Trial of Myocet in Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00294996
- Lead Sponsor
- Sopherion Therapeutics
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 363
- Metastatic Her2+ Breast cancer by FISH analysis
- No prior chemotherapy for metastatic disease
- Measurable disease
- normal left ventricular ejection fraction
- prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
- relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression-Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival Safety
Trial Locations
- Locations (105)
Zakład Opieki Zdrowotnej MSWiA
🇵🇱Olsztyn, Poland
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Nizam's Institute of Medical Science
🇮🇳Hyderabaad, India
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, India
Apollo Specialty Hospitals, Chennai
🇮🇳Chennai, India
Indraprastha Apollo Hospitals
🇮🇳New Delhi, India
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Fortis Hospital
🇮🇳Noida, India
State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
🇷🇺Yaroslavl, Russian Federation
Orchid Nursing Home,
🇮🇳Kolkata, India
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Hutchinson Clinic P.A.
🇺🇸Hutchinson, Kansas, 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
Aultman Hospital Cancer Center
🇺🇸Canton, Ohio, United States
Hematology & Oncology Associates of NEPA
🇺🇸Dunmore, Pennsylvania, United States
PA Oncology Hematology Asso
🇺🇸Philadelphia, Pennsylvania, United States
Sioux Valley Clinic
🇺🇸Sioux Falls, South Dakota, United States
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
Centro Oncologico de Excelencia
🇦🇷Buenos Aires, Argentina
CAICI Instituto
🇦🇷Santa Fe, Argentina
Unidad Oncologica del Neuquen
🇦🇷Neuquen, Argentina
Centro Oncologico Rosario
🇦🇷Santa Fe, Argentina
London Regional Cancer Centre/London Health Science Centre
🇨🇦London, Ontario, Canada
Dr. Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
U.K Charité, Campus Mitte
🇩🇪Berlin, Germany
Himadri cancer welfare trusr
🇮🇳Kolkata, India
Gemeinschaftspraxis Gynäkologie & Geburtshilfe
🇩🇪Mannheim, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Frauenklinik von Roten Kreuz
🇩🇪München, Germany
Gujarat Cancer Research Institute
🇮🇳Asarwa, Gujarat, India
Üniversitäts Klinikum Tübingen
🇩🇪Tübingen, Germany
Manipal Hospital
🇮🇳Bangalore, India
Tata Memorial Hospital
🇮🇳Maharashtra, India
Batra Hospital & Medical Research Center
🇮🇳New Delhi, India
Oncologia Medica
🇮🇹Pavia, Italy
Kasturba Medical College,
🇮🇳Mangalore, India
ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
🇮🇹Palermo, Italy
Day Hospital Oncologico,
🇮🇹Roma, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
🇵🇱Gliwice, Poland
SP SK nr1 ACK AMG
🇵🇱Gdańsk, Poland
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
St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
🇷🇺St Petersberg, Russian Federation
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitari Arnau de Vilanova de Lleida
🇪🇸Lleida, Spain
Christie Hospital NHS Trust
🇬🇧Cardiff, United Kingdom
Broomfield Hospital
🇬🇧Broomfield, United Kingdom
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Mutua de Terrassa
🇪🇸Terrassa, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Scripps Cancer Center Clinical Research
🇺🇸San Diego, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Ceten
🇦🇷Villa Dominico, Argentina
Brody School of Medicine @ ECU
🇺🇸Greenville, North Carolina, United States
Northwest Hematology/Oncology Associates
🇺🇸Coral Springs, Florida, United States
Dr. Horst Schmidt Kliniken
🇩🇪Wiesbaden, Germany
Hematology Oncology Consultants, Inc.
🇺🇸Columbus, Ohio, United States
Klinikum Offenbach
🇩🇪Offenbach, Germany
Vita Hematology Oncology
🇺🇸Bethlehem, Pennsylvania, United States
Hospital Interzonal Gral de Agudos " EVITA"
🇦🇷Buenos Aires, Argentina
Western Maryland Health System
🇺🇸Cumberland, Maryland, United States
Hospital Enrique Tornú
🇦🇷Buenos Aires, Argentina
Hospital Profesor A. Posadas
🇦🇷Buenos Aires, Argentina
Santorio Municipal Dr. J. Mendez
🇦🇷Buenos Aires, Argentina
M. Francisco Gonzalez
🇺🇸Columbia, South Carolina, United States
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital Regional Cancer Center
🇨🇦Ottawa, Ontario, Canada
CHUM Hospital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Lakeshore Hospital and Research Centre Ltd
🇮🇳Kerala, India
McGill University
🇨🇦Montreal, Quebec, Canada
Hopital du St. Sacrement
🇨🇦Quebec, Canada
SMSMedicalCollegeHospital,
🇮🇳Jaipur, India
Jaslok Hospital and Research Centre
🇮🇳Mumbai, India
Azienda Ospedialera Pugliese-Ciaccio
🇮🇹Catanzaro, Italy
Safdarjung Hospital & Vardhaman Mahaveer Medical College
🇮🇳New Delhi, India
DIMI - Università di Genova
🇮🇹Genova, Italy
Clinica Oncologica Ospedale
🇮🇹Chieti, Italy
Samodzielny Publiczny Szpital
🇵🇱Lublin, Poland
nstituto Português de Oncologia Francisco Gentil
🇵🇹Lisbon, Portugal
Szpital Wojewódzki im. Św. Łukasza
🇵🇱Tarnow, Poland
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Regionalny Szpital Specjalistyczny
🇵🇱Świdnica, Poland
SP ZOZ Szpital Wojewódzki
🇵🇱Zielona Gora, Poland
Regionalny Ośrodek Onkologiczny
🇵🇱Łódź, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
🇵🇱Warszawa, Poland
State Health Care Institution "Leningrad Regional Oncology Dispensary"
🇷🇺St. Petersburg, Russian Federation
State Health Care Institution "Regional Clinical Oncology Dispensary"
🇷🇺Ryazan, 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
Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
🇷🇺Sochi, Russian Federation
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
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
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company
🇷🇺Moscow, Russian Federation
Royal Free Hospital
🇬🇧London, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Ruby Hall Clinic
🇮🇳Maharashtra, India