AzTrials
AzTrials

Breast CancerPhase 3NCT01702571

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 Phase 3 study testing Trastuzumab Emtansine in people with Breast Cancer, run by Hoffmann-La Roche at 300 sites in 43 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab Emtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,185 participants
Where
300 sitesin 43 countries
Study dates
27 Nov 2012to 31 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

300 sites in 43 countries.

300 sites in 43 countries

France40 sites

  • Clinique De L Europe; Radiotherapie Chimiotherapie

    Amiens, 80090

  • ICO Paul Papin; Oncologie Medicale.

    Angers, 49055

  • Institut Sainte Catherine

    Avignon, 84082

  • Hopital Jean Minjoz - CHU de Besançon

    Besançon, 25030

  • Clinique Tivoli; Chimiotherapie Radiotherapie

    Bordeaux, 33030

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077

  • Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie

    Boulogne-Billancourt, 92100

  • Hopital Morvan; Oncologie - Radiotherapie

    Brest, 29609

  • Centre Francois Baclesse; Radiotherapie

    Caen, 14076

  • Centre Jean Perrin; Oncologie

    Clermont-Ferrand, 63011

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

    Grenoble, 38043

  • Centre Hartmann

    Levallois-Perret, 92300

  • Centre Oscar Lambret; Senologie

    Lille, 59020

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Ch Bretagne Sud Site Scorff; Oncologie Medicale

    Lorient, 56100

  • Centre Leon Berard

    Lyon, 69008

  • Institut Paoli Calmettes; Oncologie Medicale

    Marseille, 13273

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-Marsan, 40024

  • Centre Val Aurelle Paul Lamarque; Recherche Clinique

    Montpellier, 34298

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Polyclinique Francheville; Med Chimiotherapie Radiotherapie

    Périgueux, 24000

  • Centre Catalan D' Oncologie

    Perpignan, 66000

  • Clinique Armoricaine Radiologie; Hopital de Jour

    Plérin, 22190

  • Pole Regional De Cancerologie

    Poitiers, 86021

  • Institut Jean Godinot; Oncologie Medicale

    Reims, 51056

  • Polyclinique De Courlancy; Centre Radiotherapie Oncologie

    Reims, 51057

  • Centre Eugene Marquis; Unite Huguenin

    Rennes, 35042

  • Centre Henri Becquerel; Oncologie Medicale

    Rouen, 76038

  • Centre Rene Huguenin; CONSULT SPECIALISEES

    Saint-Cloud, 92210

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

  • Centre Henry S Kaplan - CHU Bretonneau ; service oncologie

    Tours, 37044

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy; Pathologie Mammaire

    Villejuif, 94805

Other trials in France

Spain33 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

    A Coruña, 15006

  • Hospital General Univ. de Alicante; Servicio de Oncologia

    Alicante, 3010

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Quiron Barcelona; Servicio de Oncologia

    Barcelona, 08024

  • Hospital de Cruces; Servicio de Oncologia

    Bilbao, Vizcaya, 48903

  • Hospital San Pedro De Alcantara; Servicio de Oncologia

    Cáceres, 10003

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital de Donostia; Servicio de Oncologia Medica

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Hospital General Universitario de Elche; Servicio de Oncologia

    Elche, Alicante, 03203

  • Hospital General de Elda; Servicio de Oncologia

    Elda, Alicante, 03600

  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

    Girona, 17007

  • Hospital Universitario San Cecilio; Servicio de Oncologia

    Granada, 18003

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    Jaén, 23007

  • Hospital de Jerez de la Frontera; Servicio de Oncologia

    Jerez de la Frontera, Cadiz, 11407

  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

    Las Palmas de Gran Canaria, LAS Palmas, 35020

  • Hospital Severo Ochoa; Servicio de Oncologia

    Leganés, Madrid, 28911

  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

    Lleida, 25198

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Univ. Central de Asturias; Servicio de Oncologia

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Complejo Hospitalario de Pontevedra; Servicio de Oncologia

    Pontevedra, 36002

  • Hospital Quiron de Madrid; Servicio de Oncologia

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

    Reus, Tarragona, 43204

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 46014

  • Hospital Xeral Cíes; Servicio de Oncologia

    Vigo, Pontevedra, 36312

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Italy31 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Campania, 83100

  • RCCS - Centro di Riferimento; Oncologia Medica B

    Aviano (PN), Friuli Venezia Giulia, 33081

  • Ospedale Bellaria; U.O. Oncologia Medica

    Bologna, Emilia-Romagna, 40133

  • Ospedale Antonio Perrino; Oncologia Medica

    Brindisi, Apulia, 72100

  • Ospedale Civile; Oncologia Medica

    Camposampiero, Veneto, 35012

  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

    Candiolo, Piedmont, 10060

  • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

    Catania, Sicily, 95122

  • ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

    Cremona, Lombardy, 26100

  • A.O.U Careggi

    Florence, Tuscany, 50124

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

  • Ospedale Vito Fazzi; Div. Oncoematologia

    Lecce, Apulia, 73100

  • ASST DI LECCO; Oncologia Medica

    Lecco, Lombardy, 23900

  • Ospedale San Raffaele; Medical Oncology

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • A.O.U. Policlinico di Modena

    Modena, Emilia-Romagna, 40124

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Università degli Studi Federico II; Clinica di Oncologia Medica

    Naples, Campania, 80131

  • Ospedale Maggiore Della Carita; Oncologia Medica

    Novara, Piedmont, 28100

  • Ospedale Busonera; Oncologia Medica

    Padova, Veneto, 35128

  • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

    Pavia, Lombardy, 27100

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

    Perugia, Umbria, 06156

  • Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

    Piacenza, Emilia-Romagna, 29100

  • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

    Pontedera, Tuscany, 56025

  • Ospedale Misericordia E Dolce; Oncologia Medica

    Prato, Tuscany, 59100

  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

    Rome, Lazio, 00161

  • Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico

    Sesto San Giovanni (MI), Lombardy, 20099

  • Ospedale S.S. Trinità Nuovo; Divisione Oncologia

    Sora, Lazio, 03039

  • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

    Turin, Piedmont, 10126

  • Divisione Onc Med dell'Azienda

    Udine, Friuli Venezia Giulia, 33100

  • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

    Verona, Veneto, 37126

Other trials in Italy

United Kingdom29 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • University Hospital Birmingham Queen Elizabeth Hospital

    Birmingham, B17 0NH

  • Kent & Canterbury Hospital

    Canterbury, CT1 3NG

  • University Hospital coventry; Oncology Department

    Coventry, CV2 2DX

  • Eastborne District General Hospital

    Eastbourne, BN21 2UD

  • Western General Hospital; Clinical Oncology

    Edinburgh, EH4 2XU

  • St Margaret'S Hospital; Breast Unit

    Epping, CM16 6TN

  • Royal Devon & Exeter Hospital; Oncology Centre

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Diana Princess of Wales Hosp.

    Grimsby, DN33 2BA

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

    Hull, HU16 5JQ

  • Ipswich Hospital; Oncology Pharmacy

    Ipswich, IP4 5PD

  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

    Lancaster, LA1 4RP

  • Royal Free Hospital; Dept of Oncology

    London, NW3 2QG

  • Guys & St Thomas Hospital; Department of Oncology

    London, SE1 9RT

  • St George'S Hospital; Oncology Research Office /Oncology Opd

    London, SW17 ORE

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

    Maidstone, ME16 9QQ

  • Christie Hospital; Breast Cancer Research Office

    Manchester, M20 4QL

  • Mount Vernon Hospital

    Middlesex, HA6 2RN

  • Plymouth Oncology Centre; Clinical Trials Unit

    Plymouth, PL6 8DH

  • Queen Alexandra Hospital, Portsmouth

    Portsmouth, PO6 3LY

  • Queen's Hospital; Oncology

    Romford, RM7 0AG

  • Weston Park Hospital; Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

  • Singleton Hospital; Pharmacy

    Swansea, SA2 8QA

  • Yeovil District Hospital; Macmillan Cancer Unit

    Yeovil, BA21 4AT

  • York District Hospital

    York, YO31 8HE

Other trials in United Kingdom

Germany19 sites

  • Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

    Augsburg, 86150

  • Praxis Dres. Schilling & Till

    Berlin, 10317

  • Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.

    Bottrop, 46236

  • Onkozentrum Dres. Göhler

    Dresden, 01127

  • Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze

    Erfurt, 99085

  • Universitätsklinikum Erlangen; Frauenklinik

    Erlangen, 91054

  • OncoResearch Lerchenfeld GmbH

    Hamburg, 22081

  • HOPA MVZ GmbH

    Hamburg, 22767

  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

    Hanover, 30625

  • Institut für Versorgungsforschung in der Onkologie GbR Koblenz

    Koblenz, 56068

  • Klinikum Leverkusen; Med. Klinik III / Onkologie

    Leverkusen, 51375

  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

    München, 81377

  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

    Münster, 48149

  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

    Offenbach, 63069

  • Praxis für Hämatologie und Onkologie

    Porta Westfalica, 32457

  • Universitaetsfrauenklinik; Und Poliklinik Am Klinikum

    Rostock, 18059

  • Universitätsklinik Tübingen; Frauenklinik

    Tübingen, 72076

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

    Wiesbaden, 65199

  • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

    Würzburg, 97080

Other trials in Germany

Belgium10 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • GHdC Site Notre Dame

    Charleroi, 6000

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • Sint Augustinus Wilrijk, Apotheek

    Wilrijk, 2610

Other trials in Belgium

China10 sites

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • Chinese PLA General Hospital

    Beijing, 100853

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510000

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

Other trials in China

Turkey (Türkiye)10 sites

  • Gazi Uni Medical Faculty Hospital; Oncology Dept

    Ankara, 06500

  • Gaziantep University Medical Faculty, Medical Oncology Department

    Gaziantep, 27310

  • Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T

    Istanbul, 34093

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • Istanbul Uni of Medicine Faculty; Oncology Dept

    Istanbul, 34390

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

    Istanbul, 34865

  • Marmara Uni Faculty of Medicine; Medical Oncology

    Istanbul, 34890

  • Ege Uni Medical Faculty Hospital; Oncology Dept

    Izmir, 35100

  • Dokuz Eylul Uni ; Medical Oncology

    Izmir, 35340

  • Kocaeli University Faculty of Medicine; Medical oncology

    İzmit, 31380

Other trials in Turkey (Türkiye)

Canada9 sites

  • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

    Barrie, Ontario, L4M 6M2

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Hopital Maisonneuve- Rosemont; Oncology

    Montreal, Quebec, H1T 2M4

  • Mcgill University - Royal Victoria Hospital; Oncology

    Montreal, Quebec, H3A 1A1

  • Southlake Regional Health Center; Community Care Clinic / Oncology

    Newmarket, Ontario, L3Y 2P9

  • Dr. H. Bliss Murphy Cancer Centre; Oncology

    St. John's, Newfoundland and Labrador, A1B 3V6

  • BC Cancer - Surrey

    Surrey, British Columbia, V3V 1Z2

  • St. Michael'S Hospital

    Toronto, Ontario, M5B 1W8

  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Netherlands9 sites

  • Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

    Amsterdam, 1066 CX

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Deventer Ziekenhuis; Interne Geneeskunde

    Deventer, 7416 SE

  • Ziekenhuisgroep Twente, Hengelo

    Hengelo, 7555 DL

  • Spaarne Ziekenhuis; Inwendige Geneeskunde

    Hoofddorp, 2134 TM

  • Medisch Centrum Leeuwarden; Interne

    Leeuwarden, 8934 AD

  • Orbis Medisch Centrum; Inwendige Geneeskunde

    Sittard-Geleen, 6162 BG

  • MC Haaglanden; Oncologie

    The Hague, 2512 VA

  • Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde

    Tilburg, 5042 AD

Other trials in Netherlands

Australia8 sites

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Peter MacCallum Cancer Centre; Medical Oncology

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research

    North Sydney, New South Wales, 2059

  • Haematology & Oncology Clinics of Australia Research Centre

    South Brisbane, Queensland, 4101

  • Sunshine Hospital; Oncology Research

    St Albans, Victoria

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

  • Westmead Hospital; Medical Oncology and Pallative Care

    Westmead, New South Wales, 2145

Other trials in Australia

Denmark7 sites

  • Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

    Aalborg, 9000

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

  • Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

    Hillerød, 3400

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

  • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

    Roskilde, 4000

  • Vejle Sygehus; Onkologisk Afdeling

    Vejle, 7100

Other trials in Denmark

Mexico6 sites

  • Medica Sur Centro Oncologico Integral

    D.F., 14050

  • Hospital Hmg Coyoacan

    DF, 04110

  • Hospital General de México

    Mexico City, Mexico CITY (federal District), 06726

  • CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología

    Mexico City, 06725

  • Inst. Nacional de Cancerologia; Investigacion Clinica

    Mexico City, 14000

  • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

    Mexico City, Tlalpan 14000

Other trials in Mexico

Poland6 sites

  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

    Bialystok, 15-027

  • Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol

    Brzozów, 36-200

  • Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

    Kielce, 25-734

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400

  • Wojewódzki Szpital Specjalistyczny Nr 3

    Rybnik, 44-200

Other trials in Poland

Brazil5 sites

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • *X*Instituto Nacional do Cancer - INCA

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Hospital Sirio Libanes; Centro de Oncologia

    São Paulo, São Paulo, 01308-050

  • Hospital Sao Jose

    São Paulo, São Paulo, 01321-001

Other trials in Brazil

Hungary5 sites

  • Ogyi, Orszagos Gyogyszereszeti Intezet

    Budapest, 1051

  • Szent Imre Hospital; Dept. of Oncology

    Budapest, 1115

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

    Budapest, H-1077

  • Kaposi Mor County Hospital; Dept. of Oncology

    Kaposvár, 7400

Other trials in Hungary

South Korea5 sites

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Gachon Medical School Gil Medical Center; Medical Oncology

    Incheon, 405-760

  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

    Seoul, 03080

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

  • Korea University Anam Hospital; Oncology Haemotology

    Seoul, 136-705

Other trials in South Korea

Bulgaria4 sites

  • MHAT Serdika; Department of medical oncology

    Sofia, 1303

  • SHATO - Sofia

    Sofia, 1756

  • SHATOD - Sofia

    Sofia, 1784

  • District Oncology Dispensary Wit Stationary

    Varna, 9010

Other trials in Bulgaria

Finland4 sites

  • Helsingin yliopistollinen keskussairaala

    Helsinki, 00290

  • KYS Sadesairaala; Syopatautien poliklinikka

    Kuopio, 70210

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520

  • Turku Uni Central Hospital; Oncology Clinics

    Turku, 20520

Other trials in Finland

Greece4 sites

  • University General Hospital of Heraklion

    Crete, 711 10

  • Uni Hospital of Ioannina; Oncology Dept.

    Ioannina, 455 00

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Papageorgiou General Hospital; Medical Oncology

    Thessaloniki, 564 29

Other trials in Greece

Ireland4 sites

  • Cork Uni Hospital; Oncology Dept

    Cork

  • St Vincent'S Uni Hospital; Medical Oncology

    Dublin, 4

  • Mater Misericordiae Uni Hospital; Oncology

    Dublin, 7

  • University Hospital Limerick - Oncology

    Limerick

Other trials in Ireland

Argentina3 sites

  • CEMIC

    Buenos Aires, C1431FWO

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Hospital Privado De Comunidad; General Practice

    Mar del Plata, 7600

Other trials in Argentina

Austria3 sites

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

    Vienna, 1090

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

    Vienna, 1090

Other trials in Austria

Indonesia3 sites

  • Cipto Mangunkusumo General Hospital; Hematology & Oncology

    Jakarta, 10430

  • Dharmais National Cancer Center

    Jakarta, 11420

  • MRCCC Siloam Semanggi Hospital

    Jakarta, 12930

Other trials in Indonesia

Portugal3 sites

  • IPO de Lisboa; Servico de Oncologia Medica

    Lisbon, 1099-023

  • Hospital da Luz; Departamento de Oncologia Medica

    Lisbon, 1500-650

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Taiwan3 sites

  • National Cheng Kung Uni Hospital; Surgery

    Tainan, 704

  • Chi-Mei Medical Centre; Hematology & Oncology

    Tainan, 710

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

Other trials in Taiwan

Thailand3 sites

  • Department of Surgery, King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Pramongkutklao Hospital; Medicine - Medical Oncology Unit

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

    Chiang Mai, 50200

Other trials in Thailand

Venezuela3 sites

  • Unidad de Mastologia y Atencion a la Mujer

    Barcelona, 6001

  • Instituto Oncológico Luis Razetti

    Caracas, 1010

  • Instituto de Oncologia y Hematologia UCV

    Caracas, 1020

Other trials in Venezuela

Ecuador2 sites

  • Clinica Alcivar, torre 1;Private office

    Guayaquil, EC090114

  • Hospital Solca Portoviejo; Oncologia

    Portoviejo, EC130104

Other trials in Ecuador

Hong Kong2 sites

  • Princess Margaret Hospital; Oncology

    Hong Kong

  • Prince of Wales Hosp; Dept. Of Clinical Onc

    Shatin

Other trials in Hong Kong

Panama2 sites

  • Centro Hemato Oncologico Panama

    Panama City, 0832

  • Centro Oncologico America

    Panama City, 0834-02723

Other trials in Panama

Peru2 sites

  • Instituto;Oncologico Miraflores

    Lima, 18

  • Clinica de Especialidades Medicas

    Lima, Lima 41

Other trials in Peru

Slovakia2 sites

  • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

    Bratislava, 833 10

  • Fakultna nemocnica Trencín; Onkologicke odd.

    Trenčín, 911 71

Other trials in Slovakia

Sweden2 sites

  • Karolinska Hospital; Oncology - Radiumhemmet

    Stockholm, 171 76

  • Norrlands universitetssjukhus; Onkologkliniken

    Umeå

Other trials in Sweden

Croatia1 site

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Dominican Republic1 site

  • Hospital Metropolitano de Santiago

    Santiago de los Caballeros, 51000

Other trials in Dominican Republic

Estonia1 site

  • North Estonia Medical Centre Foundation; Oncology Center

    Tallinn, 13419

Other trials in Estonia

Guatemala1 site

  • Centro Oncológico Sixtino / Centro Oncológico SA

    Guatemala City, 01010

Other trials in Guatemala

Iceland1 site

  • Landspitali University Hospital, Department of Medical Oncology

    Reykjavik, 101

Other trials in Iceland

Luxembourg1 site

  • CHL Hopital Municipal; Oncology

    Luxembourg, 1210

Other trials in Luxembourg

Norway1 site

  • Oslo Universitetssykehus HF; Ullevål sykehus

    Oslo, 0450

Other trials in Norway

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

United Arab Emirates1 site

  • Tawam Hospital

    Al Ain City, 15258

Other trials in United Arab Emirates

About this study

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

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.

Conditions
Breast Cancer
Being tested
Trastuzumab Emtansine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab EmtansineDrug

    Also called RO5304020, T-DM1, Kadcyla

    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.

Study groups in NCT01702571
Study groupRoleWhat they receive
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.
Receives: Drug: Trastuzumab Emtansine
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.
Receives: Drug: Trastuzumab Emtansine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to approximately 7 years

Secondary outcomes (10)

  1. Percentage of Participants With Specific 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.

    Measured: Baseline up to approximately 7 years

  2. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were >3 × ULN, Concurrent elevation of total bilirubin >2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin >2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.

    Measured: Baseline up to approximately 7 years

  3. Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment

    Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

    Measured: 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)

  4. Overall Survival

    Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.

    Measured: Baseline until death (up to approximately 7 years)

  5. Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment

    Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.

    Measured: 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)

  6. Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1

    Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.

    Measured: 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)

  7. Duration of Response (DOR) According to RECIST v 1.1

    DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

    Measured: 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)

  8. Time to Response According to RECIST v 1.1

    Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.

    Measured: 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)

  9. Number of Hospital Visits

    The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.

    Measured: Baseline up to approximately 7 years

  10. Type of Hospital Visits

    The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.

    Measured: Baseline up to approximately 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2012 (estimated)
  2. Study start27 Nov 2012
  3. Primary completion31 Jul 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01702571
Sponsor's protocol ID
MO28231
Other IDs
2012-001628-37
Status last verified
Mar 2022
First submitted
4 Oct 2012
Last updated
4 Apr 2022
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36084395

  • 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.

    PubMed 34741021

  • 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.

    PubMed 32634611

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Emtansine in people with Breast Cancer, run by Hoffmann-La Roche at 300 sites in 43 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 300 sites in France, Spain, Italy, United Kingdom, Germany and 38 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events of Primary Interest (AEPIs) (time frame: Baseline up to approximately 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01702571, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.

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