Clinical trial NCT01702571: 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
Official title: A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 2185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.


Eligibility criteria: Inclusion Criteria:

* HER2-positive disease determined locally
* 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:

* History of treatment with trastuzumab emtansine
* 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
timeFrame: Baseline up to approximately 7 years
Secondary outcomes:
measure: Percentage of Participants With Specific AEPIs
timeFrame: Baseline up to approximately 7 years
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to approximately 7 years
measure: Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
timeFrame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
measure: Overall Survival
timeFrame: Baseline until death (up to approximately 7 years)
measure: Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
timeFrame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
measure: Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
timeFrame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
measure: Duration of Response (DOR) According to RECIST v 1.1
timeFrame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
measure: Time to Response According to RECIST v 1.1
timeFrame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
measure: Number of Hospital Visits
timeFrame: Baseline up to approximately 7 years
measure: Type of Hospital Visits
timeFrame: Baseline up to approximately 7 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CEMIC
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Mar Del Plata
country: Argentina
facility: Hospital Privado De Comunidad; General Practice
city: North Sydney
country: Australia
facility: Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital; Medical Oncology and Pallative Care
state: New South Wales
city: South Brisbane
country: Australia
facility: Haematology & Oncology Clinics of Australia Research Centre
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre; Medical Oncology
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital; Oncology Research
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk, Apotheek
city: Rio de Janeiro
country: Brazil
facility: *X*Instituto Nacional do Cancer - INCA
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes; Centro de Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sao Jose
state: SP
city: Sofia
country: Bulgaria
facility: MHAT Serdika; Department of medical oncology
city: Sofia
country: Bulgaria
facility: SHATO - Sofia
city: Sofia
country: Bulgaria
facility: SHATOD - Sofia
city: Varna
country: Bulgaria
facility: District Oncology Dispensary Wit Stationary
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: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre; Oncology
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Center; Community Care Clinic / Oncology
state: Ontario
city: Toronto
country: Canada
facility: St. Michael'S Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve- Rosemont; Oncology
state: Quebec
city: Montreal
country: Canada
facility: Mcgill University - Royal Victoria Hospital; Oncology
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: Hillerod
country: Denmark
facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
city: København Ø
country: Denmark
facility: Rigshospitalet; Onkologisk Klinik
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Roskilde
country: Denmark
facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
city: Vejle
country: Denmark
facility: Vejle Sygehus; Onkologisk Afdeling
city: Santiago
country: Dominican Republic
facility: Hospital Metropolitano de Santiago
city: Guayaquil
country: Ecuador
facility: Clinica Alcivar, torre 1;Private office
city: Portoviejo
country: Ecuador
facility: Hospital Solca Portoviejo; Oncologia
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation; Oncology Center
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala
city: Kuopio
country: Finland
facility: KYS Sadesairaala; Syopatautien poliklinikka
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Oncology Clinics
city: Amiens
country: France
facility: Clinique De L Europe; Radiotherapie Chimiotherapie
city: Angers
country: France
facility: ICO Paul Papin; Oncologie Medicale.
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besançon
country: France
facility: Hopital Jean Minjoz - CHU de Besançon
city: Bordeaux
country: France
facility: Clinique Tivoli; Chimiotherapie Radiotherapie
city: Bordeaux
country: France
facility: Institut Bergonie; Oncologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Boulogne-billancourt
country: France
facility: Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie
city: Brest
country: France
facility: Hopital Morvan; Oncologie - Radiotherapie
city: Caen
country: France
facility: Centre Francois Baclesse; Radiotherapie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Oncologie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Grenoble
country: France
facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
city: Levallois Perret
country: France
facility: Centre Hartmann
city: Lille
country: France
facility: Centre Oscar Lambret; Senologie
city: Limoges
country: France
facility: Clinique Chenieux; Oncology
city: Lorient
country: France
facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes; Oncologie Medicale
city: Mont-de-marsan
country: France
facility: Hopital Layne; Medecine Ambulatoire
city: Montpellier
country: France
facility: Centre Val Aurelle Paul Lamarque; Recherche Clinique
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Perigueux
country: France
facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie
city: Perpignan
country: France
facility: Centre Catalan D' Oncologie
city: Plerin
country: France
facility: Clinique Armoricaine Radiologie; Hopital de Jour
city: Poitiers
country: France
facility: Pole Regional De Cancerologie
city: Reims CEDEX
country: France
facility: Institut Jean Godinot; Oncologie Medicale
city: Reims
country: France
facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie
city: Rennes
country: France
facility: Centre Eugene Marquis; Unite Huguenin
city: Rouen
country: France
facility: Centre Henri Becquerel; Oncologie Medicale
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: St Cloud
country: France
facility: Centre Rene Huguenin; CONSULT SPECIALISEES
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
city: Tours
country: France
facility: Centre Henry S Kaplan - CHU Bretonneau ; service oncologie
city: Vandoeuvre-les-nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Villejuif
country: France
facility: Institut Gustave Roussy; Pathologie Mammaire
city: Augsburg
country: Germany
facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter
city: Berlin
country: Germany
facility: Praxis Dres. Schilling & Till
city: Bottrop
country: Germany
facility: Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.
city: Dresden
country: Germany
facility: Onkozentrum Dres. Göhler
city: Erfurt
country: Germany
facility: Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Frauenklinik
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Hamburg
country: Germany
facility: HOPA MVZ GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
city: Koblenz
country: Germany
facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen; Med. Klinik III / Onkologie
city: Muenchen
country: Germany
facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
city: Porta Westfalica
country: Germany
facility: Praxis für Hämatologie und Onkologie
city: Rostock
country: Germany
facility: Universitaetsfrauenklinik; Und Poliklinik Am Klinikum
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen; Frauenklinik
city: Wiesbaden
country: Germany
facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
city: Würzburg
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
city: Crete
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: Uni Hospital of Ioannina; Oncology Dept.
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital; Medical Oncology
city: Guatemala
country: Guatemala
facility: Centro Oncológico Sixtino / Centro Oncológico SA
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital; Oncology
city: Shatin
country: Hong Kong
facility: Prince of Wales Hosp; Dept. Of Clinical Onc
city: Budapest
country: Hungary
facility: Ogyi, Orszagos Gyogyszereszeti Intezet
city: Budapest
country: Hungary
facility: Szent Imre Hospital; Dept. of Oncology
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
city: Kaposvar
country: Hungary
facility: Kaposi Mor County Hospital; Dept. of Oncology
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital, Department of Medical Oncology
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo General Hospital; Hematology & Oncology
city: Jakarta
country: Indonesia
facility: Dharmais National Cancer Center
city: Jakarta
country: Indonesia
facility: MRCCC Siloam Semanggi Hospital
city: Cork
country: Ireland
facility: Cork Uni Hospital; Oncology Dept
city: Dublin
country: Ireland
facility: St Vincent'S Uni Hospital; Medical Oncology
city: Dublin
country: Ireland
facility: Mater Misericordiae Uni Hospital; Oncology
city: Limerick
country: Ireland
facility: University Hospital Limerick - Oncology
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Napoli
country: Italy
facility: Università degli Studi Federico II; Clinica di Oncologia Medica
state: Campania
city: Bologna
country: Italy
facility: Ospedale Bellaria; U.O. Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: RCCS - Centro di Riferimento; Oncologia Medica B
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: Divisione Onc Med dell'Azienda
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
state: Lazio
city: Sora
country: Italy
facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Cremona
country: Italy
facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
state: Lombardia
city: Lecco
country: Italy
facility: ASST DI LECCO; Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele; Medical Oncology
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
state: Lombardia
city: Sesto San Giovanni (MI)
country: Italy
facility: Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
state: Piemonte
city: Novara
country: Italy
facility: Ospedale Maggiore Della Carita; Oncologia Medica
state: Piemonte
city: Torino
country: Italy
facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
state: Piemonte
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino; Oncologia Medica
state: Puglia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi; Div. Oncoematologia
state: Puglia
city: Catania
country: Italy
facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
state: Sicilia
city: Florence
country: Italy
facility: A.O.U Careggi
state: Toscana
city: Pontedera
country: Italy
facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
state: Toscana
city: Prato
country: Italy
facility: Ospedale Misericordia E Dolce; Oncologia Medica
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
state: Umbria
city: Camposampiero
country: Italy
facility: Ospedale Civile; Oncologia Medica
state: Veneto
city: Padova
country: Italy
facility: Ospedale Busonera; Oncologia Medica
state: Veneto
city: Verona
country: Italy
facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
state: Veneto
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon Medical School Gil Medical Center; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital; Oncology Haemotology
city: Luxembourg
country: Luxembourg
facility: CHL Hopital Municipal; Oncology
city: Mexico City
country: Mexico
facility: Hospital General de México
state: Mexico CITY (federal District)
city: D.f.
country: Mexico
facility: Medica Sur Centro Oncologico Integral
city: DF
country: Mexico
facility: Hospital Hmg Coyoacan
city: Mexico City
country: Mexico
facility: CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología
city: Mexico City
country: Mexico
facility: Inst. Nacional de Cancerologia; Investigacion Clinica
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
city: Amsterdam
country: Netherlands
facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Haag
country: Netherlands
facility: MC Haaglanden; Oncologie
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis; Interne Geneeskunde
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente, Hengelo
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis; Inwendige Geneeskunde
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden; Interne
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medisch Centrum; Inwendige Geneeskunde
city: Tilburg
country: Netherlands
facility: Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF; Ullevål sykehus
city: Panama
country: Panama
facility: Centro Hemato Oncologico Panama
city: Panama
country: Panama
facility: Centro Oncologico America
city: Lima
country: Peru
facility: Instituto;Oncologico Miraflores
city: Lima
country: Peru
facility: Clinica de Especialidades Medicas
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol
city: Kielce
country: Poland
facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
city: Rybnik
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Nr 3
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital da Luz; Departamento de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
city: Trencin
country: Slovakia
facility: Fakultna nemocnica Trencín; Onkologicke odd.
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Oncologia
state: Alicante
city: Elda
country: Spain
facility: Hospital General de Elda; Servicio de Oncologia
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Oncologia
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera; Servicio de Oncologia
state: Cadiz
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: San Sebastian
country: Spain
facility: Hospital de Donostia; Servicio de Oncologia Medica
state: Guipuzcoa
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
state: LAS Palmas
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
state: LAS Palmas
city: Leganes
country: Spain
facility: Hospital Severo Ochoa; Servicio de Oncologia
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Oncologia
state: Madrid
city: Vigo
country: Spain
facility: Hospital Xeral Cíes; Servicio de Oncologia
state: Pontevedra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
state: Tarragona
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Quiron Barcelona; Servicio de Oncologia
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara; Servicio de Oncologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
city: Lerida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Stockholm
country: Sweden
facility: Karolinska Hospital; Oncology - Radiumhemmet
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus; Onkologkliniken
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital; Surgery
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Centre; Hematology & Oncology
city: Taipei
country: Taiwan
facility: VETERANS GENERAL HOSPITAL; Department of General Surgery
city: Bangkok
country: Thailand
facility: Department of Surgery, King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
city: Ankara
country: Turkey
facility: Gazi Uni Medical Faculty Hospital; Oncology Dept
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty, Medical Oncology Department
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Istanbul
country: Turkey
facility: Istanbul Uni of Medicine Faculty; Oncology Dept
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
city: Istanbul
country: Turkey
facility: Marmara Uni Faculty of Medicine; Medical Oncology
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty Hospital; Oncology Dept
city: Izmir
country: Turkey
facility: Dokuz Eylul Uni ; Medical Oncology
city: Izmit
country: Turkey
facility: Kocaeli University Faculty of Medicine; Medical oncology
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham Queen Elizabeth Hospital
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Coventry
country: United Kingdom
facility: University Hospital coventry; Oncology Department
city: Eastbourne
country: United Kingdom
facility: Eastborne District General Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital; Clinical Oncology
city: Epping
country: United Kingdom
facility: St Margaret'S Hospital; Breast Unit
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital; Oncology Centre
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hosp.
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
city: Hull
country: United Kingdom
facility: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital; Oncology Pharmacy
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
city: London
country: United Kingdom
facility: Royal Free Hospital; Dept of Oncology
city: London
country: United Kingdom
facility: Guys & St Thomas Hospital; Department of Oncology
city: London
country: United Kingdom
facility: St George'S Hospital; Oncology Research Office /Oncology Opd
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: Maidstone
country: United Kingdom
facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Plymouth
country: United Kingdom
facility: Plymouth Oncology Centre; Clinical Trials Unit
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital, Portsmouth
city: Romford
country: United Kingdom
facility: Queen's Hospital; Oncology
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital; Cancer Clinical Trials Centre
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Pharmacy
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital; Macmillan Cancer Unit
city: York
country: United Kingdom
facility: York District Hospital
city: Barcelona
country: Venezuela
facility: Unidad de Mastologia y Atencion a la Mujer
city: Caracas
country: Venezuela
facility: Instituto Oncológico Luis Razetti
city: Caracas
country: Venezuela
facility: Instituto de Oncologia y Hematologia UCV
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.