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ACTIVE NOT RECRUITING
NCT00781612
PHASE2

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

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

720

Start Date

2008-10-16

Completion Date

2030-04-30

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

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).

DRUG

Trastuzumab

Trastuzumab will be administered as per local prescribing information.

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).

DRUG

Atezolizumab

Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

Locations (178)

City of Hope National Medical Center

Duarte, California, United States

Can Care Assoc Med Group Inc

Redondo Beach, California, United States

Univ of Calif, San Francisco

San Francisco, California, United States

Central Coast Medical Oncology

San Luis Obispo, California, United States

UCLA Oncology Office

Santa Monica, California, United States

Stanford Cancer Institute

Stanford, California, United States

Kaiser Permanente - Walnut Creek

Walnut Creek, California, United States

Univ of Colorado Canc Ctr

Aurora, Colorado, United States

University of Colorado

Aurora, Colorado, United States

Rocky Mountain Cancer Center - Denver

Denver, Colorado, United States

Christina Care Institutional Review Board

Newark, Delaware, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Memorial Cancer Institute at Memorial West

Pembroke Pines, Florida, United States

Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)

St. Petersburg, Florida, United States

Florida Cancer Specialists - Tampa (Dr. MLK Blvd)

Tampa, Florida, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Kootenai Cancer Center

Post Falls, Idaho, United States

Loyola University Med Center

Maywood, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Hematology-Oncology

Bettendorf, Iowa, United States

Oncology Assoc of Cedar Rapids

Cedar Rapids, Iowa, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

Johns Hopkins Univ Med Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Minnesota Oncology Hematology, Pa

Minneapolis, Minnesota, United States

University of Minnesota.

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Mercy Clinic Cancer & Hematology

Springfield, Missouri, United States

St. John's Mercy Medical Ctr

St Louis, Missouri, United States

Comp Cancer Centers of Nevada

Las Vegas, Nevada, United States

St. Barnabas Health Care Sys

Livingston, New Jersey, United States

Clinical Research Alliance

Lake Success, New York, United States

NS-Long Island Jewish Hlth Sys

Lake Success, New York, United States

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, United States

Carolina Oncology Specialists, PA - Hickory

Hickory, North Carolina, United States

The Mark H. Zangmeister Ctr

Columbus, Ohio, United States

Northwest Cancer Specialists - Portland (N Broadway)

Portland, Oregon, United States

Sarah Cannon Research Institute / Tennessee Oncology

Chattanooga, Tennessee, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology

Bedford, Texas, United States

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

USO

Plano, Texas, United States

Cancer Therapy & Research Center

San Antonio, Texas, United States

USO - Tyler Cancer Ctr

Tyler, Texas, United States

Uni of Washington Medical Center

Seattle, Washington, United States

Univ of WA Medical Center

Seattle, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

UZ Gent

Ghent, Belgium

ZAS Sint Augustinus Wilrijk, Pharmacy

Wilrijk, Belgium

Clinica de Oncologia de Porto Alegre - CliniOnco

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, Brazil

Hospital Perola Byington

São Paulo, São Paulo, Brazil

Instituto Nacional de Cancer - INCa

Rio de Janeiro, Brazil

Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

Plovdiv, Bulgaria

SHATO - Sofia

Sofia, Bulgaria

BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY

Québec, Canada

Fundacion Arturo Lopez Perez

Santiago, Chile

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

Beijing, China

Beijing Cancer Hospital

Beijing, China

the First Hospital of Jilin University

Changchun, China

Sun Yet-sen University Cancer Center

Guangzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Jiangsu Cancer Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, China

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Poliklinika Vseobecne Fakultni Niemocnice

Prague, Czechia

Odense Universitetshospital, Onkologisk Afdeling R

Odense, Denmark

Vejle Sygehus

Vejle, Denmark

Centre Francois Baclesse

Caen, France

Centre Georges Francois Leclerc

Dijon, France

Institut Paoli Calmettes

Marseille, France

Institut régional du Cancer Montpellier

Montpellier, France

Hopital Tenon

Paris, France

Institut Curie

Paris, France

Institut Curie - Hopital Rene Huguenin

Saint-Cloud, France

Ico Rene Gauducheau

Saint-Herblain, France

Studienzentrum Aschaffenburg

Aschaffenburg, Germany

Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

Berlin, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Rotkreuzklinikum München

München, Germany

Klinikum der Universität München

München, Germany

Grupo Angeles

Guatemala City, Guatemala

Queen Mary Hospital

Hong Kong, Hong Kong

Szent Margit Hospital

Budapest, Hungary

Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

Debrecen, Hungary

Markusovszky Hospital

Szombathely, Hungary

Shaare Zedek Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Ctr

Tel Aviv, Israel

Ospedale San Carlo

Potenza, Basilicate, Italy

Campus Universitario S.Venuta

Catanzaro, Calabria, Italy

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

Naples, Campania, Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna, Italy

Ospedale Regionale Di Parma

Parma, Emilia-Romagna, Italy

RCCS - Centro di Riferimento

Aviano (PN), Friuli Venezia Giulia, Italy

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo

Candiolo, Piedmont, Italy

Ospedale Civile

Sassari, Sardinia, Italy

Humanitas Istituto Clinico Catanese S.p.A

Misterbianco (CT), Sicily, Italy

Hiroshima University Hospital

Hiroshima, Japan

Hyogo Cancer Center

Hyōgo, Japan

Centro de Investigacion

Acapulco de Juárez, Guerrero, Mexico

Instituto Nacional de Cancer

D.F., Mexico CITY (federal District), Mexico

Consultorio de Medicina Especializada

Distrito Federal, Mexico

Auckland city hospital

Auckland, New Zealand

Private Health Organization Acibadem Sistina Hospital

Skopje, North Macedonia

Oslo Universitetssykehus HF

Oslo, Norway

The Panama Clinic

Panama City, Panama

Instituto Nacional de Enfermedades Neoplasicas

Lima, Peru

Instituto

Lima, Peru

Cebu Cancer Institute

Cebu City, Philippines

Veterans Memorial Medical Ctr

Quezon City, Philippines

Cardinal Santos Medical Center

San Juan City, Philippines

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

?wi?tokrzyskie Centrum Onkologii

Kielce, Poland

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

Otwock, Poland

Wielkopolskie Centrum Onkologii

Poznan, Poland

Wojewódzki Szpital Specjalistyczny Nr 3

Rybnik, Poland

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warsaw, Poland

Hospital da Luz

Lisbon, Portugal

Centro Hospitalar do Porto ? Hospital de Santo António

Porto, Portugal

IPO do Porto

Porto, Portugal

Bashkirian Republican Clinical Oncology Dispensary

Ufa, Bashkortostan Republic, Russia

SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

Ufa, Bashkortostan Republic, Russia

City Clinical Oncology Hospital

Moscow, Moscow Oblast, Russia

Blokhin Cancer Research Center

Moskva, Moscow Oblast, Russia

FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF

Saint Petersburg, Sankt-Peterburg, Russia

City Oncology Dispensary

Saint Petersburg, Sankt-Peterburg, Russia

SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

Stavropol, Russia

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Kyungpook National University Medical Center

Daegu, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital de Jerez de la Frontera

Jerez de la Frontera, Cadiz, Spain

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital del Mar

Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Hospital Duran i Reynals

Barcelona, Spain

Hospital San Pedro De Alcantara

Cáceres, Spain

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Universitätsspital Zürich

Zurich, Switzerland

Chi-Mei Medical Center

Tainan, Taiwan

National Taiwan Uni Hospital

Taipei, Taiwan

Bumrungrad International Hosp

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Ninewells Hospital

Dundee, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Diana Princess of Wales Hosp.

Grimsby, United Kingdom

Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

Lancaster, United Kingdom

Royal Free Hospital

London, United Kingdom

Christie Hospital NHS Trust

Manchester, United Kingdom

Mount Vernon Hospital

Middlesex, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Poole General Hospital

Poole, United Kingdom

Queen's Hospital

Romford, United Kingdom

Abertawe and Bro Morgannwg NHS Trust

Swansea, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom