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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

This study is currently recruiting participants.
Verified November 2017 by Genentech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781612
First Posted: October 29, 2008
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents in a Genentech/Roche-sponsored parent study who are active and deriving benefit at the closure of parent study are eligible for continued treatment in this study.

Condition Intervention Phase
Neoplasm Metastasis Drug: Docetaxel Drug: Paclitaxel Drug: Pertuzumab Drug: Trastuzumab Drug: Trastuzumab Emtansine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years) ]
  • Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction [ Time Frame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years) ]

Estimated Enrollment: 720
Actual Study Start Date: October 16, 2008
Estimated Study Completion Date: September 21, 2022
Estimated Primary Completion Date: September 21, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab Emtansine
Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (pertuzumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.
Drug: Docetaxel
Docetaxel will be administered as per local prescribing information.
Drug: Paclitaxel
Paclitaxel will be administered as per local prescribing information.
Drug: Pertuzumab
Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
Other Name: Perjeta
Drug: Trastuzumab
Trastuzumab will be administered as per local prescribing information.
Other Name: Herceptin
Drug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
Other Name: Kadcyla; T-DM1

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 7 months after the last dose of study treatment
  • Male participants whose partners are pregnant should use condoms for the duration of the pregnancy

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 or 4.0, 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781612


Contacts
Contact: Reference Study ID Number: BO25430 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center Active, not recruiting
Duarte, California, United States, 91010
Can Care Assoc Med Group Inc; Beach Cities Offices Completed
Los Angeles, California, United States, 90095-1772
Comp Cancer Centers of Nevada Completed
Los Angeles, California, United States, 90095-1772
Univ of Calif, San Francisco; Breast Cancer Center Completed
San Francisco, California, United States, 94115
Central Coast Medical Oncology Completed
Santa Maria, California, United States, 93454
UCLA Oncology Office; Oncology Completed
Santa Monica, California, United States, 90404
Stanford Cancer Institute Completed
Stanford, California, United States, 94305-5456
Kaiser Permanente; Oncology Clinical Trials Active, not recruiting
Vallejo, California, United States, 94589
Kaiser Permanente - Walnut Creek Active, not recruiting
Walnut Creek, California, United States, 94596
United States, Colorado
University of Colorado Completed
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Center - Denver Completed
Denver, Colorado, United States, 80220
United States, Delaware
Christiana Care Health Srvcs Completed
Newark, Delaware, United States, 19713
United States, Florida
Florida Cancer Specialists; Department of Oncology Completed
Fort Myers, Florida, United States, 33901-8101
Baptist - MD Anderson Cancer Center Withdrawn
Jacksonville, Florida, United States, 32207
Univ of Miami Health Systems Withdrawn
Miami, Florida, United States, 33136
Memorial Cancer Institute at Memorial West Active, not recruiting
Pembroke Pines, Florida, United States, 33028
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) Completed
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists - Tampa (Dr. MLK Blvd) Completed
Tampa, Florida, United States, 33607
United States, Georgia
Northwest Georgia Oncology Centers PC - Marietta Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Idaho
Kootenai Cancer Center Completed
Post Falls, Idaho, United States, 83854
United States, Illinois
Loyola University Med Center Active, not recruiting
Maywood, Illinois, United States, 60153
Illinois Cancer Care Completed
Peoria, Illinois, United States, 61615
Midwestern Regional Medical Center; Office of Research Completed
Zion, Illinois, United States, 60099
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
Hematology-Oncology; Associates of the Quad Cities Completed
Bettendorf, Iowa, United States, 52722
Oncology Assoc of Cedar Rapids; Iowa Cancer Care Completed
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Cancer Center of Kansas Terminated
Wichita, Kansas, United States, 67214-3728
United States, Maine
New England Cancer Specialists Withdrawn
Scarborough, Maine, United States, 04074
United States, Maryland
Anne Arundel Medical Center Completed
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Massachusetts General Hospital Completed
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute; Breast Oncology Completed
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Institute Completed
Detroit, Michigan, United States, 48201
United States, Minnesota
Minnesota Oncology Hematology, Pa Completed
Minneapolis, Minnesota, United States, 55407
University of Minnesota. Completed
Minneapolis, Minnesota, United States, 55454
Mayo Clinic - Rochester Completed
Rochester, Minnesota, United States, 55905
United States, Missouri
Capitol Comprehensive CA Care Withdrawn
Jefferson City, Missouri, United States, 65101
St. John's Mercy Medical Ctr; David C. Pratt Cancer Center Completed
Saint Louis, Missouri, United States, 63141
Mercy Clinic Cancer & Hematology Completed
Springfield, Missouri, United States, 65804
United States, New Jersey
St. Barnabas Health Care Sys Completed
Livingston, New Jersey, United States, 07039
United States, New York
Clinical Research Alliance Completed
Lake Success, New York, United States, 11042
NS-Long Island Jewish Hlth Sys Completed
Lake Success, New York, United States, 11042
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States
United States, North Carolina
Carolina Oncology Specialists, PA - Hickory Completed
Hickory, North Carolina, United States, 28602
United States, Ohio
The Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. Completed
Columbus, Ohio, United States, 43219
United States, Oregon
Northwest Cancer Specialists - Portland (N Broadway) Completed
Portland, Oregon, United States, 97227
United States, Pennsylvania
Fox Chase Cancer Center Completed
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Cancer Center Completed
Germantown, Tennessee, United States, 38138
Vanderbilt Ingram Cancer Ctr Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology Completed
Bedford, Texas, United States, 76022
Texas Oncology - Dallas Presbyterian Hospital Completed
Dallas, Texas, United States, 75231
US Oncology Research Pharm. Terminated
Fort Worth, Texas, United States, 76177
US Oncology Completed
Fort Worth, Texas, United States, 76177
Millennium Oncology Withdrawn
Houston, Texas, United States, 77090
USO Active, not recruiting
Plano, Texas, United States, 75075-7787
Cancer Therapy & Research Center Completed
San Antonio, Texas, United States, 78229
US Oncology Research, Inc. Terminated
The Woodlands, Texas, United States, 77380
USO - Tyler Cancer Ctr Completed
Tyler, Texas, United States, 75702
United States, Washington
Univ of WA Medical Center Completed
Seattle, Washington, United States, 98109
Northwest Medical Specialties Completed
Tacoma, Washington, United States, 98405
Australia, Victoria
Peninsula Oncology Centre; Frankston Private Active, not recruiting
Frankston, Victoria, Australia, 3199
Austria
Kaiser Franz Josef Spital, 1. Medizinische Abteilung Withdrawn
Wien, Austria, 1100
Belgium
UZ Gent Active, not recruiting
Gent, Belgium, 9000
Sint Augustinus Wilrijk, Apotheek Active, not recruiting
Wilrijk, Belgium, 2610
Brazil
Clinica Amo - Assistencia Medica Em Oncologia Withdrawn
Salvador, BA, Brazil, 41950-610
Trymed Clinical Research Withdrawn
Belo Horizonte, MG, Brazil, 30150-281
Instituto Nacional de Cancer - INCa; Pesquisa Clinica Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Santa Casa de Misericordia de Porto Alegre Withdrawn
Porto Alegre, RS, Brazil, 90020-090
Clinica de Oncologia de Porto Alegre - CliniOnco Active, not recruiting
Porto Alegre, RS, Brazil, 90430-090
Hospital Sao Lucas - PUCRS Withdrawn
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao Completed
Porto Alegre, RS, Brazil, 91350-200
Clinica de Neoplasias Litoral Active, not recruiting
Itajai, SC, Brazil, 88301-220
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia Completed
Santo Andre, SP, Brazil, 09060-650
Hospital Perola Byington Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Bulgaria
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department Active, not recruiting
Plovdiv, Bulgaria, 4004
SHATO - Sofia Completed
Sofia, Bulgaria, 1756
Canada, British Columbia
Bcca - Cancer Center Southern Interior Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
Ottawa Regional Cancer Centre; Civic Hospital Division Active, not recruiting
Ottawa, Ontario, Canada, K1Y 4K7
St. Michael'S Hospital Terminated
Toronto, Ontario, Canada, M5B 1W8
University Health Network; Princess Margaret Hospital; Medical Oncology Dept Completed
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Chum - Hotel Dieu de Montreal Completed
Montreal, Quebec, Canada, H2X 0A9
Canada, Saskatchewan
Saskatoon Cancer Agency Active, not recruiting
Saskatoon, Saskatchewan, Canada, SK S7N 4H4
Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY Completed
Quebec, Canada, G1S 4L8
Chile
Fundacion Arturo Lopez Perez Active, not recruiting
Santiago, Chile, 7500921
Croatia
Clinical Hospital Centre Zagreb Withdrawn
Zagreb, Croatia, 10000
Czechia
Masarykuv onkologicky ustav Terminated
Brno, Czechia, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika Active, not recruiting
Olomouc, Czechia, 779 00
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika Completed
Praha 2, Czechia, 128 08
Denmark
Odense Universitetshospital, Onkologisk Afdeling R Active, not recruiting
Odense, Denmark, 5000
Vejle Sygehus Onkologisk Afd Active, not recruiting
Vejle, Denmark, 7100
France
Centre Francois Baclesse; Comite Sein Active, not recruiting
Caen, France, 14076
Centre Georges Francois Leclerc; Oncologie 3 Completed
Dijon, France, 21079
Centre Hospitalier Departemental Les Oudairies Withdrawn
La Roche Sur Yon, France, 85925
Institut Paoli Calmettes; Oncologie Medicale Recruiting
Marseille, France, 13273
Institut régional du Cancer Montpellier Active, not recruiting
Montpellier, France, 34298
Hopital Tenon Active, not recruiting
Paris, France, 75020
Institut Curie; Oncologie Medicale Completed
Paris, France, 75231
Ico Rene Gauducheau; Oncologie Completed
Saint Herblain, France, 44805
Germany
Studienzentrum Aschaffenburg Completed
Aschaffenburg, Germany, 63739
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe Completed
Berlin, Germany, 13125
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche Active, not recruiting
Berlin, Germany, 14169
Klinik und Poliklinik; Brustzentrum Terminated
Köln, Germany, 50931
Rotkreuzklinikum München; Frauenklinik Active, not recruiting
Muenchen, Germany, 80637
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde Active, not recruiting
Muenchen, Germany, 81377
gSUND Gynäkologie Kompetenzzentrum Stralsund; Frauenheilkunde & Geburtshilfe Completed
Stralsund, Germany, 18435
Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker Withdrawn
Würzburg, Germany, 97080
Guatemala
Grupo Angeles Active, not recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Queen Mary Hospital; Dept of Medicine Active, not recruiting
Hong Kong, Hong Kong
Hungary
Szent Margit Hospital; Dept. of Oncology Active, not recruiting
Budapest, Hungary, 1032
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika Withdrawn
Budapest, Hungary, 1125
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika Completed
Debrecen, Hungary, 4032
Markusovszky Hospital Completed
Szombathely, Hungary, 9700
Israel
Shaare Zedek Medical Center Completed
Jerusalem, Israel, 91031
Kaplan Medical Center; Oncology Inst. Withdrawn
Rehovot, Israel, 7610001
Tel Aviv Sourasky Medical Ctr; Oncology Completed
Tel Aviv, Israel, 6423906
Italy
Ospedale San Carlo; Day Hospital Oncologia Medica Completed
Potenza, Basilicata, Italy, 85100
Campus Universitario S.Venuta; Centro Oncologico T.Campanella Completed
Catanzaro, Calabria, Italy, 88100
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica Not yet recruiting
Napoli, Campania, Italy, 80131
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Completed
Meldola, Emilia-Romagna, Italy, 47014
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica Completed
Parma, Emilia-Romagna, Italy, 43100
RCCS - Centro di Riferimento; Oncologia Medica B Recruiting
Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia Completed
Udine, Friuli-Venezia Giulia, Italy, 33100
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Completed
Milano, Lombardia, Italy, 20133
Istituto Europeo Di Oncologia Recruiting
Milano, Lombardia, Italy, 20141
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico Recruiting
Candiolo, Piemonte, Italy, 10060
Ospedale Civile; Oncologia Medica Recruiting
Sassari, Sardegna, Italy, 07100
A.O. Universitaria Pisana; Oncologia Terminated
Pisa, Toscana, Italy, 56100
Ospedale Misericordia E Dolce; Oncologia Medica Withdrawn
Prato, Toscana, Italy, 59100
Japan
Hiroshima University Hospital; Breast Surgery Active, not recruiting
Hiroshima, Japan, 734-8551
Hyogo Cancer Center; Breast Surgery Active, not recruiting
Hyogo, Japan, 673-8558
Saitama Medical University International Medical Center; Breast Oncology Terminated
Saitama, Japan, 350-1298
Korea, Republic of
Kyungpook National University Medical Center; Oncology Active, not recruiting
Daegu, Korea, Republic of, 702-210
National Cancer Center Completed
Gyeonggi-do, Korea, Republic of, 10408
Gachon University Gil Medical Center Active, not recruiting
Incheon, Korea, Republic of, 21565
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05505
Asan Medical Center Completed
Seoul, Korea, Republic of, 05505
Samsung Medical Center Completed
Seoul, Korea, Republic of, 06351
Macedonia, The Former Yugoslav Republic of
Private Health Organization Acibadem Sistina Hospital Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Centro de Investigacion; Clinica Del Pacifico Completed
Acapulco, Mexico, 39670
Instituto Nacional de Cancer Completed
D.f., Mexico, 14080
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco Active, not recruiting
Mexico City, Mexico, 03100
Oaxaca Site Management Organization Withdrawn
Oaxaca, Mexico, 68000
New Zealand
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service Active, not recruiting
Auckland, New Zealand, 1023
Norway
Oslo Universitetssykehus HF; Radiumhospitalet Active, not recruiting
Oslo, Norway, 0310
Panama
Centro Hemato Oncologico Paitilla Active, not recruiting
Panama City, Panama, 083200752
Peru
Instituto;Oncologico Miraflores Active, not recruiting
Lima, Peru, 18
Philippines
Cebu Cancer Institute; Perpetual Succour Hospital Active, not recruiting
Cebu, Philippines, 6000
Veterans Memorial Medical Ctr; Cancer Research Centre Active, not recruiting
Quezon City, Philippines, 1101
Cardinal Santos Medical Center Active, not recruiting
San Juan, Philippines, 1502
Poland
Uniwersyteckie Centrum Kliniczne Active, not recruiting
Gdansk, Poland, 80-214
Świętokrzyskie Centrum Onkologii; Dział Chemioterapii Active, not recruiting
Kielce, Poland, 25-734
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej Withdrawn
Lublin, Poland, 20-090
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii Completed
Otwock, Poland, 05-400
Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii Active, not recruiting
Poznan, Poland, 61-866
Wojewódzki Szpital Specjalistyczny Nr 3 Active, not recruiting
Rybnik, Poland, 44-200
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii Active, not recruiting
Warszawa, Poland, 02-781
Portugal
Hospital da Luz; Departamento de Oncologia Medica Completed
Lisboa, Portugal, 1500-650
IPO do Porto; Servico de Oncologia Medica Active, not recruiting
Porto, Portugal, 4200-072
Russian Federation
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF Active, not recruiting
St Petersburg, Leningrad, Russian Federation, 197758
Blokhin Cancer Research Center; Combined Treatment Not yet recruiting
Moscow, Russian Federation, 115478
City Clinical Oncology Hospital Active, not recruiting
Moscow, Russian Federation, 143423
City Oncology Dispensary Recruiting
St Petersburg, Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary Completed
Stavropol, Russian Federation, 355045
Bashkirian Republican Clinical Oncology Dispensary Not yet recruiting
UFA, Russian Federation, 450054
Singapore
National University Hospital; National University Cancer Institute, Singapore (NCIS) Withdrawn
Singapore, Singapore, 119228
Slovenia
Institute of Oncology Ljubljana Active, not recruiting
Ljubljana, Slovenia, 1000
Spain
Hospital General Universitario de Elche; Servicio de Oncologia Active, not recruiting
Elche, Alicante, Spain, 03203
Hospital de Jerez de la Frontera; Servicio de Oncologia Active, not recruiting
Jerez de La Frontera, Cadiz, Spain, 11407
Hospital de Donostia; Servicio de Oncologia Medica Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Hospital Severo Ochoa; Servicio de Oncologia Withdrawn
Leganes, Madrid, Spain, 28911
Hospital del Mar; Servicio de Oncologia Active, not recruiting
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia Active, not recruiting
Barcelona, Spain, 08035
Hospital Duran i Reynals; Oncologia Completed
Barcelona, Spain, 08907
Hospital San Pedro De Alcantara; Servicio de Oncologia Active, not recruiting
Caceres, Spain, 10003
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia Active, not recruiting
Lerida, Spain, 25198
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Completed
Madrid, Spain, 28007
Hospital Universitario Clínico San Carlos; Servicio de Oncologia Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz; Servicio de Oncologia Not yet recruiting
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocio; Servicio de Oncologia Not yet recruiting
Sevilla, Spain, 41013
Hospital Universitario Miguel Servet; Servicio Oncologia Active, not recruiting
Zaragoza, Spain, 50009
Sweden
Mälarsjukhuset; Onkologkliniken Sörmland Completed
Eskilstuna, Sweden, 63188
Taiwan
National Cheng Kung Uni Hospital; Surgery Terminated
Tainan, Taiwan, 704
National Taiwan Uni Hospital; Dept of Oncology Completed
Taipei, Taiwan, 100
Chang Gung Memorial Hospital - Linkou Withdrawn
Taoyuan, Taiwan, 333
Thailand
Bumrungrad International Hosp Completed
Bangkok, Thailand, 10110
Rajavithi Hospital; Division of Medical Oncology Completed
Bangkok, Thailand, 10400
United Kingdom
Ninewells Hospital Completed
Dundee, United Kingdom, DD12 9SY
Western General Hospital; Clinical Oncology Completed
Edinburgh, United Kingdom, EH4 2XU
Diana Princess of Wales Hosp. Active, not recruiting
Grimsby, United Kingdom, DN33 2BA
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust Active, not recruiting
Lancaster, United Kingdom, LA1 4RP
Royal Free Hospital; Dept of Oncology Completed
London, United Kingdom, NW3 2QG
Christie Hospital NHS Trust Completed
Manchester, United Kingdom, M20 4BX
Mount Vernon Hospital Active, not recruiting
Middlesex, United Kingdom, HA6 2RN
Mount Vernon Cancer Centre Withdrawn
Northwood, United Kingdom, HA6 2RN
Nottingham City Hospital; Oncology Completed
Nottingham, United Kingdom, NG5 1PB
Poole General Hospital Completed
Poole, United Kingdom, BH15 2JB
Queen's Hospital; Oncology Active, not recruiting
Romford, United Kingdom, RM7 0AG
Royal Cornwall Hospital Completed
Truro, United Kingdom, TR1 3LQ
Sponsors and Collaborators
Genentech, Inc.
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00781612     History of Changes
Other Study ID Numbers: TDM4529g
BO25430 ( Other Identifier: Hoffmann-La Roche )
2010-021067-32 ( EudraCT Number )
First Submitted: October 27, 2008
First Posted: October 29, 2008
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Paclitaxel
Maytansine
Docetaxel
Ado-trastuzumab emtansine
Pertuzumab
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action