS 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). IDFS event was defined as outlined in the description for IDFS rate outcome measure (OM) number 1. 3-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated.
At Year 3
IDFS Including SPNBC Rate at 7 Years
Time Frame: At Year 7
IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
At Year 7
IDFS Including SPNBC Rate at 8 Years
Time Frame: At Year 8
IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
At Year 8
Disease-free Survival (DFS) Rate at 3 Years
Time Frame: At Year 3
DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral ductal carcinoma in situ (DCIS). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 3-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated.
At Year 3
DFS Rate at 7 Years
Time Frame: At Year 7
DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
At Year 7
DFS Rate at 8 Years
Time Frame: At Year 8
DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
At Year 8
Overall Survival (OS) Rate at 5 Years
Time Frame: At Year 5
OS was defined as the time from randomization to death due to any cause. 5-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 5 years after randomization was estimated.
At Year 5
OS Rate at 7 Years
Time Frame: At Year 7
OS was defined as the time from randomization to death due to any cause. 7-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
At Year 7
OS Rate at 8 Years
Time Frame: At Year 8
OS was defined as the time from randomization to death due to any cause. 8-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
At Year 8
Distant Recurrence-free Interval (DRFI) Rate at 3 Years
Time Frame: At Year 3
DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated.
At Year 3
DRFI Rate at 7 Years
Time Frame: At Year 7
DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 7-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
At Year 7
DRFI Rate at 8 Years
Time Frame: At Year 8
DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 8-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
At Year 8
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From signing of informed consent till end of follow up (up to approximately 131 months)
AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable & unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, whether or not considered related to medicinal product. SAE=any AE that met any given criteria: fatal (i.e. AE causes/leads to death); life-threatening (i.e. AE, in view of investigator, placed the participant at immediate risk of death); required/prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e. AE results in substantial disruption of participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in investigator's judgment. Percentages have been rounded off.
From signing of informed consent till end of follow up (up to approximately 131 months)
Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee
Time Frame: Up to approximately 126 months
Cardiac events were defined as death from cardiac cause or severe congestive heart failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10 percentage points or more from baseline to an LVEF of < 50%. Other cardiac-related events (e.g., any symptomatic congestive heart failure [CHF] associated with a 10% drop in LVEF to < 50%; asymptomatic declines in LVEF requiring dose delay) were summarized as adjudicated by the Cardiac Review Committee. Percentages have been rounded off.
Up to approximately 126 months
Percentage of Participants With Hepatotoxicity Events as Adjudicated by the Hepatic Review Committee
Time Frame: Up to approximately 64 months
Hepatotoxicity events were summarized by treatment arm. Hepatotoxicity events were assessed using liver function laboratory test (LFT) results which included the analysis of baseline and post-baseline levels of alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBILI), and alkaline phosphatase (ALK). Hepatic events, as adjudicated by the Hepatic Review Committee, are summarized. Percentages have been rounded off.
Up to approximately 64 months
Number of Participants Who Discontinued Treatment Due to AEs
Time Frame: Up to approximately 9.6 months
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were treated for up to 14 cycles (1 cycle = 21 days).
Up to approximately 9.6 months
Number of Participants With AEs and SAEs Leading to Death
Time Frame: From signing of informed consent till end of follow up (up to approximately 131 months)
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that met any of the following criteria: fatal (i.e., the AE actually causes or leads to death); life-threatening (i.e., the AE, in the view of the investigator, placed the participant at immediate risk of death); required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e., the AE results in substantial disruption of the participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in the investigator's judgment.
From signing of informed consent till end of follow up (up to approximately 131 months)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Time Frame: Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)
The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), a global health status/quality of life (GHS/QoL) scale, three symptom scales (fatigue, pain, nausea, and vomiting), five single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and a perceived financial impact of the disease item. Most questions used a 4-point scale (1= Not at all to 4 = Very much; 2 questions used a 7-point scale [1 = very poor to 7 = Excellent]). Obtained scores are linearly transformed to a score range of 0-100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms. A positive change from baseline indicates improvement.
Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)
Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
Time Frame: Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)
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). Obtained scores are linearly transformed to a score range of 0-100. 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 QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL.
Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)
Serum Concentrations of Trastuzumab Emtansine
Time Frame: Pre-infusion on Cycles 1, 2, 4 and 5; 15-30 minutes and 2 hours post-infusion on Cycles 1 and 4; treatment discontinuation/completion visit (up to approximately 64 months) (1 cycle = 21 days)
Pre-infusion on Cycles 1, 2, 4 and 5; 15-30 minutes and 2 hours post-infusion on Cycles 1 and 4; treatment discontinuation/completion visit (up to approximately 64 months) (1 cycle = 21 days)
Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)
Time Frame: Pre-infusion, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days)
Concentration of DM1 in plasma was measured through the samples obtained from participants randomized to the trastuzumab emtansine arm. DM1 is an ant-microtubule agent derived from maytansine. In transtuzumab entansine, DM1 is linked to the antibody transtuzumab thus helping the drug to specifically target the HER 2- positive cancer cells.
Pre-infusion, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days)
Serum Concentrations of Trastuzumab
Time Frame: Pre-infusion and 15-30 minutes post-infusion on Cycles 1 and 4; Treatment completion/discontinuation visit (up to approximately 64 months) (1 cycle = 21 days)
Pre-infusion and 15-30 minutes post-infusion on Cycles 1 and 4; Treatment completion/discontinuation visit (up to approximately 64 months) (1 cycle = 21 days)
Serum Concentrations of Total Trastuzumab
Time Frame: Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days)
Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm.
Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days)
Median Duration of Trastuzumab Emtansine Exposure
Time Frame: Up to 12 months
Treatment duration was defined as the time between the first and the last infusion of trastuzumab emtansine.
Up to 12 months
Number of Participants With Positive Anti-drug Antibodies (ADAs) to Trastuzumab Emtansine
Time Frame: Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months])
ADA-positive participants after drug administration were determined for participants exposed to trastuzumab emtansine. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab emtansine was determined by summing the ADA-positive participants across all timepoints.
Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months])
Number of Participants With Positive ADAs to Trastuzumab
Time Frame: Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months])
ADA-positive participants after drug administration were determined for participants exposed to trastuzumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab was determined by summing the ADA-positive participants across all timepoints.
Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months])

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IDFS Rate at 7 Years
Time Frame: At Year 7
IDFS event was defined as the first occurrence of any 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 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 7-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 7 years after randomization was estimated.
At Year 7
IDFS Rate at 8 Years
Time Frame: At Year 8
IDFS event was defined as the first occurrence of any 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 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 8-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 8 years after randomization was estimated.
At Year 8

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Collaborators

NSABP Foundation Inc
GBG Forschungs GmbH

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 (Actual)

May 23, 2024

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 (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

June 1, 2025

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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