A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
NCT ID: NCT01702571
Last Updated: 2022-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2185 participants
INTERVENTIONAL
2012-11-27
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trastuzumab Emtansine (All Participants)
This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Trastuzumab Emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Trastuzumab Emtansine (Asian Participants)
This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Trastuzumab Emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Interventions
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Trastuzumab Emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed invasive breast cancer
* Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent
* Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy
* Measurable and/or non-measurable disease
* Left ventricular ejection fraction (LVEF) \>/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
* Adequate organ function
* Use of highly effective contraception as defined by the protocol
Exclusion Criteria
* Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
* Peripheral neuropathy of Grade \>/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer
* History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
* History of exposure to cumulative doses of anthracyclines
* History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade \</=1) prior to first study treatment.
* Metastatic central nervous system (CNS) disease only
* Brain metastases which are symptomatic
* History of a decrease in LVEF to less than (\<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
* History of symptomatic CHF (New York Heart Association \[NYHA\] Classes II-IV) or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction or unstable angina within 6 months of first study treatment
* Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
* Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)
* Pregnancy or lactation
* Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
* History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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CEMIC
Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
Hospital Privado De Comunidad; General Practice
Mar del Plata, , Argentina
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research
North Sydney, New South Wales, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia
Westmead Hospital; Medical Oncology and Pallative Care
Westmead, New South Wales, Australia
Haematology & Oncology Clinics of Australia Research Centre
South Brisbane, Queensland, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, Australia
Sunshine Hospital; Oncology Research
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, , Austria
Institut Jules Bordet
Anderlecht, , Belgium
UZ Brussel
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
GHdC Site Notre Dame
Charleroi, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Clinique Ste-Elisabeth
Namur, , Belgium
Sint Augustinus Wilrijk, Apotheek
Wilrijk, , Belgium
*X*Instituto Nacional do Cancer - INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, Brazil
Hospital Sirio Libanes; Centro de Oncologia
São Paulo, São Paulo, Brazil
Hospital Sao Jose
São Paulo, São Paulo, Brazil
MHAT Serdika; Department of medical oncology
Sofia, , Bulgaria
SHATO - Sofia
Sofia, , Bulgaria
SHATOD - Sofia
Sofia, , Bulgaria
District Oncology Dispensary Wit Stationary
Varna, , Bulgaria
BC Cancer - Surrey
Surrey, British Columbia, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Dr. H. Bliss Murphy Cancer Centre; Oncology
St. John's, Newfoundland and Labrador, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Southlake Regional Health Center; Community Care Clinic / Oncology
Newmarket, Ontario, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Sun Yat-sen Memorial Hospital
Guangzhou, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Cancer Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Tianjin Cancer Hospital
Tianjin, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, , Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, , Denmark
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerød, , Denmark
Rigshospitalet; Onkologisk Klinik
København Ø, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, , Denmark
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
Roskilde, , Denmark
Vejle Sygehus; Onkologisk Afdeling
Vejle, , Denmark
Hospital Metropolitano de Santiago
Santiago de los Caballeros, , Dominican Republic
Clinica Alcivar, torre 1;Private office
Guayaquil, , Ecuador
Hospital Solca Portoviejo; Oncologia
Portoviejo, , Ecuador
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, , Estonia
Helsingin yliopistollinen keskussairaala
Helsinki, , Finland
KYS Sadesairaala; Syopatautien poliklinikka
Kuopio, , Finland
Tampere University Hospital; Dept of Oncology
Tampere, , Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, , Finland
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, , France
ICO Paul Papin; Oncologie Medicale.
Angers, , France
Institut Sainte Catherine
Avignon, , France
Hopital Jean Minjoz - CHU de Besançon
Besançon, , France
Clinique Tivoli; Chimiotherapie Radiotherapie
Bordeaux, , France
Institut Bergonie; Oncologie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, , France
Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie
Boulogne-Billancourt, , France
Hopital Morvan; Oncologie - Radiotherapie
Brest, , France
Centre Francois Baclesse; Radiotherapie
Caen, , France
Centre Jean Perrin; Oncologie
Clermont-Ferrand, , France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, , France
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, , France
Centre Hartmann
Levallois-Perret, , France
Centre Oscar Lambret; Senologie
Lille, , France
Clinique Chenieux; Oncology
Limoges, , France
Ch Bretagne Sud Site Scorff; Oncologie Medicale
Lorient, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, , France
Hopital Layne; Medecine Ambulatoire
Mont-de-Marsan, , France
Centre Val Aurelle Paul Lamarque; Recherche Clinique
Montpellier, , France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, , France
Institut Curie; Oncologie Medicale
Paris, , France
HOPITAL TENON; Cancerologie Medicale
Paris, , France
Centre Catalan D' Oncologie
Perpignan, , France
Polyclinique Francheville; Med Chimiotherapie Radiotherapie
Périgueux, , France
Clinique Armoricaine Radiologie; Hopital de Jour
Plérin, , France
Pole Regional De Cancerologie
Poitiers, , France
Institut Jean Godinot; Oncologie Medicale
Reims, , France
Polyclinique De Courlancy; Centre Radiotherapie Oncologie
Reims, , France
Centre Eugene Marquis; Unite Huguenin
Rennes, , France
Centre Henri Becquerel; Oncologie Medicale
Rouen, , France
Centre Rene Huguenin; CONSULT SPECIALISEES
Saint-Cloud, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, , France
Clinique Pasteur; Oncologie Medicale
Toulouse, , France
Centre Henry S Kaplan - CHU Bretonneau ; service oncologie
Tours, , France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy; Pathologie Mammaire
Villejuif, , France
Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter
Augsburg, , Germany
Praxis Dres. Schilling & Till
Berlin, , Germany
Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.
Bottrop, , Germany
Onkozentrum Dres. Göhler
Dresden, , Germany
Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze
Erfurt, , Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, , Germany
OncoResearch Lerchenfeld GmbH
Hamburg, , Germany
HOPA MVZ GmbH
Hamburg, , Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, , Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz
Koblenz, , Germany
Klinikum Leverkusen; Med. Klinik III / Onkologie
Leverkusen, , Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
München, , Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, , Germany
Praxis für Hämatologie und Onkologie
Porta Westfalica, , Germany
Universitaetsfrauenklinik; Und Poliklinik Am Klinikum
Rostock, , Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, , Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
Wiesbaden, , Germany
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg, , Germany
University General Hospital of Heraklion
Crete, , Greece
Uni Hospital of Ioannina; Oncology Dept.
Ioannina, , Greece
University Hospital of Patras Medical Oncology
Pátrai, , Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, , Greece
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, , Guatemala
Princess Margaret Hospital; Oncology
Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, , Hong Kong
Ogyi, Orszagos Gyogyszereszeti Intezet
Budapest, , Hungary
Szent Imre Hospital; Dept. of Oncology
Budapest, , Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, , Hungary
Kaposi Mor County Hospital; Dept. of Oncology
Kaposvár, , Hungary
Landspitali University Hospital, Department of Medical Oncology
Reykjavik, , Iceland
Cipto Mangunkusumo General Hospital; Hematology & Oncology
Jakarta, , Indonesia
Dharmais National Cancer Center
Jakarta, , Indonesia
MRCCC Siloam Semanggi Hospital
Jakarta, , Indonesia
Cork Uni Hospital; Oncology Dept
Cork, , Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin, , Ireland
Mater Misericordiae Uni Hospital; Oncology
Dublin, , Ireland
University Hospital Limerick - Oncology
Limerick, , Ireland
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli, Campania, Italy
Ospedale Bellaria; U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, Italy
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
Piacenza, Emilia-Romagna, Italy
RCCS - Centro di Riferimento; Oncologia Medica B
Aviano (PN), Friuli Venezia Giulia, Italy
Divisione Onc Med dell'Azienda
Udine, Friuli Venezia Giulia, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Rome, Lazio, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, Italy
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona, Lombardy, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, Italy
Ospedale San Raffaele; Medical Oncology
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milan, Lombardy, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
Pavia, Lombardy, Italy
Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico
Sesto San Giovanni (MI), Lombardy, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piedmont, Italy
Ospedale Maggiore Della Carita; Oncologia Medica
Novara, Piedmont, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Turin, Piedmont, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicily, Italy
A.O.U Careggi
Florence, Tuscany, Italy
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
Pontedera, Tuscany, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, Italy
Ospedale Civile; Oncologia Medica
Camposampiero, Veneto, Italy
Ospedale Busonera; Oncologia Medica
Padua, Veneto, Italy
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona, Veneto, Italy
CHL Hopital Municipal; Oncology
Luxembourg, , Luxembourg
Hospital General de México
Mexico City, Mexico CITY (federal District), Mexico
Medica Sur Centro Oncologico Integral
D.F., , Mexico
Hospital Hmg Coyoacan
DF, , Mexico
CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología
Mexico City, , Mexico
Inst. Nacional de Cancerologia; Investigacion Clinica
Mexico City, , Mexico
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Mexico City, , Mexico
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Deventer Ziekenhuis; Interne Geneeskunde
Deventer, , Netherlands
Ziekenhuisgroep Twente, Hengelo
Hengelo, , Netherlands
Spaarne Ziekenhuis; Inwendige Geneeskunde
Hoofddorp, , Netherlands
Medisch Centrum Leeuwarden; Interne
Leeuwarden, , Netherlands
Orbis Medisch Centrum; Inwendige Geneeskunde
Sittard-Geleen, , Netherlands
MC Haaglanden; Oncologie
The Hague, , Netherlands
Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde
Tilburg, , Netherlands
Oslo Universitetssykehus HF; Ullevål sykehus
Oslo, , Norway
Centro Hemato Oncologico Panama
Panama City, , Panama
Centro Oncologico America
Panama City, , Panama
Instituto;Oncologico Miraflores
Lima, , Peru
Clinica de Especialidades Medicas
Lima, , Peru
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, , Poland
Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol
Brzozów, , Poland
Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
Kielce, , Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, , Poland
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, , Poland
IPO de Lisboa; Servico de Oncologia Medica
Lisbon, , Portugal
Hospital da Luz; Departamento de Oncologia Medica
Lisbon, , Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, , Portugal
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
Bratislava, , Slovakia
Fakultna nemocnica Trencín; Onkologicke odd.
Trenčín, , Slovakia
Institute of Oncology Ljubljana
Ljubljana, , Slovenia
Kyungpook National University Medical Center
Daegu, , South Korea
Gachon Medical School Gil Medical Center; Medical Oncology
Incheon, , South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, , South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, , South Korea
Korea University Anam Hospital; Oncology Haemotology
Seoul, , South Korea
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain
Hospital General de Elda; Servicio de Oncologia
Elda, Alicante, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain
Hospital de Jerez de la Frontera; Servicio de Oncologia
Jerez de la Frontera, Cadiz, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Hospital de Donostia; Servicio de Oncologia Medica
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Severo Ochoa; Servicio de Oncologia
Leganés, Madrid, Spain
Hospital Quiron de Madrid; Servicio de Oncologia
Pozuelo de Alarcón, Madrid, Spain
Hospital Xeral Cíes; Servicio de Oncologia
Vigo, Pontevedra, Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, , Spain
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante, , Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, , Spain
Hospital Quiron Barcelona; Servicio de Oncologia
Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, , Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
Girona, , Spain
Hospital Universitario San Cecilio; Servicio de Oncologia
Granada, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, , Spain
Complejo Hospitalario de Pontevedra; Servicio de Oncologia
Pontevedra, , Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, , Spain
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm, , Sweden
Norrlands universitetssjukhus; Onkologkliniken
Umeå, , Sweden
National Cheng Kung Uni Hospital; Surgery
Tainan City, , Taiwan
Chi-Mei Medical Centre; Hematology & Oncology
Tainan City, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, , Taiwan
Department of Surgery, King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, , Thailand
Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, , Turkey (Türkiye)
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, , Turkey (Türkiye)
Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T
Istanbul, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Istanbul Uni of Medicine Faculty; Oncology Dept
Istanbul, , Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
Istanbul, , Turkey (Türkiye)
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, , Turkey (Türkiye)
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, , Turkey (Türkiye)
Dokuz Eylul Uni ; Medical Oncology
Izmir, , Turkey (Türkiye)
Kocaeli University Faculty of Medicine; Medical oncology
İzmit, , Turkey (Türkiye)
Tawam Hospital
Al Ain City, , United Arab Emirates
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
University Hospital Birmingham Queen Elizabeth Hospital
Birmingham, , United Kingdom
Kent & Canterbury Hospital
Canterbury, , United Kingdom
University Hospital coventry; Oncology Department
Coventry, , United Kingdom
Eastborne District General Hospital
Eastbourne, , United Kingdom
Western General Hospital; Clinical Oncology
Edinburgh, , United Kingdom
St Margaret'S Hospital; Breast Unit
Epping, , United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Diana Princess of Wales Hosp.
Grimsby, , United Kingdom
Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
Hull, , United Kingdom
Ipswich Hospital; Oncology Pharmacy
Ipswich, , United Kingdom
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
Lancaster, , United Kingdom
Royal Free Hospital; Dept of Oncology
London, , United Kingdom
Guys & St Thomas Hospital; Department of Oncology
London, , United Kingdom
St George'S Hospital; Oncology Research Office /Oncology Opd
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone, , United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, , United Kingdom
Mount Vernon Hospital
Middlesex, , United Kingdom
Plymouth Oncology Centre; Clinical Trials Unit
Plymouth, , United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth, , United Kingdom
Queen's Hospital; Oncology
Romford, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Singleton Hospital; Pharmacy
Swansea, , United Kingdom
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, , United Kingdom
York District Hospital
York, , United Kingdom
Unidad de Mastologia y Atencion a la Mujer
Barcelona, , Venezuela
Instituto Oncológico Luis Razetti
Caracas, , Venezuela
Instituto de Oncologia y Hematologia UCV
Caracas, , Venezuela
Countries
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References
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Wuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7.
Engebraaten O, Yau C, Berg K, Borgen E, Garred O, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z.
Montemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Pena-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-001628-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO28231
Identifier Type: -
Identifier Source: org_study_id
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