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
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
2 other identifiers
interventional
2,185
40 countries
262
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Nov 2012
Typical duration for phase_3 breast-cancer
262 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2012
CompletedFirst Posted
Study publicly available on registry
October 8, 2012
CompletedStudy Start
First participant enrolled
November 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedResults Posted
Study results publicly available
August 5, 2021
CompletedApril 4, 2022
March 1, 2022
7.7 years
October 4, 2012
July 14, 2021
March 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Baseline up to approximately 7 years
Secondary Outcomes (10)
Percentage of Participants With Specific AEPIs
Baseline up to approximately 7 years
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Baseline up to approximately 7 years
Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
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)
Overall Survival
Baseline until death (up to approximately 7 years)
Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
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)
- +5 more secondary outcomes
Study Arms (2)
Trastuzumab Emtansine (All Participants)
EXPERIMENTALThis 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 (Asian Participants)
EXPERIMENTALThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (300)
CEMIC
Buenos Aires, C1431FWO, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Hospital Privado De Comunidad; General Practice
Mar del Plata, 7600, Argentina
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research
North Sydney, New South Wales, 2059, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Westmead Hospital; Medical Oncology and Pallative Care
Westmead, New South Wales, 2145, Australia
Haematology & Oncology Clinics of Australia Research Centre
South Brisbane, Queensland, 4101, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, 5037, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, 3000, Australia
Sunshine Hospital; Oncology Research
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, 1090, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, 1090, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Notre Dame
Charleroi, 6000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Sint Augustinus Wilrijk, Apotheek
Wilrijk, 2610, Belgium
*X*Instituto Nacional do Cancer - INCA
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034-000, Brazil
Hospital Sirio Libanes; Centro de Oncologia
São Paulo, São Paulo, 01308-050, Brazil
Hospital Sao Jose
São Paulo, São Paulo, 01321-001, Brazil
MHAT Serdika; Department of medical oncology
Sofia, 1303, Bulgaria
SHATO - Sofia
Sofia, 1756, Bulgaria
SHATOD - Sofia
Sofia, 1784, Bulgaria
District Oncology Dispensary Wit Stationary
Varna, 9010, Bulgaria
BC Cancer - Surrey
Surrey, British Columbia, V3V 1Z2, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Dr. H. Bliss Murphy Cancer Centre; Oncology
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie, Ontario, L4M 6M2, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Southlake Regional Health Center; Community Care Clinic / Oncology
Newmarket, Ontario, L3Y 2P9, Canada
St. Michael'S Hospital
Toronto, Ontario, M5B 1W8, Canada
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, H1T 2M4, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Beijing Cancer Hospital
Beijing, 100142, China
Chinese PLA General Hospital
Beijing, 100853, China
Sun Yat-sen Memorial Hospital
Guangzhou, 510000, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangsu Cancer Hospital
Nanjing, 211100, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, 9000, Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, 2730, Denmark
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerød, 3400, Denmark
Rigshospitalet; Onkologisk Klinik
København Ø, 2100, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, 5000, Denmark
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
Roskilde, 4000, Denmark
Vejle Sygehus; Onkologisk Afdeling
Vejle, 7100, Denmark
Hospital Metropolitano de Santiago
Santiago de los Caballeros, 51000, Dominican Republic
Clinica Alcivar, torre 1;Private office
Guayaquil, EC090114, Ecuador
Hospital Solca Portoviejo; Oncologia
Portoviejo, EC130104, Ecuador
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, 13419, Estonia
Helsingin yliopistollinen keskussairaala
Helsinki, 00290, Finland
KYS Sadesairaala; Syopatautien poliklinikka
Kuopio, 70210, Finland
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, 20520, Finland
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, 80090, France
ICO Paul Papin; Oncologie Medicale.
Angers, 49055, France
Institut Sainte Catherine
Avignon, 84082, France
Hopital Jean Minjoz - CHU de Besançon
Besançon, 25030, France
Clinique Tivoli; Chimiotherapie Radiotherapie
Bordeaux, 33030, France
Institut Bergonie; Oncologie
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077, France
Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie
Boulogne-Billancourt, 92100, France
Hopital Morvan; Oncologie - Radiotherapie
Brest, 29609, France
Centre Francois Baclesse; Radiotherapie
Caen, 14076, France
Centre Jean Perrin; Oncologie
Clermont-Ferrand, 63011, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, 38043, France
Centre Hartmann
Levallois-Perret, 92300, France
Centre Oscar Lambret; Senologie
Lille, 59020, France
Clinique Chenieux; Oncology
Limoges, 87039, France
Ch Bretagne Sud Site Scorff; Oncologie Medicale
Lorient, 56100, France
Centre Leon Berard
Lyon, 69008, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, 13273, France
Hopital Layne; Medecine Ambulatoire
Mont-de-Marsan, 40024, France
Centre Val Aurelle Paul Lamarque; Recherche Clinique
Montpellier, 34298, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Centre Catalan D' Oncologie
Perpignan, 66000, France
Polyclinique Francheville; Med Chimiotherapie Radiotherapie
Périgueux, 24000, France
Clinique Armoricaine Radiologie; Hopital de Jour
Plérin, 22190, France
Pole Regional De Cancerologie
Poitiers, 86021, France
Institut Jean Godinot; Oncologie Medicale
Reims, 51056, France
Polyclinique De Courlancy; Centre Radiotherapie Oncologie
Reims, 51057, France
Centre Eugene Marquis; Unite Huguenin
Rennes, 35042, France
Centre Henri Becquerel; Oncologie Medicale
Rouen, 76038, France
Centre Rene Huguenin; CONSULT SPECIALISEES
Saint-Cloud, 92210, France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076, France
Centre Henry S Kaplan - CHU Bretonneau ; service oncologie
Tours, 37044, France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy; Pathologie Mammaire
Villejuif, 94805, France
Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter
Augsburg, 86150, Germany
Praxis Dres. Schilling & Till
Berlin, 10317, Germany
Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.
Bottrop, 46236, Germany
Onkozentrum Dres. Göhler
Dresden, 01127, Germany
Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze
Erfurt, 99085, Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, 91054, Germany
OncoResearch Lerchenfeld GmbH
Hamburg, 22081, Germany
HOPA MVZ GmbH
Hamburg, 22767, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625, Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz
Koblenz, 56068, Germany
Klinikum Leverkusen; Med. Klinik III / Onkologie
Leverkusen, 51375, Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
München, 81377, Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, 48149, Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, 63069, Germany
Praxis für Hämatologie und Onkologie
Porta Westfalica, 32457, Germany
Universitaetsfrauenklinik; Und Poliklinik Am Klinikum
Rostock, 18059, Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, 72076, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
Wiesbaden, 65199, Germany
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg, 97080, Germany
University General Hospital of Heraklion
Crete, 711 10, Greece
Uni Hospital of Ioannina; Oncology Dept.
Ioannina, 455 00, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29, Greece
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, 01010, 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, 1051, Hungary
Szent Imre Hospital; Dept. of Oncology
Budapest, 1115, Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, H-1077, Hungary
Kaposi Mor County Hospital; Dept. of Oncology
Kaposvár, 7400, Hungary
Landspitali University Hospital, Department of Medical Oncology
Reykjavik, 101, Iceland
Cipto Mangunkusumo General Hospital; Hematology & Oncology
Jakarta, 10430, Indonesia
Dharmais National Cancer Center
Jakarta, 11420, Indonesia
MRCCC Siloam Semanggi Hospital
Jakarta, 12930, Indonesia
Cork Uni Hospital; Oncology Dept
Cork, Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin, 4, Ireland
Mater Misericordiae Uni Hospital; Oncology
Dublin, 7, Ireland
University Hospital Limerick - Oncology
Limerick, Ireland
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, 72100, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, 73100, Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, 83100, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli, Campania, 80131, Italy
Ospedale Bellaria; U.O. Oncologia Medica
Bologna, Emilia-Romagna, 40133, Italy
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, 40124, Italy
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
Piacenza, Emilia-Romagna, 29100, Italy
RCCS - Centro di Riferimento; Oncologia Medica B
Aviano (PN), Friuli Venezia Giulia, 33081, Italy
Divisione Onc Med dell'Azienda
Udine, Friuli Venezia Giulia, 33100, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Rome, Lazio, 00161, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora, Lazio, 03039, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona, Lombardy, 26100, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, 23900, Italy
Ospedale San Raffaele; Medical Oncology
Milan, Lombardy, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milan, Lombardy, 20133, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
Pavia, Lombardy, 27100, Italy
Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico
Sesto San Giovanni (MI), Lombardy, 20099, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piedmont, 10060, Italy
Ospedale Maggiore Della Carita; Oncologia Medica
Novara, Piedmont, 28100, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Turin, Piedmont, 10126, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicily, 95122, Italy
A.O.U Careggi
Florence, Tuscany, 50124, Italy
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
Pontedera, Tuscany, 56025, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, 59100, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, 06156, Italy
Ospedale Civile; Oncologia Medica
Camposampiero, Veneto, 35012, Italy
Ospedale Busonera; Oncologia Medica
Padua, Veneto, 35128, Italy
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona, Veneto, 37126, Italy
CHL Hopital Municipal; Oncology
Luxembourg, 1210, Luxembourg
Hospital General de México
Mexico City, Mexico CITY (federal District), 06726, Mexico
Medica Sur Centro Oncologico Integral
D.F., 14050, Mexico
Hospital Hmg Coyoacan
DF, 04110, Mexico
CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología
Mexico City, 06725, Mexico
Inst. Nacional de Cancerologia; Investigacion Clinica
Mexico City, 14000, Mexico
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Mexico City, Tlalpan 14000, Mexico
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
Amsterdam, 1066 CX, Netherlands
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
Deventer Ziekenhuis; Interne Geneeskunde
Deventer, 7416 SE, Netherlands
Ziekenhuisgroep Twente, Hengelo
Hengelo, 7555 DL, Netherlands
Spaarne Ziekenhuis; Inwendige Geneeskunde
Hoofddorp, 2134 TM, Netherlands
Medisch Centrum Leeuwarden; Interne
Leeuwarden, 8934 AD, Netherlands
Orbis Medisch Centrum; Inwendige Geneeskunde
Sittard-Geleen, 6162 BG, Netherlands
MC Haaglanden; Oncologie
The Hague, 2512 VA, Netherlands
Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde
Tilburg, 5042 AD, Netherlands
Oslo Universitetssykehus HF; Ullevål sykehus
Oslo, 0450, Norway
Centro Hemato Oncologico Panama
Panama City, 0832, Panama
Centro Oncologico America
Panama City, 0834-02723, Panama
Instituto;Oncologico Miraflores
Lima, 18, Peru
Clinica de Especialidades Medicas
Lima, Lima 41, Peru
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, 15-027, Poland
Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol
Brzozów, 36-200, Poland
Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
Kielce, 25-734, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 30-688, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, 05-400, Poland
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, 44-200, Poland
IPO de Lisboa; Servico de Oncologia Medica
Lisbon, 1099-023, Portugal
Hospital da Luz; Departamento de Oncologia Medica
Lisbon, 1500-650, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
Bratislava, 833 10, Slovakia
Fakultna nemocnica Trencín; Onkologicke odd.
Trenčín, 911 71, Slovakia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Kyungpook National University Medical Center
Daegu, 41404, South Korea
Gachon Medical School Gil Medical Center; Medical Oncology
Incheon, 405-760, South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752, South Korea
Korea University Anam Hospital; Oncology Haemotology
Seoul, 136-705, South Korea
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, 03203, Spain
Hospital General de Elda; Servicio de Oncologia
Elda, Alicante, 03600, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, 08916, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 8208, Spain
Hospital de Jerez de la Frontera; Servicio de Oncologia
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, 14004, Spain
Hospital de Donostia; Servicio de Oncologia Medica
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, 35020, Spain
Hospital Severo Ochoa; Servicio de Oncologia
Leganés, Madrid, 28911, Spain
Hospital Quiron de Madrid; Servicio de Oncologia
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Xeral Cíes; Servicio de Oncologia
Vigo, Pontevedra, 36312, Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, 43204, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, 48903, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, 15006, Spain
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante, 3010, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003, Spain
Hospital Quiron Barcelona; Servicio de Oncologia
Barcelona, 08024, Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, 10003, Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
Girona, 17007, Spain
Hospital Universitario San Cecilio; Servicio de Oncologia
Granada, 18003, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, 25198, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Complejo Hospitalario de Pontevedra; Servicio de Oncologia
Pontevedra, 36002, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, 46014, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm, 171 76, Sweden
Norrlands universitetssjukhus; Onkologkliniken
Umeå, Sweden
National Cheng Kung Uni Hospital; Surgery
Tainan, 704, Taiwan
Chi-Mei Medical Centre; Hematology & Oncology
Tainan, 710, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, 00112, Taiwan
Department of Surgery, King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, 50200, Thailand
Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, 06500, Turkey (Türkiye)
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, 27310, Turkey (Türkiye)
Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T
Istanbul, 34093, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
Istanbul Uni of Medicine Faculty; Oncology Dept
Istanbul, 34390, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
Istanbul, 34865, Turkey (Türkiye)
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, 34890, Turkey (Türkiye)
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul Uni ; Medical Oncology
Izmir, 35340, Turkey (Türkiye)
Kocaeli University Faculty of Medicine; Medical oncology
İzmit, 31380, Turkey (Türkiye)
Tawam Hospital
Al Ain City, 15258, United Arab Emirates
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
University Hospital Birmingham Queen Elizabeth Hospital
Birmingham, B17 0NH, United Kingdom
Kent & Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
University Hospital coventry; Oncology Department
Coventry, CV2 2DX, United Kingdom
Eastborne District General Hospital
Eastbourne, BN21 2UD, United Kingdom
Western General Hospital; Clinical Oncology
Edinburgh, EH4 2XU, United Kingdom
St Margaret'S Hospital; Breast Unit
Epping, CM16 6TN, United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, EX2 5DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Diana Princess of Wales Hosp.
Grimsby, DN33 2BA, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
Hull, HU16 5JQ, United Kingdom
Ipswich Hospital; Oncology Pharmacy
Ipswich, IP4 5PD, United Kingdom
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
Lancaster, LA1 4RP, United Kingdom
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
Guys & St Thomas Hospital; Department of Oncology
London, SE1 9RT, United Kingdom
St George'S Hospital; Oncology Research Office /Oncology Opd
London, SW17 ORE, United Kingdom
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone, ME16 9QQ, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
Mount Vernon Hospital
Middlesex, HA6 2RN, United Kingdom
Plymouth Oncology Centre; Clinical Trials Unit
Plymouth, PL6 8DH, United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth, PO6 3LY, United Kingdom
Queen's Hospital; Oncology
Romford, RM7 0AG, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, S10 2SJ, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ, United Kingdom
Singleton Hospital; Pharmacy
Swansea, SA2 8QA, United Kingdom
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, BA21 4AT, United Kingdom
York District Hospital
York, YO31 8HE, United Kingdom
Unidad de Mastologia y Atencion a la Mujer
Barcelona, 6001, Venezuela
Instituto Oncológico Luis Razetti
Caracas, 1010, Venezuela
Instituto de Oncologia y Hematologia UCV
Caracas, 1020, Venezuela
Related Publications (3)
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.
PMID: 36084395DERIVEDEngebraaten 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.
PMID: 34741021DERIVEDMontemurro 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.
PMID: 32634611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2012
First Posted
October 8, 2012
Study Start
November 27, 2012
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
April 4, 2022
Results First Posted
August 5, 2021
Record last verified: 2022-03