Trial of Myocet in Metastatic Breast Cancer
A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
1 other identifier
interventional
363
11 countries
105
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedMarch 31, 2009
March 1, 2009
February 17, 2006
March 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
Secondary Outcomes (2)
Overall Survival
Safety
Interventions
Eligibility Criteria
You may qualify if:
- Metastatic Her2+ Breast cancer by FISH analysis
- No prior chemotherapy for metastatic disease
- Measurable disease
- normal left ventricular ejection fraction
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (105)
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
Neuquén, Argentina
CAICI Instituto
Santa Fe, Argentina
Centro Oncologico Rosario
Santa Fe, Argentina
ISIS Clinica Especializada
Santa Fe, Argentina
Ceten
Villa Domínico, Argentina
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
London Regional Cancer Centre/London Health Science Centre
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Regional Cancer Center
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUM Hospital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S47 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Hopital du St. Sacrement
Québec, G1S 4L8, 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
Gdansk, Poland
Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
Gliwice, Poland
Regionalny Ośrodek Onkologiczny
Lodz, Poland
Samodzielny Publiczny Szpital
Lublin, Poland
Zakład Opieki Zdrowotnej MSWiA
Olsztyn, Poland
Regionalny Szpital Specjalistyczny
Swidnica, Poland
Szpital Wojewódzki im. Św. Łukasza
Tarnów, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw, Poland
Wojskowy Instytut Medyczny
Warsaw, Poland
SP ZOZ Szpital Wojewódzki
Zielona Góra, 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, Russia
State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences
Moscow, Russia
State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development
Moscow, Russia
State Health Care Institution "Regional Clinical Oncology Dispensary"
Ryazan, Russia
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
Saint Petersberg, Russia
St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
Saint Petersberg, Russia
State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development
Saint Petersberg, Russia
State Health Care Institution "Leningrad Regional Oncology Dispensary"
Saint Petersburg, Russia
Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
Sochi, Russia
State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
Yaroslavl, Russia
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
Seville, 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
Related Publications (1)
Baselga J, Manikhas A, Cortes J, Llombart A, Roman L, Semiglazov VF, Byakhov M, Lokanatha D, Forenza S, Goldfarb RH, Matera J, Azarnia N, Hudis CA, Rozencweig M. Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer. Ann Oncol. 2014 Mar;25(3):592-598. doi: 10.1093/annonc/mdt543. Epub 2014 Jan 8.
PMID: 24401928DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Baselga, M.D.
Vall d'Hebron Hospital, Barcelona, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 22, 2006
Study Start
January 1, 2006
Last Updated
March 31, 2009
Record last verified: 2009-03