Breast Cancer Clinical Trial

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Summary

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension study
Participants in the control arm from Study BO21976/TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDM4529g (NCT00781612)
Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the participants and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period
Male participants whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period

Exclusion Criteria:

AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
Ongoing SAEs from the parent study
Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDM4688g (NCT00943670) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, 4.0 or 5.0, as utilized in the parent study
History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry
Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
Current severe, uncontrolled systemic disease (for example [e.g.] clinically significant cardiovascular, pulmonary, or metabolic disease)
Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
Current pregnancy or lactation
History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study
History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

720

Study ID:

NCT00781612

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 211 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
Can Care Assoc Med Group Inc; Beach Cities Offices
Los Angeles California, 90095, United States
Comp Cancer Centers of Nevada
Los Angeles California, 90095, United States
Univ of Calif, San Francisco; Breast Cancer Center
San Francisco California, 94115, United States
Central Coast Medical Oncology
Santa Maria California, 93454, United States
UCLA Oncology Office; Oncology
Santa Monica California, 90404, United States
Stanford Cancer Institute
Stanford California, 94305, United States
Kaiser Permanente; Oncology Clinical Trials
Vallejo California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek California, 94596, United States
Univ of Colorado Canc Ctr
Aurora Colorado, 80045, United States
University of Colorado
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Center - Denver
Littleton Colorado, 80120, United States
Christina Care Institutional Review Board
Newark Delaware, 18713, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers Florida, 33901, United States
Baptist - MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Univ of Miami Health Systems
Miami Florida, 33136, United States
Memorial Cancer Institute at Memorial West
Pembroke Pines Florida, 33028, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa Florida, 33607, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Kootenai Cancer Center
Post Falls Idaho, 83854, United States
Loyola University Med Center
Maywood Illinois, 60153, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
Midwestern Regional Medical Center; Office of Research
Zion Illinois, 60099, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Hematology-Oncology; Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Oncology Assoc of Cedar Rapids; Iowa Cancer Care
Cedar Rapids Iowa, 52403, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Anne Arundel Medical Center; Anne Arundel Health System
Annapolis Maryland, 21401, United States
Johns Hopkins Univ Med Center
Baltimore Maryland, 21231, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute; Breast Oncology
Boston Massachusetts, 02115, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Minnesota Oncology Hematology, Pa
Minneapolis Minnesota, 55407, United States
University of Minnesota.
Minneapolis Minnesota, 55454, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Capitol Comprehensive CA Care
Jefferson City Missouri, 65101, United States
St. John's Mercy Medical Ctr; David C. Pratt Cancer Center
Saint Louis Missouri, 63141, United States
Mercy Clinic Cancer & Hematology
Springfield Missouri, 65804, United States
St. Barnabas Health Care Sys
Livingston New Jersey, 07039, United States
NS-Long Island Jewish Hlth Sys
Lake Success New York, 11042, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Clinical Research Alliance
Westbury New York, 11590, United States
Carolina Oncology Specialists, PA - Hickory
Hickory North Carolina, 28602, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
Columbus Ohio, 43219, United States
Northwest Cancer Specialists - Portland (N Broadway)
Portland Oregon, 97227, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Sarah Cannon Cancer Center
Germantown Tennessee, 38138, United States
Vanderbilt Ingram Cancer Ctr
Nashville Tennessee, 37232, United States
Texas Oncology
Bedford Texas, 76022, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Millennium Research & Clinical Development
Houston Texas, 77090, United States
US Oncology Research Pharm.
Irving Texas, 75063, United States
US Oncology
Irving Texas, 75063, United States
USO
Plano Texas, 75075, United States
Cancer Therapy & Research Center
San Antonio Texas, 78229, United States
US Oncology Research, Inc.
The Woodlands Texas, 77380, United States
USO - Tyler Cancer Ctr
Tyler Texas, 75702, United States
Univ of WA Medical Center
Seattle Washington, 98109, United States
Uni of Washington Medical Center; Dept of Oncology
Seattle Washington, 98195, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
Peninsula and South Eastern Haematology and Oncology Group
Frankston Victoria, 3199, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
Klinik Favoriten; 1 Medizinische Abteilung
Wien , 1100, Austria
UZ Gent
Gent , 9000, Belgium
Sint Augustinus Wilrijk, Apotheek
Wilrijk , 2610, Belgium
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia BA, 40170, Brazil
Trymed Clinical Research
Belo Horizonte MG, 30150, Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro RJ, 20560, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre RS, 90050, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre RS, 90430, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Clinica de Neoplasias Litoral
Itajai SC, 88301, Brazil
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santo Andre SP, 09060, Brazil
Hospital Perola Byington
Sao Paulo SP, 01317, Brazil
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
Plovdiv , 4004, Bulgaria
SHATO - Sofia
Sofia , 1756, Bulgaria
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna British Columbia, V1Y 5, Canada
Ottawa Regional Cancer Centre; Civic Hospital Division
Ottawa Ontario, K1H 8, Canada
St. Michael'S Hospital
Toronto Ontario, M5B 1, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto Ontario, M5G 2, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal Quebec, H2X 0, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, SK S7, Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY
Quebec , G1S 4, Canada
Fundacion Arturo Lopez Perez
Santiago , 75009, Chile
Beijing Cancer Hospital
Beijing , 10014, China
the First Hospital of Jilin University
Changchun , 13002, China
Sun Yet-sen University Cancer Center
Guangzhou , 51006, China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou City , 31002, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing City , 21002, China
Jiangsu Cancer Hospital
Nanjing City , 21110, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Clinical Hospital Centre Zagreb
Zagreb , 10000, Croatia
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc , 779 0, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2 , 128 0, Czechia
Odense Universitetshospital, Onkologisk Afdeling R
Odense C , 5000, Denmark
Vejle Sygehus; Onkologisk Afdeling
Vejle , 7100, Denmark
Centre Francois Baclesse; Comite Sein
Caen , 14076, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon , 21079, France
Centre Hospitalier Departemental Les Oudairies
La Roche Sur Yon , 85925, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille , 13273, France
Institut régional du Cancer Montpellier
Montpellier , 34298, France
Hopital Tenon
Paris , 75020, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
Ico Rene Gauducheau; Oncologie
Saint Herblain , 44805, France
Studienzentrum Aschaffenburg
Aschaffenburg , 63739, Germany
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
Berlin , 13125, Germany
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin , 14169, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen , 45136, Germany
Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
Köln , 50931, Germany
Rotkreuzklinikum München; Frauenklinik
Muenchen , 80637, Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
Muenchen , 81377, Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund , 18439, Germany
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg , 97080, Germany
Grupo Angeles
Guatemala City , 01015, Guatemala
Queen Mary Hospital; Dept of Medicine
Hong Kong , , Hong Kong
Szent Margit Hospital; Dept. of Oncology
Budapest , 1032, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest , 1125, Hungary
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen , 4032, Hungary
Markusovszky Hospital
Szombathely , 9700, Hungary
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Kaplan Medical Center; Oncology Inst.
Rehovot , 76100, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv , 64239, Israel
Ospedale San Carlo; Day Hospital Oncologia Medica
Potenza Basilicata, 85100, Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro Calabria, 88100, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma Emilia-Romagna, 43100, Italy
RCCS - Centro di Riferimento; Oncologia Medica B
Aviano (PN) Friuli-Venezia Giulia, 33081, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine Friuli-Venezia Giulia, 33100, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano Lombardia, 20133, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo Piemonte, 10060, Italy
Ospedale Civile; Oncologia Medica
Sassari Sardegna, 07100, Italy
Humanitas Istituto Clinico Catanese S.p.A
Misterbianco (CT) Sicilia, 95045, Italy
A.O. Universitaria Pisana; Oncologia
Pisa Toscana, 56100, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato Toscana, 59100, Italy
Hiroshima University Hospital; Breast Surgery
Hiroshima , 734-8, Japan
Hyogo Cancer Center; Breast Surgery
Hyogo , 673-8, Japan
Saitama Medical University International Medical Center; Breast Oncology
Saitama , 350-1, Japan
Kyungpook National University Medical Center; Oncology
Daegu , 702-2, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Consultorio de Medicina Especializada
Mexico Mexico CITY (federal District), 03100, Mexico
Centro de Investigacion; Clinica Del Pacifico
Acapulco , 39670, Mexico
Instituto Nacional de Cancer
D.f. , 14080, Mexico
Oaxaca Site Management Organization
Oaxaca , 68000, Mexico
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland , 1023, New Zealand
Private Health Organization Acibadem Sistina Hospital
Skopje , 1000, North Macedonia
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo , 0310, Norway
Centro Hemato Oncologico Panama
Panama , 0832, Panama
Instituto;Oncologico Miraflores
Lima , 18, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima , Lima , Peru
Cebu Cancer Institute; Perpetual Succour Hospital
Cebu City , 6000, Philippines
Veterans Memorial Medical Ctr; Cancer Research Centre
Quezon City , 1101, Philippines
Cardinal Santos Medical Center
San Juan , 1502, Philippines
Uniwersyteckie Centrum Kliniczne
Gdansk , , Poland
Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
Kielce , 25-73, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin , 20-09, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock , 05-40, Poland
Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
Poznan , 61-86, Poland
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik , 44-20, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
Warszawa , 02-78, Poland
Hospital da Luz; Departamento de Oncologia Medica
Lisboa , 1500-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF
St Petersburg Leningrad, 19775, Russian Federation
Blokhin Cancer Research Center; Combined Treatment
Moskva Moskovskaja Oblast, 11547, Russian Federation
City Clinical Oncology Hospital
Moscow , 14342, Russian Federation
City Oncology Dispensary
St Petersburg , , Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol , 35504, Russian Federation
Bashkirian Republican Clinical Oncology Dispensary
UFA , 45005, Russian Federation
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
Institute of Oncology Ljubljana
Ljubljana , 1000, Slovenia
Hospital General Universitario de Elche; Servicio de Oncologia
Elche Alicante, 03203, Spain
Hospital de Jerez de la Frontera; Servicio de Oncologia
Jerez de La Frontera Cadiz, 11407, Spain
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian Guipuzcoa, 20080, Spain
Hospital Severo Ochoa; Servicio de Oncologia
Leganes Madrid, 28911, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Duran i Reynals; Oncologia
Barcelona , 08907, Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Caceres , 10003, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lerida , 25198, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain
Mälarsjukhuset; Onkologkliniken Sörmland
Eskilstuna , 63188, Sweden
Universitätsspital Zürich
Zürich , 8091, Switzerland
National Cheng Kung Uni Hospital; Surgery
Tainan , 704, Taiwan
Chi-Mei Medical Center
Tainan , 736, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei City , 11259, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei , 100, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan , 333, Taiwan
Bumrungrad International Hosp
Bangkok , 10110, Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok , 10400, Thailand
Ninewells Hospital
Dundee , DD12 , United Kingdom
Western General Hospital; Clinical Oncology
Edinburgh , EH4 2, United Kingdom
Diana Princess of Wales Hosp.
Grimsby , DN33 , United Kingdom
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
Lancaster , LA1 4, United Kingdom
Royal Free Hospital; Dept of Oncology
London , NW3 2, United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Mount Vernon Hospital
Middlesex , HA6 2, United Kingdom
Mount Vernon Cancer Centre
Northwood , HA6 2, United Kingdom
Nottingham City Hospital; Oncology
Nottingham , NG5 1, United Kingdom
Poole General Hospital
Poole , BH15 , United Kingdom
Queen's Hospital; Oncology
Romford , RM7 0, United Kingdom
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
Swansea , SA6 6, United Kingdom
Royal Cornwall Hospital
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

720

Study ID:

NCT00781612

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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