Breast Cancer Clinical Trial

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Trial of Myocet in Metastatic Breast Cancer

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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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Metastatic Her2+ Breast cancer by FISH analysis
No prior chemotherapy for metastatic disease
Measurable disease
normal left ventricular ejection fraction

Exclusion Criteria:

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 is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

363

Study ID:

NCT00294996

Recruitment Status:

Unknown status

Sponsor:

Sopherion Therapeutics

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There are 28 Locations for this study

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Scripps Cancer Center Clinical Research
San Diego California, 92121, United States
University of Colorado
Aurora Colorado, 80045, United States
Northwest Hematology/Oncology Associates
Coral Springs Florida, 33065, United States
Osceola Cancer Center
Kissimmee Florida, 34741, United States
UM/Sylvester Cancer Center
Plantation Florida, 33324, United States
John B. Amos Cancer Center
Columbus Georgia, 31904, United States
Clintell, Inc
Skokie Illinois, 60076, United States
Hutchinson Clinic P.A.
Hutchinson Kansas, 67502, United States
Western Maryland Health System
Cumberland Maryland, 21502, United States
Brody School of Medicine @ ECU
Greenville North Carolina, 27834, United States
Aultman Hospital Cancer Center
Canton Ohio, 44710, United States
Hematology Oncology Consultants, Inc.
Columbus Ohio, 43235, United States
Vita Hematology Oncology
Bethlehem Pennsylvania, 18015, United States
Hematology & Oncology Associates of NEPA
Dunmore Pennsylvania, 18512, United States
PA Oncology Hematology Asso
Philadelphia Pennsylvania, 19106, United States
M. Francisco Gonzalez
Columbia South Carolina, 29203, United States
Sioux Valley Clinic
Sioux Falls South Dakota, 57104, United States
Tennessee Cancer Specialists
Knoxville Tennessee, 37920, 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, E1C 8, Canada
QEII Health Sciences Centre
Halifax Nova Scotia, B3H 1, Canada
London Regional Cancer Centre/London Health Science Centre
London Ontario, N6A 4, Canada
The Ottawa Hospital Regional Cancer Center
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
CHUM Hospital Notre-Dame
Montreal Quebec, H2L 4, Canada
McGill University
Montreal Quebec, H2W 1, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S47 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Hopital du St. Sacrement
Quebec , G1S 4, 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
Åšwidnica , , 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
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

363

Study ID:

NCT00294996

Recruitment Status:

Unknown status

Sponsor:


Sopherion Therapeutics

How clear is this clinincal trial information?

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