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Brief Title: Trial of Myocet in Metastatic Breast Cancer
Official Title: A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
Study ID: NCT00294996
Brief Summary: The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Scripps Cancer Center Clinical Research, San Diego, California, United States
University of Colorado, Aurora, Colorado, United States
Northwest Hematology/Oncology Associates, Coral Springs, Florida, United States
Osceola Cancer Center, Kissimmee, Florida, United States
UM/Sylvester Cancer Center, Plantation, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Clintell, Inc, Skokie, Illinois, United States
Hutchinson Clinic P.A., Hutchinson, Kansas, United States
Western Maryland Health System, Cumberland, Maryland, United States
Brody School of Medicine @ ECU, Greenville, North Carolina, United States
Aultman Hospital Cancer Center, Canton, Ohio, United States
Hematology Oncology Consultants, Inc., Columbus, Ohio, United States
Vita Hematology Oncology, Bethlehem, Pennsylvania, United States
Hematology & Oncology Associates of NEPA, Dunmore, Pennsylvania, United States
PA Oncology Hematology Asso, Philadelphia, Pennsylvania, United States
M. Francisco Gonzalez, Columbia, South Carolina, United States
Sioux Valley Clinic, Sioux Falls, South Dakota, United States
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
Centro Oncologico de Excelencia, Buenos Aires, , Argentina
Hospital Enrique Tornú, Buenos Aires, , Argentina
Hospital Interzonal Gral de Agudos " EVITA", Buenos Aires, , Argentina
Hospital Profesor A. Posadas, Buenos Aires, , Argentina
Santorio Municipal Dr. J. Mendez, Buenos Aires, , Argentina
Unidad Oncologica del Neuquen, Neuquen, , Argentina
CAICI Instituto, Santa Fe, , Argentina
Centro Oncologico Rosario, Santa Fe, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
Ceten, Villa Dominico, , Argentina
Dr. Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
London Regional Cancer Centre/London Health Science Centre, London, Ontario, Canada
The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM Hospital Notre-Dame, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Hopital du St. Sacrement, Quebec, , Canada
U.K Charité, Campus Mitte, Berlin, , Germany
Universitätsklinikum Magdeburg, Magdeburg, , Germany
Gemeinschaftspraxis Gynäkologie & Geburtshilfe, Mannheim, , Germany
Frauenklinik von Roten Kreuz, München, , Germany
Klinikum Offenbach, Offenbach, , Germany
Üniversitäts Klinikum Tübingen, Tübingen, , Germany
Dr. Horst Schmidt Kliniken, Wiesbaden, , Germany
Gujarat Cancer Research Institute, Asarwa, Gujarat, India
Kidwai Memorial Institute of Oncology, Bangalore, , India
Manipal Hospital, Bangalore, , India
Apollo Specialty Hospitals, Chennai, Chennai, , India
Nizam's Institute of Medical Science, Hyderabaad, , India
SMSMedicalCollegeHospital,, Jaipur, , India
Lakeshore Hospital and Research Centre Ltd, Kerala, , India
Himadri cancer welfare trusr, Kolkata, , India
Orchid Nursing Home,, Kolkata, , India
Ruby Hall Clinic, Maharashtra, , India
Tata Memorial Hospital, Maharashtra, , India
Kasturba Medical College,, Mangalore, , India
Jaslok Hospital and Research Centre, Mumbai, , India
Batra Hospital & Medical Research Center, New Delhi, , India
Indraprastha Apollo Hospitals, New Delhi, , India
Safdarjung Hospital & Vardhaman Mahaveer Medical College, New Delhi, , India
Fortis Hospital, Noida, , India
Azienda Ospedialera Pugliese-Ciaccio, Catanzaro, , Italy
Clinica Oncologica Ospedale, Chieti, , Italy
DIMI - Università di Genova, Genova, , Italy
ARNAS CIVICO. Presidio Ospedaliero M. Ascoli, Palermo, , Italy
Oncologia Medica, Pavia, , Italy
Day Hospital Oncologico,, Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
SP SK nr1 ACK AMG, Gdańsk, , Poland
Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice, Gliwice, , Poland
Samodzielny Publiczny Szpital, Lublin, , Poland
Zakład Opieki Zdrowotnej MSWiA, Olsztyn, , Poland
Szpital Wojewódzki im. Św. Łukasza, Tarnow, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Warszawa, , Poland
Wojskowy Instytut Medyczny, Warszawa, , Poland
SP ZOZ Szpital Wojewódzki, Zielona Gora, , Poland
Regionalny Ośrodek Onkologiczny, Łódź, , Poland
Regionalny Szpital Specjalistyczny, Świdnica, , Poland
nstituto Português de Oncologia Francisco Gentil, Lisbon, , Portugal
Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company, Moscow, , Russian Federation
State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences, Moscow, , Russian Federation
State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development, Moscow, , Russian Federation
State Health Care Institution "Regional Clinical Oncology Dispensary", Ryazan, , Russian Federation
Municipal Health Care Institution of the City of Sochi "Oncology Dispensary", Sochi, , Russian Federation
St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary", St Petersberg, , Russian Federation
State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development, St Petersberg, , Russian Federation
Research Institute of Pulmonology affiliated with State Educational Institution "St. Petersburg State Medical University n.a. academician I.P. Pavlov" of the Federal Agency of Health Care and Social Development, St. Petersberg, , Russian Federation
State Health Care Institution "Leningrad Regional Oncology Dispensary", St. Petersburg, , Russian Federation
State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary", Yaroslavl, , Russian Federation
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitari Arnau de Vilanova de Lleida, Lleida, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Son Dureta, Palma de Mallorca, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Virgen Macarena, Sevilla, , Spain
Hospital Mutua de Terrassa, Terrassa, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Broomfield Hospital, Broomfield, , United Kingdom
Christie Hospital NHS Trust, Cardiff, , United Kingdom
Guy's Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Name: Jose Baselga, M.D.
Affiliation: Vall d'Hebron Hospital, Barcelona, Spain
Role: PRINCIPAL_INVESTIGATOR