Trial of Myocet in Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sopherion Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sopherion Therapeutics
ClinicalTrials.gov Identifier:
NCT00294996
First received: February 17, 2006
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Myocet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sopherion Therapeutics:

Primary Outcome Measures:
  • Progression-Free Survival

Secondary Outcome Measures:
  • Overall Survival
  • Safety

Enrollment: 363
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294996

  Hide Study Locations
Locations
United States, California
Scripps Cancer Center Clinical Research
San Diego, California, United States, 92121
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Northwest Hematology/Oncology Associates
Coral Springs, Florida, United States, 33065
Osceola Cancer Center
Kissimmee, Florida, United States, 34741
UM/Sylvester Cancer Center
Plantation, Florida, United States, 33324
United States, Georgia
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Illinois
Clintell, Inc
Skokie, Illinois, United States, 60076
United States, Kansas
Hutchinson Clinic P.A.
Hutchinson, Kansas, United States, 67502
United States, Maryland
Western Maryland Health System
Cumberland, Maryland, United States, 21502
United States, North Carolina
Brody School of Medicine @ ECU
Greenville, North Carolina, United States, 27834
United States, Ohio
Aultman Hospital Cancer Center
Canton, Ohio, United States, 44710
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
United States, Pennsylvania
Vita Hematology Oncology
Bethlehem, Pennsylvania, United States, 18015
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, United States, 18512
PA Oncology Hematology Asso
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
M. Francisco Gonzalez
Columbia, South Carolina, United States, 29203
United States, South Dakota
Sioux Valley Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37920
Argentina
Hospital Profesor A. Posadas
Buenos Aires, Argentina
Hospital Interzonal Gral de Agudos " EVITA"
Buenos Aires, Argentina
Centro Oncologico de Excelencia
Buenos Aires, Argentina
Hospital Enrique Tornú
Buenos Aires, Argentina
Santorio Municipal Dr. J. Mendez
Buenos Aires, Argentina
Unidad Oncologica del Neuquen
Neuquen, Argentina
ISIS Clinica Especializada
Santa Fe, Argentina
CAICI Instituto
Santa Fe, Argentina
Centro Oncologico Rosario
Santa Fe, Argentina
Ceten
Villa Dominico, Argentina
Canada, New Brunswick
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London Regional Cancer Centre/London Health Science Centre
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Regional Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM Hospital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S47 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Hopital du St. Sacrement
Quebec, Canada, G1S 4L8
Germany
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
India
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
Tata Memorial Hospital
Maharashtra, India
Ruby Hall Clinic
Maharashtra, India
Kasturba Medical College,
Mangalore, India
Jaslok Hospital and Research Centre
Mumbai, India
Indraprastha Apollo Hospitals
New Delhi, India
Batra Hospital & Medical Research Center
New Delhi, India
Safdarjung Hospital & Vardhaman Mahaveer Medical College
New Delhi, India
Fortis Hospital
Noida, India
Italy
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
Poland
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
Portugal
nstituto Português de Oncologia Francisco Gentil
Lisbon, Portugal
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
Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company
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
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
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 General Universitario de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
United Kingdom
Broomfield Hospital
Broomfield, United Kingdom
Christie Hospital NHS Trust
Cardiff, United Kingdom
Guy's Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Sponsors and Collaborators
Sopherion Therapeutics
Investigators
Principal Investigator: Jose Baselga, M.D. Vall d'Hebron Hospital, Barcelona, Spain
  More Information

No publications provided by Sopherion Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00294996     History of Changes
Other Study ID Numbers: STM01-102
Study First Received: February 17, 2006
Last Updated: March 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sopherion Therapeutics:
Metastatic Her2+ Breast cancer
Myocet
liposomal doxorubicin
trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014