search
Back to results

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

Primary Purpose

Neoplasm Metastasis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Docetaxel
Paclitaxel
Pertuzumab
Trastuzumab
Trastuzumab Emtansine
Atezolizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Medical Center
  • Can Care Assoc Med Group Inc; Beach Cities Offices
  • Comp Cancer Centers of Nevada
  • Univ of Calif, San Francisco; Breast Cancer Center
  • Central Coast Medical Oncology
  • UCLA Oncology Office; Oncology
  • Stanford Cancer Institute
  • Kaiser Permanente; Oncology Clinical Trials
  • Kaiser Permanente - Walnut Creek
  • Univ of Colorado Canc Ctr
  • University of Colorado
  • Rocky Mountain Cancer Center - Denver
  • Christina Care Institutional Review Board
  • Florida Cancer Specialists; Department of Oncology
  • Baptist - MD Anderson Cancer Center
  • Univ of Miami Health Systems
  • Memorial Cancer Institute at Memorial West
  • Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
  • Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
  • Northwest Georgia Oncology Centers PC - Marietta
  • Kootenai Cancer Center
  • Loyola University Med Center
  • Illinois Cancer Care
  • Midwestern Regional Medical Center; Office of Research
  • Indiana University Melvin and Bren Simon Cancer Center
  • Hematology-Oncology; Associates of the Quad Cities
  • Oncology Assoc of Cedar Rapids; Iowa Cancer Care
  • Cancer Center of Kansas
  • New England Cancer Specialists
  • Anne Arundel Medical Center; Anne Arundel Health System
  • Johns Hopkins Univ Med Center
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute; Breast Oncology
  • Karmanos Cancer Institute
  • Minnesota Oncology Hematology, Pa
  • University of Minnesota.
  • Mayo Clinic - Rochester
  • Capitol Comprehensive CA Care
  • St. John's Mercy Medical Ctr; David C. Pratt Cancer Center
  • Mercy Clinic Cancer & Hematology
  • St. Barnabas Health Care Sys
  • NS-Long Island Jewish Hlth Sys
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • Memorial Sloan-Kettering Cancer Center
  • Clinical Research Alliance
  • Carolina Oncology Specialists, PA - Hickory
  • The Cleveland Clinic Foundation
  • The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
  • Northwest Cancer Specialists - Portland (N Broadway)
  • Fox Chase Cancer Center
  • SCRI Tennessee Oncology Chattanooga
  • Sarah Cannon Cancer Center
  • Vanderbilt Ingram Cancer Ctr
  • Texas Oncology
  • Texas Oncology - Dallas Presbyterian Hospital
  • Millennium Research & Clinical Development
  • US Oncology Research Pharm.
  • US Oncology
  • USO
  • Cancer Therapy & Research Center
  • US Oncology Research, Inc.
  • USO - Tyler Cancer Ctr
  • Univ of WA Medical Center
  • Uni of Washington Medical Center; Dept of Oncology
  • Northwest Medical Specialties
  • Peninsula and South Eastern Haematology and Oncology Group
  • Peter MacCallum Cancer Center
  • Klinik Favoriten; 1 Medizinische Abteilung
  • UZ Gent
  • Sint Augustinus Wilrijk, Apotheek
  • Nucleo de Oncologia da Bahia - NOB
  • Trymed Clinical Research
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Santa Casa de Misericordia de Porto Alegre
  • Clinica de Oncologia de Porto Alegre - CliniOnco
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Clinica de Neoplasias Litoral
  • Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
  • Hospital Perola Byington
  • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
  • SHATO - Sofia
  • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
  • Ottawa Regional Cancer Centre; Civic Hospital Division
  • St. Michael'S Hospital
  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Centre Hospitalier de l?Université de Montréal (CHUM)
  • Saskatoon Cancer Centre
  • CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
  • Fundacion Arturo Lopez Perez
  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
  • Beijing Cancer Hospital
  • the First Hospital of Jilin University
  • Sun Yet-sen University Cancer Center
  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
  • Harbin Medical University Cancer Hospital
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer CenterRecruiting
  • Clinical Hospital Centre Zagreb
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Vejle Sygehus; Onkologisk Afdeling
  • Centre Francois Baclesse; Comite Sein
  • Centre Georges Francois Leclerc; Oncologie 3
  • Centre Hospitalier Departemental Les Oudairies
  • Institut Paoli Calmettes; Oncologie Medicale
  • Institut régional du Cancer Montpellier
  • Hopital Tenon
  • Institut Curie; Oncologie Medicale
  • Ico Rene Gauducheau; Oncologie
  • Studienzentrum Aschaffenburg
  • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
  • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
  • Rotkreuzklinikum München; Frauenklinik
  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
  • Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
  • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
  • Grupo Angeles
  • Queen Mary Hospital; Dept of Medicine
  • Szent Margit Hospital; Dept. of Oncology
  • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
  • Markusovszky Hospital
  • Shaare Zedek Medical Center
  • Kaplan Medical Center; Oncology Inst.
  • Tel Aviv Sourasky Medical Ctr; Oncology
  • Ospedale San Carlo; Day Hospital Oncologia Medica
  • Campus Universitario S.Venuta; Centro Oncologico T.Campanella
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
  • RCCS - Centro di Riferimento; Oncologia Medica B
  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  • Istituto Europeo Di Oncologia
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Ospedale Civile; Oncologia Medica
  • Humanitas Istituto Clinico Catanese S.p.A
  • A.O. Universitaria Pisana; Oncologia
  • Ospedale Misericordia E Dolce; Oncologia Medica
  • Hiroshima University Hospital; Breast Surgery
  • Hyogo Cancer Center; Breast Surgery
  • Saitama Medical University International Medical Center; Breast Oncology
  • Kyungpook National University Medical Center; Oncology
  • National Cancer Center
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Asan Medical Center
  • Samsung Medical Center
  • Centro de Investigacion; Clinica Del Pacifico
  • Instituto Nacional de Cancer
  • Consultorio de Medicina Especializada
  • Oaxaca Site Management Organization
  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
  • Private Health Organization Acibadem Sistina Hospital
  • Oslo Universitetssykehus HF; Radiumhospitalet
  • The Panama Clinic
  • Instituto;Oncologico Miraflores
  • Instituto Nacional de Enfermedades Neoplasicas
  • Cebu Cancer Institute; Perpetual Succour Hospital
  • Veterans Memorial Medical Ctr; Cancer Research Centre
  • Cardinal Santos Medical Center
  • Uniwersyteckie Centrum Kliniczne
  • ?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
  • Wojewódzki Szpital Specjalistyczny Nr 3
  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
  • Hospital da Luz; Departamento de Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Bashkirian Republican Clinical Oncology Dispensary
  • City Clinical Oncology Hospital
  • Blokhin Cancer Research Center; Combined Treatment
  • FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
  • City Oncology Dispensary
  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • Institute of Oncology Ljubljana
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital de Jerez de la Frontera; Servicio de Oncologia
  • Hospital de Donostia; Servicio de Oncologia Medica
  • Hospital Severo Ochoa; Servicio de Oncologia
  • Hospital del Mar; Servicio de Oncologia
  • Hospital Duran i Reynals; Oncologia
  • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Mälarsjukhuset; Onkologkliniken Sörmland
  • Universitätsspital Zürich
  • National Cheng Kung Uni Hospital; Surgery
  • Chi-Mei Medical Center
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • National Taiwan Uni Hospital; Dept of Oncology
  • Chang Gung Memorial Hospital - Linkou
  • Bumrungrad International Hosp
  • Rajavithi Hospital; Division of Medical Oncology
  • Ninewells Hospital
  • Western General Hospital; Clinical Oncology
  • Diana Princess of Wales Hosp.
  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
  • Royal Free Hospital; Dept of Oncology
  • Christie Hospital NHS Trust
  • Mount Vernon Hospital
  • Mount Vernon Cancer Centre
  • Nottingham City Hospital; Oncology
  • Poole General Hospital
  • Queen's Hospital; Oncology
  • Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trastuzumab Emtansine

Arm Description

Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, 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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction

Secondary Outcome Measures

Full Information

First Posted
October 27, 2008
Last Updated
October 12, 2023
Sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00781612
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2008 (Actual)
Primary Completion Date
September 20, 2029 (Anticipated)
Study Completion Date
September 20, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab Emtansine
Arm Type
Experimental
Arm Description
Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, 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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel will be administered as per local prescribing information.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered as per local prescribing information.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
Trastuzumab will be administered as per local prescribing information.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Emtansine
Other Intervention Name(s)
Kadcyla; T-DM1
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)
Primary Outcome Measure Information:
Title
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)
Title
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO25430 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Completed
Facility Name
Can Care Assoc Med Group Inc; Beach Cities Offices
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Individual Site Status
Completed
Facility Name
Comp Cancer Centers of Nevada
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Individual Site Status
Completed
Facility Name
Univ of Calif, San Francisco; Breast Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Completed
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Individual Site Status
Completed
Facility Name
UCLA Oncology Office; Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Completed
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Completed
Facility Name
Kaiser Permanente; Oncology Clinical Trials
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Completed
Facility Name
Kaiser Permanente - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Individual Site Status
Completed
Facility Name
Univ of Colorado Canc Ctr
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Rocky Mountain Cancer Center - Denver
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Completed
Facility Name
Christina Care Institutional Review Board
City
Newark
State/Province
Delaware
ZIP/Postal Code
18713
Country
United States
Individual Site Status
Completed
Facility Name
Florida Cancer Specialists; Department of Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Individual Site Status
Completed
Facility Name
Baptist - MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Withdrawn
Facility Name
Univ of Miami Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Memorial Cancer Institute at Memorial West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Completed
Facility Name
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Completed
Facility Name
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Completed
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Individual Site Status
Completed
Facility Name
Loyola University Med Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Completed
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Completed
Facility Name
Midwestern Regional Medical Center; Office of Research
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Individual Site Status
Completed
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Completed
Facility Name
Hematology-Oncology; Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Individual Site Status
Completed
Facility Name
Oncology Assoc of Cedar Rapids; Iowa Cancer Care
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Completed
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
Individual Site Status
Withdrawn
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Withdrawn
Facility Name
Anne Arundel Medical Center; Anne Arundel Health System
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins Univ Med Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Completed
Facility Name
Dana Farber Cancer Institute; Breast Oncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Completed
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Completed
Facility Name
Minnesota Oncology Hematology, Pa
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Completed
Facility Name
University of Minnesota.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Completed
Facility Name
Capitol Comprehensive CA Care
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. John's Mercy Medical Ctr; David C. Pratt Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Completed
Facility Name
Mercy Clinic Cancer & Hematology
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Completed
Facility Name
St. Barnabas Health Care Sys
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Completed
Facility Name
NS-Long Island Jewish Hlth Sys
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Completed
Facility Name
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Completed
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Research Alliance
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Individual Site Status
Completed
Facility Name
Carolina Oncology Specialists, PA - Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Individual Site Status
Completed
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Completed
Facility Name
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Cancer Specialists - Portland (N Broadway)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Completed
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Completed
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Completed
Facility Name
Sarah Cannon Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt Ingram Cancer Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Individual Site Status
Completed
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Completed
Facility Name
Millennium Research & Clinical Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Withdrawn
Facility Name
US Oncology Research Pharm.
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Withdrawn
Facility Name
US Oncology
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Completed
Facility Name
USO
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Individual Site Status
Completed
Facility Name
Cancer Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Completed
Facility Name
US Oncology Research, Inc.
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Withdrawn
Facility Name
USO - Tyler Cancer Ctr
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Completed
Facility Name
Univ of WA Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Completed
Facility Name
Uni of Washington Medical Center; Dept of Oncology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Completed
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Terminated
Facility Name
Peter MacCallum Cancer Center
City
North Melbourne
State/Province
Victoria
ZIP/Postal Code
3051
Country
Australia
Individual Site Status
Completed
Facility Name
Klinik Favoriten; 1 Medizinische Abteilung
City
Wien
ZIP/Postal Code
1100
Country
Austria
Individual Site Status
Withdrawn
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Sint Augustinus Wilrijk, Apotheek
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Completed
Facility Name
Nucleo de Oncologia da Bahia - NOB
City
Salvador, Bahia
State/Province
BA
ZIP/Postal Code
40170-380
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Trymed Clinical Research
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-281
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Individual Site Status
Completed
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Clinica de Oncologia de Porto Alegre - CliniOnco
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Completed
Facility Name
Clinica de Neoplasias Litoral
City
Itajai
State/Province
SC
ZIP/Postal Code
88301-220
Country
Brazil
Individual Site Status
Completed
Facility Name
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Completed
Facility Name
SHATO - Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Completed
Facility Name
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Individual Site Status
Completed
Facility Name
Ottawa Regional Cancer Centre; Civic Hospital Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Completed
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Withdrawn
Facility Name
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Completed
Facility Name
Centre Hospitalier de l?Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C2
Country
Canada
Individual Site Status
Completed
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
SK S7N 4H4
Country
Canada
Individual Site Status
Completed
Facility Name
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Completed
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Completed
Facility Name
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Withdrawn
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Completed
Facility Name
Odense Universitetshospital, Onkologisk Afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Completed
Facility Name
Vejle Sygehus; Onkologisk Afdeling
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Completed
Facility Name
Centre Francois Baclesse; Comite Sein
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Completed
Facility Name
Centre Georges Francois Leclerc; Oncologie 3
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Completed
Facility Name
Centre Hospitalier Departemental Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Withdrawn
Facility Name
Institut Paoli Calmettes; Oncologie Medicale
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Completed
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Completed
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Completed
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Individual Site Status
Completed
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Completed
Facility Name
Studienzentrum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Individual Site Status
Completed
Facility Name
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Completed
Facility Name
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
City
Köln
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Rotkreuzklinikum München; Frauenklinik
City
Muenchen
ZIP/Postal Code
80637
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Completed
Facility Name
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
City
Stralsund
ZIP/Postal Code
18439
Country
Germany
Individual Site Status
Completed
Facility Name
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Grupo Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Queen Mary Hospital; Dept of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Completed
Facility Name
Szent Margit Hospital; Dept. of Oncology
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Individual Site Status
Completed
Facility Name
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Completed
Facility Name
Markusovszky Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Completed
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Completed
Facility Name
Kaplan Medical Center; Oncology Inst.
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Tel Aviv Sourasky Medical Ctr; Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Completed
Facility Name
Ospedale San Carlo; Day Hospital Oncologia Medica
City
Potenza
State/Province
Basilicata
ZIP/Postal Code
85100
Country
Italy
Individual Site Status
Completed
Facility Name
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Completed
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Completed
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Completed
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Completed
Facility Name
RCCS - Centro di Riferimento; Oncologia Medica B
City
Aviano (PN)
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Completed
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Completed
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Completed
Facility Name
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale Civile; Oncologia Medica
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Completed
Facility Name
Humanitas Istituto Clinico Catanese S.p.A
City
Misterbianco (CT)
State/Province
Sicilia
ZIP/Postal Code
95045
Country
Italy
Individual Site Status
Completed
Facility Name
A.O. Universitaria Pisana; Oncologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedale Misericordia E Dolce; Oncologia Medica
City
Prato
State/Province
Toscana
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Hiroshima University Hospital; Breast Surgery
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Completed
Facility Name
Hyogo Cancer Center; Breast Surgery
City
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Completed
Facility Name
Saitama Medical University International Medical Center; Breast Oncology
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Kyungpook National University Medical Center; Oncology
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Centro de Investigacion; Clinica Del Pacifico
City
Acapulco
State/Province
Guerrero
ZIP/Postal Code
39670
Country
Mexico
Individual Site Status
Completed
Facility Name
Instituto Nacional de Cancer
City
D.f.
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Completed
Facility Name
Consultorio de Medicina Especializada
City
Mexico
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Completed
Facility Name
Oaxaca Site Management Organization
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Completed
Facility Name
Private Health Organization Acibadem Sistina Hospital
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Individual Site Status
Completed
Facility Name
Oslo Universitetssykehus HF; Radiumhospitalet
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Individual Site Status
Completed
Facility Name
The Panama Clinic
City
Panama
ZIP/Postal Code
0832-02723
Country
Panama
Individual Site Status
Active, not recruiting
Facility Name
Instituto;Oncologico Miraflores
City
Lima
ZIP/Postal Code
18
Country
Peru
Individual Site Status
Completed
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Individual Site Status
Active, not recruiting
Facility Name
Cebu Cancer Institute; Perpetual Succour Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Completed
Facility Name
Veterans Memorial Medical Ctr; Cancer Research Centre
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Individual Site Status
Completed
Facility Name
Cardinal Santos Medical Center
City
San Juan
ZIP/Postal Code
1502
Country
Philippines
Individual Site Status
Completed
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Completed
Facility Name
Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Wojewódzki Szpital Specjalistyczny Nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Hospital da Luz; Departamento de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Completed
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Bashkirian Republican Clinical Oncology Dispensary
City
UFA
State/Province
Baskortostan
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Completed
Facility Name
City Clinical Oncology Hospital
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Blokhin Cancer Research Center; Combined Treatment
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Completed
Facility Name
City Oncology Dispensary
City
St Petersburg
State/Province
Sankt Petersburg
Country
Russian Federation
Individual Site Status
Completed
Facility Name
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
City
Stavropol
ZIP/Postal Code
355045
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Completed
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital de Jerez de la Frontera; Servicio de Oncologia
City
Jerez de La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital de Donostia; Servicio de Oncologia Medica
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Severo Ochoa; Servicio de Oncologia
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Duran i Reynals; Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital San Pedro De Alcantara; Servicio de Oncologia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Completed
Facility Name
Mälarsjukhuset; Onkologkliniken Sörmland
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Individual Site Status
Completed
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Completed
Facility Name
National Cheng Kung Uni Hospital; Surgery
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Chi-Mei Medical Center
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Individual Site Status
Completed
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Completed
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Bumrungrad International Hosp
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand
Individual Site Status
Completed
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Terminated
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD12 9SY
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Western General Hospital; Clinical Oncology
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Diana Princess of Wales Hosp.
City
Grimsby
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Royal Free Hospital; Dept of Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Mount Vernon Hospital
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Nottingham City Hospital; Oncology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Poole General Hospital
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Queen's Hospital; Oncology
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this 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

We'll reach out to this number within 24 hrs