AzTrials
AzTrials

Breast CancerPhase 3NCT01772472

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)

A Phase 3 study testing trastuzumab and trastuzumab emtansine in people with Breast Cancer, run by Hoffmann-La Roche at 268 sites in 28 countries.

Completed

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

Official record
Search all trials

Trial summary

This 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab and trastuzumab emtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,486 participants
Where
268 sitesin 28 countries
Study dates
3 Apr 2013to 23 May 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

268 sites in 28 countries.

268 sites in 28 countries

United States60 sites

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Med Star Franklin Square Medical Center/Weinburg Cancer Institute

    Baltimore, Maryland, 21237

  • Cancer Care of Maine

    Brewer, Maine, 04412

  • Aultman Hospital

    Canton, Ohio, 44710

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204-2839

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Fairview Hospital

    Cleveland, Ohio, 44111

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University, Arthur James Cancer Hospital

    Columbus, Ohio, 43210

  • Kaiser Permanente - Franklin

    Denver, Colorado, 80205

  • Colorado Cancer Research Program/Admin

    Denver, Colorado, 80222

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122-9988

  • Hematology Oncology Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22408

  • University of Florida

    Gainesville, Florida, 32610

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital Outpatient Center

    Houston, Texas, 77030

  • Uni of Texas - Md Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • Swedish Cancer Institute - Issaquah

    Issaquah, Washington, 98029

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916-2305

  • Breslin Cancer Center

    Lansing, Michigan, 48910

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Todd Cancer Institute at Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Norton Healthcare Inc.

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

  • Centra Alan B. Pearson Regional Cancer Center

    Lynchburg, Virginia, 24501

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Edward Cancer Center Naperville

    Naperville, Illinois, 60540

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Cancer Center

    New Haven, Connecticut, 06510-3221

  • Columbia University Medical Center

    New York, New York, 10032

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • UF Health Orlando

    Orlando, Florida, 32806

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Kimmel Cancer Center Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Uni of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Edward Cancer Center Plainfield

    Plainfield, Illinois, 60585

  • Columbia River Oncology Program

    Portland, Oregon, 97225

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23298

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • US oncology research at Minnesota Oncology

    Saint Louis Park, Minnesota, 55426

  • Kaiser Permanente - San Diego

    San Diego, California, 92120

  • Breastlink Medical Group Inc

    Santa Ana, California, 92705

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sparta Cancer Center

    Sparta, New Jersey, 07871-1791

  • Cancer Care Northwest

    Spokane, Washington, 99204

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9497

  • Troy Cancer Treatment Program

    Troy, New York, 12180

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Germany47 sites

  • Hämatologie Onkologie im Zentrum MVZ GmbH

    Augsburg, 86150

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125

  • Studienzentrum Berlin City

    Berlin, 14169

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

  • Klinikum Sindelfingen-Böblingen

    Böblingen, 71032

  • St. Elisabeth Krankenhaus Köln GmbH

    Cologne, 50935

  • Kliniken der Stadt Köln gGmbH Krankenhaus Holweide

    Cologne, 51067

  • St. Johannes-Hospital

    Dortmund, 44137

  • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

    Düsseldorf, 40235

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45122

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

    Essen, 45136

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Klinik Johann Wolfgang von Goethe Uni

    Frankfurt, 60596

  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

    Frankfurt am Main, 60389

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Evangelische Kliniken Gelsenkirchen GmbH

    Gelsenkirchen, 45879

  • Universitätsklinikum Greifswald

    Greifswald, 17475

  • Universitätsklinikum Halle (Saale)

    Halle, 06097

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

    Halle, 06110

  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

    Hamburg, 20357

  • St. Barbara-Klinik Hamm-Heessen GmbH

    Hamm, 59073

  • Diakovere Henriettenstift, Frauenklinik

    Hanover, 30559

  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

  • Elisabeth-Krankenhaus Brustzentrum

    Kassel, 34117

  • Klinikum Kassel GmbH

    Kassel, 34125

  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

    Kiel, 24105

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

    Lebach, 66822

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

    Lichtenberg, 10367

  • Klinikum der Universität München

    München, 80337

  • Medizinisches Zentrum für Hämatologie und Onkologie

    München, 80639

  • MVZ Nordhausen gGmbH, Praxis Dr. Grafe

    Nordhausen, 99734

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069

  • St. Vincenz-Krankenhaus Paderborn

    Paderborn, 33098

  • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

    Recklinghausen, 45659

  • Klinikum am Steinenberg Frauenklinik

    Reutlingen, 72764

  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

    Rostock, 18059

  • Gynäkologie Kompetenzzentrum

    Stralsund, 18439

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung

    Traunstein, 83278

  • Universitätsklinik Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm Am Michelsberg

    Ulm, 89075

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

  • Marien-Hospital Witten

    Witten, 58452

  • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

    Würzburg, 97080

Other trials in Germany

Italy19 sites

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • Ausl Di Bologna-Ospedale Bellaria

    Bologna, Emilia-Romagna, 40139

  • Ospedale Antonio Perrino

    Brindisi, Apulia, 72100

  • Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

    Candiolo, Piedmont, 10060

  • Asst Di Cremona

    Cremona, Lombardy, 26100

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)

    Genoa, Liguria, 16132

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Asst Di Monza

    Monza, Lombardy, 20052

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Università degli Studi Federico II

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128

  • Azlenda Ospendaliero-Universitaria Pisana

    Pisa, Tuscany, 56100

  • Azienda usl 5 Di Pisa-Ospedale Di Pontedera

    Pontedera, Tuscany, 56025

  • Policlinico Universitario Campus Biomedico

    Rome, Lazio, 00128

  • Az. Osp. Sant'Andrea

    Rome, Lazio, 00189

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

    Verona, Veneto, 37126

Other trials in Italy

France16 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse, 01012

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Cancerologie de la Sarthe, Clinique Victor HugoSoReCOH

    Le Mans, 72000

  • Institut Paoli Calmettes

    Marseille, 13273

  • Centre Val Aurelle Paul Lamarque

    Montpellier, 34298

  • Institut Curie

    Paris, 75231

  • Hopital Saint Louis

    Paris, 75475

  • Hopital Tenon

    Paris, 75970

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Paul Strauss

    Strasbourg, 67065

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom14 sites

  • University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Bristol Haematology and Oncology centre

    Bristol, BS2 8ED

  • Castle Hill Hospital

    Cottingham, HU16 5JG

  • North Devon District Hospital

    Devon, EX31 4JB

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Leeds Teaching Hosp NHS Trust

    Leeds, LS9 7TF

  • St Thomas Hospital

    London, SE1 7EH

  • Charing Cross Hospital

    London, W6 8RF

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

Spain13 sites

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Hospital Severo Ochoa

    Leganés, Madrid, 28911

  • Hospital Universitario La Paz

    Madrid, 28046

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

    Madrid, 28050

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital de Navarra

    Navarra, Navarre, 31008

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona, 43204

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Instituto Valenciano Oncologia

    Valencia, 46009

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Canada12 sites

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CSSS champlain - Charles-Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l?Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Hopital du Saint Sacrement

    Québec, Quebec, G1J 1Z4

  • BC Cancer ? Surrey

    Surrey, British Columbia, V3V 1Z2

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

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

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Brazil10 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Iop Instituto de Oncologia Do Parana

    Curitiba, Paraná, 80530-010

  • UPCO - Unidade de Pesquisas Clínicas em Oncologia

    Pelotas, Rio Grande do Sul, 96015-280

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, 22290-160

  • Instituto de Ensino e Pesquisa Sao Lucas - IEP

    São Paulo, São Paulo, 01236-030

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000

Other trials in Brazil

China7 sites

  • the First Hospital of Jilin University

    Changchun, 130021

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Shandong Cancer Hospital

    Jinan, 250117

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

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

Ireland6 sites

  • Cork Uni Hospital

    Cork

  • St Vincent'S Uni Hospital

    Dublin, 4

  • Mater Misericordiae Uni Hospital

    Dublin, 7

  • Beaumont Hospital

    Dublin, 9

  • Galway Uni Hospital

    Galway

  • University Hospital Limerick - Oncology

    Limerick

Other trials in Ireland

Israel6 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Rabin MC

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

South Africa6 sites

  • Cape Town Oncology Trials

    Cape Town, 7570

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • Wits Donald Gordon Clinical Trial Centre

    Parktown

  • Hopelands Cancer Centre

    Pietermaritzburg, 3201

  • Cancercare

    Port Elizabeth, 6045

  • Private Oncology Centre

    Pretoria, 0081

Other trials in South Africa

Mexico5 sites

  • Médicos Especialistas en Cáncer SC

    Aguascalientes, 20230

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080

  • Hospital Angeles Metropolitano

    Mexico City, Mexico CITY (federal District), 06760

  • Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir

    Mexico City, 14080

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

Other trials in Mexico

Peru5 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud

    Arequipa, 04001

  • Centro Medico Monte Carmelo

    Arequipa

  • Hospital IV Alberto Sabogal Sologuren

    Bellavista, Callao 2

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima, 13

  • Clinica San Borja

    Lima, Lima 41

Other trials in Peru

Taiwan5 sites

  • Taichung Veterans General Hospital

    Taichung, 407

  • Veterans General Hospital

    Taipei, 00112

  • National Taiwan Uni Hospital

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Uludag Uni Hospital

    Bursa, 16059

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi

    Istanbul, 34000

  • Ege Uni Medical Faculty Hospital

    Izmir, 35100

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280

Other trials in Turkey (Türkiye)

Belgium4 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • CHU de Liège (Sart Tilman)

    Liège, 4000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Argentina3 sites

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

Other trials in Argentina

Austria3 sites

  • Tiroler Landeskrankenanstalten Ges.M.B.H.

    Innsbruck, 6020

  • Lkh Salzburg - Univ. Klinikum Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Colombia3 sites

  • Clinica del Country

    Bogotá, 11001

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

  • Oncomedica S.A.

    Montería

Other trials in Colombia

Czechia3 sites

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong, 852

  • Tuen Mun Hospital

    Hong Kong, 852

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

Other trials in Hong Kong

Sweden3 sites

  • Gävle Sjukhus

    Gävle, 801 87

  • Skånes University Hospital, Skånes Department of Onclology

    Lund, 22185

  • Karolinska Hospital

    Stockholm, 17176

Other trials in Sweden

Greece2 sites

  • Univ General Hosp Heraklion

    Heraklion, 71110

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

Guatemala2 sites

  • Centro Oncológico Sixtino / Centro Oncológico SA

    Guatemala City, 01009

  • Grupo Angeles

    Guatemala City, 01015

Other trials in Guatemala

Panama2 sites

  • The Panama Clinic

    Panama City, 0832

  • Centro Oncologico America

    Panama City, 0834-02723

Other trials in Panama

Serbia2 sites

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

Other trials in Serbia

Switzerland2 sites

  • Kantonsspital Aarau AG Medizin Onkologie

    Aarau, 5001

  • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

    Zurich, 8008

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
trastuzumab, trastuzumab emtansine
Medical subject headings
Breast Neoplasms

What participants receive

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

  • trastuzumabDrug

    6 mg/kg intravenously every 3 weeks, 14 cycles

  • trastuzumab emtansineDrug

    3.6 mg/kg intravenously every 3 weeks, 14 cycles

Study groups in NCT01772472
Study groupRoleWhat they receive
TrastuzumabActive comparatorNot described
Receives: Drug: trastuzumab
Trastuzumab emtansineExperimentalNot described
Receives: Drug: trastuzumab emtansine

What is being measured

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

  1. Invasive Disease-free Survival (IDFS) Rate at 3 Years

    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.

    Measured: At Year 3

Secondary outcomes (26)

  1. IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years

    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.

    Measured: At Year 3

  2. IDFS Including SPNBC Rate at 7 Years

    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.

    Measured: At Year 7

  3. IDFS Including SPNBC Rate at 8 Years

    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.

    Measured: At Year 8

  4. Disease-free Survival (DFS) Rate at 3 Years

    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.

    Measured: At Year 3

  5. DFS Rate at 7 Years

    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.

    Measured: At Year 7

  6. DFS Rate at 8 Years

    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.

    Measured: At Year 8

  7. Overall Survival (OS) Rate at 5 Years

    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.

    Measured: At Year 5

  8. OS Rate at 7 Years

    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.

    Measured: At Year 7

  9. OS Rate at 8 Years

    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.

    Measured: At Year 8

  10. Distant Recurrence-free Interval (DRFI) Rate at 3 Years

    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.

    Measured: At Year 3

  11. DRFI Rate at 7 Years

    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.

    Measured: At Year 7

  12. DRFI Rate at 8 Years

    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.

    Measured: At Year 8

  13. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From signing of informed consent till end of follow up (up to approximately 131 months)

  14. Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee

    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.

    Measured: Up to approximately 126 months

  15. Percentage of Participants With Hepatotoxicity Events as Adjudicated by the Hepatic Review Committee

    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.

    Measured: Up to approximately 64 months

  16. Number of Participants Who Discontinued Treatment Due to AEs

    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).

    Measured: Up to approximately 9.6 months

  17. Number of Participants With AEs and SAEs Leading to Death

    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.

    Measured: From signing of informed consent till end of follow up (up to approximately 131 months)

  18. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)

    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.

    Measured: Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)

  19. Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)

    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.

    Measured: Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)

  20. Serum Concentrations of Trastuzumab Emtansine

    Measured: 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)

  21. Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)

    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.

    Measured: Pre-infusion, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days)

  22. Serum Concentrations of Trastuzumab

    Measured: 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)

  23. Serum Concentrations of Total Trastuzumab

    Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm.

    Measured: 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)

  24. Median Duration of Trastuzumab Emtansine Exposure

    Treatment duration was defined as the time between the first and the last infusion of trastuzumab emtansine.

    Measured: Up to 12 months

  25. Number of Participants With Positive Anti-drug Antibodies (ADAs) to Trastuzumab Emtansine

    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.

    Measured: 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])

  26. Number of Participants With Positive ADAs to Trastuzumab

    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.

    Measured: 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])

Timeline

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

  1. First posted21 Jan 2013 (estimated)
  2. Study start3 Apr 2013
  3. Primary completion25 Jul 2018
  4. Study completion23 May 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01772472
Sponsor's protocol ID
BO27938
Other IDs
2012-002018-37
Status last verified
Jun 2025
First submitted
17 Jan 2013
Last updated
22 Jul 2025
Data monitoring committee
Yes

Publications

  • Geyer CE Jr, Untch M, Huang CS, Mano MS, Mamounas EP, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, D'Hondt V, Conlin AK, Guarneri V, Wapnir IL, Jackisch C, Arce-Salinas C, Fasching PA, DiGiovanna MP, Crown JP, Wuelfing P, Shao Z, Rota Caremoli E, Bonnefoi HR, Hennessy BT, Stamatovic L, Castro-Salguero H, Brufsky AM, Knott A, Siddiqui A, Lambertini C, Boulet T, Nyawira B, Restuccia E, Loibl S; KATHERINE Study Group. Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer. N Engl J Med. 2025 Jan 16;392(3):249-257. doi: 10.1056/NEJMoa2406070.

    PubMed 39813643

  • von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.

    PubMed 30516102

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trastuzumab and trastuzumab emtansine in people with Breast Cancer, run by Hoffmann-La Roche at 268 sites in 28 countries.

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

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Germany, Italy, France, United Kingdom and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Invasive Disease-free Survival (IDFS) Rate at 3 Years (time frame: At Year 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01772472, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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