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 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
2 other identifiers
interventional
1,486
27 countries
266
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Apr 2013
Longer than P75 for phase_3 breast-cancer
266 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedStudy Start
First participant enrolled
April 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2018
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2024
CompletedJuly 22, 2025
June 1, 2025
5.3 years
January 17, 2013
July 24, 2019
July 2, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
At Year 3
Secondary Outcomes (26)
IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years
At Year 3
IDFS Including SPNBC Rate at 7 Years
At Year 7
IDFS Including SPNBC Rate at 8 Years
At Year 8
Disease-free Survival (DFS) Rate at 3 Years
At Year 3
DFS Rate at 7 Years
At Year 7
- +21 more secondary outcomes
Other Outcomes (2)
IDFS Rate at 7 Years
At Year 7
IDFS Rate at 8 Years
At Year 8
Study Arms (2)
Trastuzumab
ACTIVE COMPARATORTrastuzumab emtansine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- NSABP Foundation Inccollaborator
- GBG Forschungs GmbHcollaborator
Study Sites (268)
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Kaiser Permanente - San Diego
San Diego, California, 92120, United States
Breastlink Medical Group Inc
Santa Ana, California, 92705, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente - Franklin
Denver, Colorado, 80205, United States
Colorado Cancer Research Program/Admin
Denver, Colorado, 80222, United States
Yale Cancer Center
New Haven, Connecticut, 06510-3221, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
UF Health Orlando
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612-9497, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Edward Cancer Center Naperville
Naperville, Illinois, 60540, United States
Edward Cancer Center Plainfield
Plainfield, Illinois, 60585, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Norton Healthcare Inc.
Louisville, Kentucky, 40202, United States
Cancer Care of Maine
Brewer, Maine, 04412, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Med Star Franklin Square Medical Center/Weinburg Cancer Institute
Baltimore, Maryland, 21237, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Breslin Cancer Center
Lansing, Michigan, 48910, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
US oncology research at Minnesota Oncology
Saint Louis Park, Minnesota, 55426, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Sparta Cancer Center
Sparta, New Jersey, 07871-1791, United States
Columbia University Medical Center
New York, New York, 10032, United States
Troy Cancer Treatment Program
Troy, New York, 12180, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204-2839, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122-9988, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Fairview Hospital
Cleveland, Ohio, 44111, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University, Arthur James Cancer Hospital
Columbus, Ohio, 43210, United States
Columbia River Oncology Program
Portland, Oregon, 97225, United States
Kimmel Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212, United States
Uni of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
York Hospital
York, Pennsylvania, 17403, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916-2305, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Hospital Outpatient Center
Houston, Texas, 77030, United States
Uni of Texas - Md Anderson Cancer Center
Houston, Texas, 77030, United States
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, 79410, United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22408, United States
Centra Alan B. Pearson Regional Cancer Center
Lynchburg, Virginia, 24501, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298, United States
Swedish Cancer Institute - Issaquah
Issaquah, Washington, 98029, United States
Cancer Care Northwest
Spokane, Washington, 99204, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, 6020, Austria
Lkh Salzburg - Univ. Klinikum Salzburg
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
CHU de Liège (Sart Tilman)
Liège, 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Iop Instituto de Oncologia Do Parana
Curitiba, Paraná, 80530-010, Brazil
UPCO - Unidade de Pesquisas Clínicas em Oncologia
Pelotas, Rio Grande do Sul, 96015-280, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
São Paulo, São Paulo, 01236-030, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, 22290-160, Brazil
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer ? Surrey
Surrey, British Columbia, V3V 1Z2, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5, Canada
CSSS champlain - Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1J 1Z4, Canada
the First Hospital of Jilin University
Changchun, 130021, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
Guangdong General Hospital
Guangzhou, 510080, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Cancer Hospital
Jinan, 250117, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Clinica del Country
Bogotá, 11001, Colombia
Hospital Pablo Tobon Uribe
Medellin-Antioquia, Colombia
Oncomedica S.A.
Montería, Colombia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Institut Sainte Catherine
Avignon, 84918, France
Hopital Jean Minjoz
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, 01012, France
Centre Francois Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre de Cancerologie de la Sarthe, Clinique Victor HugoSoReCOH
Le Mans, 72000, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Val Aurelle Paul Lamarque
Montpellier, 34298, France
Institut Curie
Paris, 75231, France
Hopital Saint Louis
Paris, 75475, France
Hopital Tenon
Paris, 75970, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Rene Huguenin
Saint-Cloud, 92210, France
Centre Paul Strauss
Strasbourg, 67065, France
Institut Gustave Roussy
Villejuif, 94805, France
Hämatologie Onkologie im Zentrum MVZ GmbH
Augsburg, 86150, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125, Germany
Studienzentrum Berlin City
Berlin, 14169, Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, 33604, Germany
Klinikum Sindelfingen-Böblingen
Böblingen, 71032, Germany
St. Elisabeth Krankenhaus Köln GmbH
Cologne, 50935, Germany
Kliniken der Stadt Köln gGmbH Krankenhaus Holweide
Cologne, 51067, Germany
St. Johannes-Hospital
Dortmund, 44137, Germany
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
Düsseldorf, 40235, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, 60596, Germany
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main, 60389, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Evangelische Kliniken Gelsenkirchen GmbH
Gelsenkirchen, 45879, Germany
Universitätsklinikum Greifswald
Greifswald, 17475, Germany
Universitätsklinikum Halle (Saale)
Halle, 06097, Germany
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
Halle, 06110, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, 20357, Germany
St. Barbara-Klinik Hamm-Heessen GmbH
Hamm, 59073, Germany
Diakovere Henriettenstift, Frauenklinik
Hanover, 30559, Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hanover, 30625, Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120, Germany
Elisabeth-Krankenhaus Brustzentrum
Kassel, 34117, Germany
Klinikum Kassel GmbH
Kassel, 34125, Germany
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel, 24105, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
Lebach, 66822, Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Lichtenberg, 10367, Germany
Klinikum der Universität München
München, 80337, Germany
Medizinisches Zentrum für Hämatologie und Onkologie
München, 80639, Germany
MVZ Nordhausen gGmbH, Praxis Dr. Grafe
Nordhausen, 99734, Germany
Sana Klinikum Offenbach GmbH
Offenbach, 63069, Germany
St. Vincenz-Krankenhaus Paderborn
Paderborn, 33098, Germany
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
Recklinghausen, 45659, Germany
Klinikum am Steinenberg Frauenklinik
Reutlingen, 72764, Germany
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
Rostock, 18059, Germany
Gynäkologie Kompetenzzentrum
Stralsund, 18439, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
Traunstein, 83278, Germany
Universitätsklinik Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm Am Michelsberg
Ulm, 89075, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199, Germany
Marien-Hospital Witten
Witten, 58452, Germany
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg, 97080, Germany
Univ General Hosp Heraklion
Heraklion, 71110, Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, 54645, Greece
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, 01009, Guatemala
Grupo Angeles
Guatemala City, 01015, Guatemala
Queen Mary Hospital
Hong Kong, 852, Hong Kong
Tuen Mun Hospital
Hong Kong, 852, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Cork Uni Hospital
Cork, Ireland
St Vincent'S Uni Hospital
Dublin, 4, Ireland
Mater Misericordiae Uni Hospital
Dublin, 7, Ireland
Beaumont Hospital
Dublin, 9, Ireland
Galway Uni Hospital
Galway, Ireland
University Hospital Limerick - Oncology
Limerick, Ireland
Soroka Medical Center
Beersheba, 8410101, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Rabin MC
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Ospedale Antonio Perrino
Brindisi, Apulia, 72100, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Università degli Studi Federico II
Napoli, Campania, 80131, Italy
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138, Italy
Ausl Di Bologna-Ospedale Bellaria
Bologna, Emilia-Romagna, 40139, Italy
Policlinico Universitario Campus Biomedico
Rome, Lazio, 00128, Italy
Az. Osp. Sant'Andrea
Rome, Lazio, 00189, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
Genoa, Liguria, 16132, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, 24127, Italy
Asst Di Cremona
Cremona, Lombardy, 26100, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Asst Di Monza
Monza, Lombardy, 20052, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, 10060, Italy
Azlenda Ospendaliero-Universitaria Pisana
Pisa, Tuscany, 56100, Italy
Azienda usl 5 Di Pisa-Ospedale Di Pontedera
Pontedera, Tuscany, 56025, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padua, Veneto, 35128, Italy
A.O.U.I. Verona-Ospedale Borgo Trento
Verona, Veneto, 37126, Italy
Hospital Angeles Metropolitano
Mexico City, Mexico CITY (federal District), 06760, Mexico
Médicos Especialistas en Cáncer SC
Aguascalientes, 20230, Mexico
Instituto Nacional de Cancerologia
Distrito Federal, 14080, Mexico
Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
Mexico City, 14080, Mexico
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
The Panama Clinic
Panama City, 0832, Panama
Centro Oncologico America
Panama City, 0834-02723, Panama
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud
Arequipa, 04001, Peru
Centro Medico Monte Carmelo
Arequipa, Peru
Hospital IV Alberto Sabogal Sologuren
Bellavista, Callao 2, Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, 13, Peru
Clinica San Borja
Lima, Lima 41, Peru
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Oncology Institute of Vojvodina
Kamenitz, 21204, Serbia
Cape Town Oncology Trials
Cape Town, 7570, South Africa
Medical Oncology Centre of Rosebank
Johannesburg, 2196, South Africa
Wits Donald Gordon Clinical Trial Centre
Parktown, South Africa
Hopelands Cancer Centre
Pietermaritzburg, 3201, South Africa
Cancercare
Port Elizabeth, 6045, South Africa
Private Oncology Centre
Pretoria, 0081, South Africa
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital de Navarra
Navarra, Navarre, 31008, Spain
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital Clínic i Provincial
Barcelona, 08036, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Instituto Valenciano Oncologia
Valencia, 46009, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Gävle Sjukhus
Gävle, 801 87, Sweden
Skånes University Hospital, Skånes Department of Onclology
Lund, 22185, Sweden
Karolinska Hospital
Stockholm, 17176, Sweden
Kantonsspital Aarau AG Medizin Onkologie
Aarau, 5001, Switzerland
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Zurich, 8008, Switzerland
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Veterans General Hospital
Taipei, 00112, Taiwan
National Taiwan Uni Hospital
Taipei, 100, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, 333, Taiwan
Uludag Uni Hospital
Bursa, 16059, Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, 22770, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, 34000, Turkey (Türkiye)
Ege Uni Medical Faculty Hospital
Izmir, 35100, Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, 44280, Turkey (Türkiye)
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Bristol Haematology and Oncology centre
Bristol, BS2 8ED, United Kingdom
Castle Hill Hospital
Cottingham, HU16 5JG, United Kingdom
North Devon District Hospital
Devon, EX31 4JB, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
Leeds Teaching Hosp NHS Trust
Leeds, LS9 7TF, United Kingdom
St Thomas Hospital
London, SE1 7EH, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Christie Hospital Nhs Trust
Manchester, M2O 4BX, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Related Publications (2)
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.
PMID: 39813643DERIVEDvon 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.
PMID: 30516102DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
April 3, 2013
Primary Completion
July 25, 2018
Study Completion
May 23, 2024
Last Updated
July 22, 2025
Results First Posted
October 1, 2019
Record last verified: 2025-06