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)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,486

Participants

Timeline

Start Date

April 3, 2013

Primary Completion Date

July 25, 2018

Study Completion Date

May 23, 2024

Conditions
Breast Cancer
Interventions
DRUG

trastuzumab

6 mg/kg intravenously every 3 weeks, 14 cycles

DRUG

trastuzumab emtansine

3.6 mg/kg intravenously every 3 weeks, 14 cycles

Trial Locations (268)

4

St Vincent'S Uni Hospital, Dublin

7

Mater Misericordiae Uni Hospital, Dublin

9

Beaumont Hospital, Dublin

13

Hospital Nacional Guillermo Almenara Irigoyen, Lima

100

National Taiwan Uni Hospital, Taipei

112

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

407

Taichung Veterans General Hospital, Taichung

852

Queen Mary Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

1090

Medizinische Universität Wien, Vienna

1200

Cliniques Universitaires St-Luc, Brussels

2196

Medical Oncology Centre of Rosebank, Johannesburg

2610

Sint Augustinus Wilrijk, Wilrijk

3201

Hopelands Cancer Centre, Pietermaritzburg

4000

CHU de Liège (Sart Tilman), Liège

5001

Kantonsspital Aarau AG Medizin Onkologie, Aarau

5020

Lkh Salzburg - Univ. Klinikum Salzburg, Salzburg

6020

Tiroler Landeskrankenanstalten Ges.M.B.H., Innsbruck

6045

Cancercare, Port Elizabeth

7570

Cape Town Oncology Trials, Cape Town

8008

Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich, Zurich

9000

AZ Sint Lucas (Sint Lucas), Ghent

10032

Columbia University Medical Center, New York

10060

Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo, Candiolo

10367

Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare), Lichtenberg

10707

Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin

11000

Institute for Oncology and Radiology of Serbia, Belgrade

11001

Clinica del Country, Bogotá

12180

Troy Cancer Treatment Program, Troy

13125

HELIOS Klinikum Berlin-Buch, Berlin

13273

Institut Paoli Calmettes, Marseille

14076

Centre Francois Baclesse, Caen

14080

Instituto Nacional de Cancerologia, Distrito Federal

Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir, Mexico City

14169

Studienzentrum Berlin City, Berlin

15212

Allegheny Cancer Center, Pittsburgh

15213

Uni of Pittsburgh, Pittsburgh

16059

Uludag Uni Hospital, Bursa

16132

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST), Genoa

17176

Karolinska Hospital, Stockholm

17403

York Hospital, York

17475

Universitätsklinikum Greifswald, Greifswald

18059

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt, Rostock

18439

Gynäkologie Kompetenzzentrum, Stralsund

19107

Kimmel Cancer Center Thomas Jefferson University, Philadelphia

20010

Washington Cancer Institute, Washington D.C.

20052

Asst Di Monza, Monza

20080

Hospital de Donostia, Donostia / San Sebastian

20132

Irccs Ospedale San Raffaele, Milan

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20141

Istituto Europeo Di Oncologia, Milan

20230

Médicos Especialistas en Cáncer SC, Aguascalientes

20357

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg

21202

Mercy Medical Center, Baltimore

21204

Greater Baltimore Medical Center, Baltimore

Oncology Institute of Vojvodina, Kamenitz

21237

Med Star Franklin Square Medical Center/Weinburg Cancer Institute, Baltimore

22185

Skånes University Hospital, Skånes Department of Onclology, Lund

22408

Hematology Oncology Associates of Fredericksburg, Inc., Fredericksburg

22770

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne

23298

Virginia Commonwealth University - Massey Cancer Center, Richmond

24105

UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe, Kiel

24127

Asst Papa Giovanni XXIII, Bergamo

24501

Centra Alan B. Pearson Regional Cancer Center, Lynchburg

25030

Hopital Jean Minjoz, Besançon

26100

Asst Di Cremona, Cremona

28046

Hospital Universitario La Paz, Madrid

28050

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal, Madrid

28911

Hospital Severo Ochoa, Leganés

29010

Hospital Regional Universitario Carlos Haya, Málaga

29425

Medical University of South Carolina, Charleston

30559

Diakovere Henriettenstift, Frauenklinik, Hanover

30625

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hanover

31008

Hospital de Navarra, Navarra

32610

University of Florida, Gainesville

32806

UF Health Orlando, Orlando

33076

Institut Bergonie, Bordeaux

33098

St. Vincenz-Krankenhaus Paderborn, Paderborn

33140

Mount Sinai Medical Center, Miami Beach

33604

Onkologische Schwerpunktpraxis Bielefeld, Bielefeld

34000

Kartal Dr Lutfi Kirdar Sehir Hastanesi, Istanbul

34117

Elisabeth-Krankenhaus Brustzentrum, Kassel

34125

Klinikum Kassel GmbH, Kassel

34298

Centre Val Aurelle Paul Lamarque, Montpellier

35100

Ege Uni Medical Faculty Hospital, Izmir

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

36312

Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro, Vigo

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37126

A.O.U.I. Verona-Ospedale Borgo Trento, Verona

40138

Policlinico S.Orsola-Malpighi, Bologna

40139

Ausl Di Bologna-Ospedale Bellaria, Bologna

40202

Norton Healthcare Inc., Louisville

40235

Luisenkrankenhaus GmbH & Co. KG., Brustzentrum, Düsseldorf

40536

University of Kentucky Medical Center, Lexington

41013

Hospital Universitario Virgen del Rocio, Seville

43204

Hospital Universitari Sant Joan de Reus, Reus

43210

Ohio State University, Arthur James Cancer Hospital, Columbus

44111

Fairview Hospital, Cleveland

44137

St. Johannes-Hospital, Dortmund

44195

The Cleveland Clinic Foundation, Cleveland

44280

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya

44710

Aultman Hospital, Canton

45122

Universitätsklinikum Essen, Essen

45136

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH, Essen

45659

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie, Recklinghausen

45879

Evangelische Kliniken Gelsenkirchen GmbH, Gelsenkirchen

46009

Instituto Valenciano Oncologia, Valencia

46017

Hospital Universitario Dr. Peset, Valencia

48073

William Beaumont Hospital, Royal Oak

48201

Karmanos Cancer Institute, Detroit

48202

Henry Ford Health System, Detroit

48910

Breslin Cancer Center, Lansing

49503

Spectrum Health Hospitals, Grand Rapids

50935

St. Elisabeth Krankenhaus Köln GmbH, Cologne

51067

Kliniken der Stadt Köln gGmbH Krankenhaus Holweide, Cologne

52242

University of Iowa, Iowa City

52621

Sheba Medical Center, Ramat Gan

54449

Marshfield Clinic, Marshfield

54645

Euromedical General Clinic of Thessaloniki, Thessaloniki

55426

US oncology research at Minnesota Oncology, Saint Louis Park

56025

Azienda usl 5 Di Pisa-Ospedale Di Pontedera, Pontedera

56100

Azlenda Ospendaliero-Universitaria Pisana, Pisa

57105

Avera Cancer Institute, Sioux Falls

58452

Marien-Hospital Witten, Witten

59073

St. Barbara-Klinik Hamm-Heessen GmbH, Hamm

60389

Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Frankfurt am Main

60540

Edward Cancer Center Naperville, Naperville

60585

Edward Cancer Center Plainfield, Plainfield

60596

Klinik Johann Wolfgang von Goethe Uni, Frankfurt

60612

Rush University Medical Center, Chicago

63011

Centre Jean Perrin, Clermont-Ferrand

63069

Sana Klinikum Offenbach GmbH, Offenbach

65199

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden

66822

Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel, Lebach

67065

Centre Paul Strauss, Strasbourg

68000

Oaxaca Site Management Organization, Oaxaca City

69120

Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg

70376

Robert-Bosch-Krankenhaus, Stuttgart

71032

Klinikum Sindelfingen-Böblingen, Böblingen

71110

Univ General Hosp Heraklion, Heraklion

72000

Centre de Cancerologie de la Sarthe, Clinique Victor HugoSoReCOH, Le Mans

72076

Universitätsklinik Tübingen, Tübingen

72100

Ospedale Antonio Perrino, Brindisi

72764

Klinikum am Steinenberg Frauenklinik, Reutlingen

73730

Klinikum Esslingen, Esslingen am Neckar

75231

Institut Curie, Paris

75475

Hopital Saint Louis, Paris

75970

Hopital Tenon, Paris

76038

Centre Henri Becquerel, Rouen

77030

Baylor College of Medicine, Houston

Houston Methodist Hospital Outpatient Center, Houston

Uni of Texas - Md Anderson Cancer Center, Houston

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

79410

Joe Arrington Cancer Research & Treatment Center, Lubbock

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

Università degli Studi Federico II, Napoli

80205

Kaiser Permanente - Franklin, Denver

80222

Colorado Cancer Research Program/Admin, Denver

80337

Klinikum der Universität München, München

80639

Medizinisches Zentrum für Hämatologie und Onkologie, München

83278

Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung, Traunstein

84918

Institut Sainte Catherine, Avignon

86150

Hämatologie Onkologie im Zentrum MVZ GmbH, Augsburg

89075

Universitätsklinikum Ulm Am Michelsberg, Ulm

90806

Todd Cancer Institute at Long Beach Memorial Medical Center, Long Beach

91031

Shaare Zedek Medical Center, Jerusalem

91054

Universitätsklinikum Erlangen, Erlangen

92120

Kaiser Permanente - San Diego, San Diego

92210

Centre Rene Huguenin, Saint-Cloud

92705

Breastlink Medical Group Inc, Santa Ana

92868

Chao Family Comprehensive Cancer Center, Orange

94304

Stanford University Medical Center, Palo Alto

94589

Kaiser Permanente - Vallejo, Vallejo

94805

Institut Gustave Roussy, Villejuif

97080

Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker, Würzburg

97225

Columbia River Oncology Program, Portland

98029

Swedish Cancer Institute - Issaquah, Issaquah

99204

Cancer Care Northwest, Spokane

99508

Providence Alaska Medical Center, Anchorage

99734

MVZ Nordhausen gGmbH, Praxis Dr. Grafe, Nordhausen

130021

the First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

250117

Shandong Cancer Hospital, Jinan

510060

Sun Yet-sen University Cancer Center, Guangzhou

510080

Guangdong General Hospital, Guangzhou

4941492

Rabin MC, Petah Tikva

7610001

Kaplan Medical Center, Rehovot

8410101

Soroka Medical Center, Beersheba

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

06510-3221

Yale Cancer Center, New Haven

33612-9497

Moffitt Cancer Center, Tampa

04412

Cancer Care of Maine, Brewer

04074

New England Cancer Specialists, Scarborough

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

07871-1791

Sparta Cancer Center, Sparta

28204-2839

Carolinas Medical Center, Charlotte

58122-9988

Sanford Roger Maris Cancer Center, Fargo

37916-2305

Thompson Cancer Survival Center, Knoxville

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

S2000KZE

Instituto de Oncología de Rosario, Rosario

80530-010

Iop Instituto de Oncologia Do Parana, Curitiba

96015-280

UPCO - Unidade de Pesquisas Clínicas em Oncologia, Pelotas

90035-001

Hospital Moinhos de Vento, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

14784-400

Hospital de Cancer de Barretos, Barretos

01236-030

Instituto de Ensino e Pesquisa Sao Lucas - IEP, São Paulo

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

01317-000

Hospital Perola Byington, São Paulo

20560-120

Instituto Nacional de Cancer - INCa, Rio de Janeiro

22290-160

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

T2N 4N2

Arthur J.E. Child Comprehensive Cancer Center, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V3V 1Z2

BC Cancer ? Surrey, Surrey

V5Z 4E6

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre, Vancouver

N6A 4L6

London Regional Cancer Centre, London

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 1Z5

Princess Margaret Cancer Center, Toronto

J4V 2H1

CSSS champlain - Charles-Le Moyne, Greenfield Park

H2X 3E4

Centre Hospitalier de l?Université de Montréal (CHUM), Montreal

H3T 1E2

Jewish General Hospital, Montreal

H4A 3J1

McGill University Health Centre - Glen Site, Montreal

G1J 1Z4

Hopital du Saint Sacrement, Québec

Unknown

Hospital Pablo Tobon Uribe, Medellin-Antioquia

Oncomedica S.A., Montería

Pamela Youde Nethersole Eastern Hospital, Hong Kong

Cork Uni Hospital, Cork

Galway Uni Hospital, Galway

University Hospital Limerick - Oncology, Limerick

Centro Medico Monte Carmelo, Arequipa

Wits Donald Gordon Clinical Trial Centre, Parktown

500 05

Fakultni Nemocnice Hradec Kralove, Hradec Králové

779 00

Fakultni nemocnice Olomouc, Olomouc

128 08

Vseobecna fakultni nemocnice v Praze, Prague

01012

Centre Hospitalier Fleyriat, Bourg-en-Bresse

06097

Universitätsklinikum Halle (Saale), Halle

06110

Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe, Halle

01009

Centro Oncológico Sixtino / Centro Oncológico SA, Guatemala City

01015

Grupo Angeles, Guatemala City

00128

Policlinico Universitario Campus Biomedico, Rome

00189

Az. Osp. Sant'Andrea, Rome

06760

Hospital Angeles Metropolitano, Mexico City

0832

The Panama Clinic, Panama City

0834-02723

Centro Oncologico America, Panama City

04001

Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud, Arequipa

Callao 2

Hospital IV Alberto Sabogal Sologuren, Bellavista

Lima 41

Clinica San Borja, Lima

0081

Private Oncology Centre, Pretoria

08036

Hospital Clínic i Provincial, Barcelona

801 87

Gävle Sjukhus, Gävle

00112

Veterans General Hospital, Taipei

B15 2TH

University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital, Birmingham

BD9 6RJ

Bradford Royal Infirmary, Bradford

BS2 8ED

Bristol Haematology and Oncology centre, Bristol

HU16 5JG

Castle Hill Hospital, Cottingham

EX31 4JB

North Devon District Hospital, Devon

DD1 9SY

Ninewells Hospital, Dundee

HD3 3EA

Huddersfield Royal Infirmary, Huddersfield

LS9 7TF

Leeds Teaching Hosp NHS Trust, Leeds

SE1 7EH

St Thomas Hospital, London

W6 8RF

Charing Cross Hospital, London

M2O 4BX

Christie Hospital Nhs Trust, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

S10 2SJ

Weston Park Hospital, Sheffield

TR1 3LJ

Royal Cornwall Hospital, Truro

All Listed Sponsors
collaborator

NSABP Foundation Inc

NETWORK

collaborator

GBG Forschungs GmbH

OTHER

lead

Hoffmann-La Roche

INDUSTRY

NCT01772472 - 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) | Biotech Hunter | Biotech Hunter