Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: NSABP Foundation Inc
name: GBG Forschungs GmbH
First posted: 2013-01-21
Enrollment: 1487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Invasive Disease-free Survival (IDFS)
timeFrame: From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)
Secondary outcomes:
measure: Invasive Disease-free Survival Including Second Primary Non-breast Cancer
timeFrame: From baseline up to 12 years
measure: Disease-free Survival
timeFrame: From baseline up to 12 years
measure: Overall Survival (OS)
timeFrame: Baseline up to 12 years
measure: Distant Recurrence-Free Interval (DRFI)
timeFrame: Baseline up to 12 years
measure: Percentage of Participants With Adverse Events
timeFrame: From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)
measure: Percentage of Participants With Cardiac Dysfunction
timeFrame: From baseline up to 12 years
measure: Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
timeFrame: Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12
measure: Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
timeFrame: Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12
measure: Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1)
timeFrame: Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination
measure: Serum Concentrations (AUC) of Trastuzumab
timeFrame: C1D1 and C4D1 of post-infusion and study treatment termination
measure: Plasma Concentrations of DM1
timeFrame: Day 1 on Cycles 1 and 4. Each cycle is 21 days.
measure: Trastuzumab Emtansine Exposure
timeFrame: Day 1 on Cycles 1, 2, 4 and 5, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
measure: Anti-trastuzumab Emtansine Antibody (ATA)
timeFrame: Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
measure: Anti-trastuzumab Antibody (ATA)
timeFrame: Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Long Beach
country: United States
facility: Todd Cancer Institute at Long Beach Memorial Medical Center
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente - San Diego
state: California
city: Santa Ana
country: United States
facility: Breastlink Medical Group Inc
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Denver
country: United States
facility: Kaiser Permanente - Franklin
state: Colorado
city: Denver
country: United States
facility: Colorado Cancer Research Program/Admin
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: UF Health Orlando
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Naperville
country: United States
facility: Edward Cancer Center Naperville
state: Illinois
city: Plainfield
country: United States
facility: Edward Cancer Center Plainfield
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare Inc.
state: Kentucky
city: Brewer
country: United States
facility: Cancer Care of Maine
state: Maine
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Med Star Franklin Square Medical Center/Weinburg Cancer Institute
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Lansing
country: United States
facility: Breslin Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Louis Park
country: United States
facility: US oncology research at Minnesota Oncology
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Sparta
country: United States
facility: Sparta Cancer Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Troy
country: United States
facility: Troy Cancer Treatment Program
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University, Arthur James Cancer Hospital
state: Ohio
city: Portland
country: United States
facility: Columbia River Oncology Program
state: Oregon
city: Philadelphia
country: United States
facility: Kimmel Cancer Center Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Uni of Pittsburgh
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital Outpatient Center
state: Texas
city: Houston
country: United States
facility: Uni of Texas - Md Anderson Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research & Treatment Center
state: Texas
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg, Inc.
state: Virginia
city: Lynchburg
country: United States
facility: Centra Alan B. Pearson Regional Cancer Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University - Massey Cancer Center
state: Virginia
city: Issaquah
country: United States
facility: Swedish Cancer Institute - Issaquah
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Curitiba
country: Brazil
facility: Iop Instituto de Oncologia Do Parana
state: Paraná
city: Pelotas
country: Brazil
facility: UPCO - Unidade de Pesquisas Clínicas em Oncologia
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa
city: Rio De Janeiro
country: Brazil
facility: Clinicas Oncologicas Integradas - COI
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Surrey
country: Canada
facility: BC Cancer ? Surrey
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Greenfield Park
country: Canada
facility: CSSS champlain - Charles-Le Moyne
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l?Université de Montréal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Bogota
country: Colombia
facility: Clinica del Country
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat
city: Caen
country: France
facility: Centre Francois Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Le Mans
country: France
facility: Centre de Cancerologie de la Sarthe, Clinique Victor HugoSoReCOH
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Centre Val Aurelle Paul Lamarque
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Tenon
city: Rouen
country: France
facility: Centre Henri Becquerel
city: St Cloud
country: France
facility: Centre Rene Huguenin
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Augsburg
country: Germany
facility: Hämatologie Onkologie im Zentrum MVZ GmbH
city: Berlin-Lichtenberg
country: Germany
facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Studienzentrum Berlin City
city: Bielefeld
country: Germany
facility: Onkologische Schwerpunktpraxis Bielefeld
city: Böblingen
country: Germany
facility: Klinikum Sindelfingen-Böblingen
city: Dortmund
country: Germany
facility: St. Johannes-Hospital
city: Düsseldorf
country: Germany
facility: Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Essen
country: Germany
facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Frankfurt am Main
country: Germany
facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gelsenkirchen
country: Germany
facility: Evangelische Kliniken Gelsenkirchen GmbH
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Halle
country: Germany
facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
city: Hamburg
country: Germany
facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm-Heessen GmbH
city: Hannover
country: Germany
facility: Diakovere Henriettenstift, Frauenklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT)
city: Kassel
country: Germany
facility: Elisabeth-Krankenhaus Brustzentrum
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
city: Kiel
country: Germany
facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
city: Koeln
country: Germany
facility: St. Elisabeth Krankenhaus Köln GmbH
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide
city: Lebach
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
city: München
country: Germany
facility: Klinikum der Universität München
city: München
country: Germany
facility: Medizinisches Zentrum für Hämatologie und Onkologie
city: Nordhausen
country: Germany
facility: MVZ Nordhausen gGmbH, Praxis Dr. Grafe
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus Paderborn
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
city: Reutlingen
country: Germany
facility: Klinikum am Steinenberg Frauenklinik
city: Rostock
country: Germany
facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
city: Stralsund
country: Germany
facility: Gynäkologie Kompetenzzentrum
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Traunstein
country: Germany
facility: Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Am Michelsberg
city: Wiesbaden
country: Germany
facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden
city: Witten
country: Germany
facility: Marien-Hospital Witten
city: Würzburg
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Guatemala
country: Guatemala
facility: Centro Oncológico Sixtino / Centro Oncológico SA
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Cork
country: Ireland
facility: Cork Uni Hospital
city: Dublin
country: Ireland
facility: St Vincent'S Uni Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae Uni Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: Galway Uni Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick - Oncology
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Petach Tikva
country: Israel
facility: Rabin MC
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Napoli
country: Italy
facility: Università degli Studi Federico II
state: Campania
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
state: Emilia-Romagna
city: Bologna
country: Italy
facility: Ausl Di Bologna-Ospedale Bellaria
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
state: Lazio
city: Roma
country: Italy
facility: Az. Osp. Sant'Andrea
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
state: Liguria
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII
state: Lombardia
city: Cremona
country: Italy
facility: Asst Di Cremona
state: Lombardia
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
state: Piemonte
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino
state: Puglia
city: Pisa
country: Italy
facility: Azlenda Ospendaliero-Universitaria Pisana
state: Toscana
city: Pontedera
country: Italy
facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Verona
country: Italy
facility: A.O.U.I. Verona-Ospedale Borgo Trento
state: Veneto
city: Mexico City
country: Mexico
facility: Hospital Angeles Metropolitano
state: Mexico CITY (federal District)
city: Aguascalientes
country: Mexico
facility: Médicos Especialistas en Cáncer SC
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Mexico City
country: Mexico
facility: Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Panama City
country: Panama
facility: The Panama Clinic
city: Panama
country: Panama
facility: Centro Oncologico America
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Bellavista
country: Peru
facility: Hospital IV Alberto Sabogal Sologuren
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Lima
country: Peru
facility: Clinica San Borja
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank
city: Parktown
country: South Africa
facility: Wits Donald Gordon Clinical Trial Centre
city: Pietermaritzburg
country: South Africa
facility: Hopelands Cancer Centre
city: Port Elizabeth
country: South Africa
facility: Cancercare
city: Pretoria
country: South Africa
facility: Private Oncology Centre
city: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Vigo
country: Spain
facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro
state: Pontevedra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Navarra
country: Spain
facility: Hospital de Navarra
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Gävle
country: Sweden
facility: Gävle Sjukhus
city: Lund
country: Sweden
facility: Skånes University Hospital, Skånes Department of Onclology
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG Medizin Onkologie
city: Zürich
country: Switzerland
facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou
city: Bursa
country: Turkey
facility: Uludag Uni Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty Hospital
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology centre
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Devon
country: United Kingdom
facility: North Devon District Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hosp NHS Trust
city: London
country: United Kingdom
facility: St Thomas Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.