Clinical trial NCT00294996: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Metastatic Her2+ Breast cancer
Myocet
liposomal doxorubicin
trastuzumab
Lead sponsor: Sopherion Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 363
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-Free Survival
Secondary outcomes:
measure: Overall Survival
measure: Safety
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Cancer Center Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Coral Springs
country: United States
facility: Northwest Hematology/Oncology Associates
state: Florida
city: Kissimmee
country: United States
facility: Osceola Cancer Center
state: Florida
city: Plantation
country: United States
facility: UM/Sylvester Cancer Center
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Skokie
country: United States
facility: Clintell, Inc
state: Illinois
city: Hutchinson
country: United States
facility: Hutchinson Clinic P.A.
state: Kansas
city: Cumberland
country: United States
facility: Western Maryland Health System
state: Maryland
city: Greenville
country: United States
facility: Brody School of Medicine @ ECU
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Bethlehem
country: United States
facility: Vita Hematology Oncology
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of NEPA
state: Pennsylvania
city: Philadelphia
country: United States
facility: PA Oncology Hematology Asso
state: Pennsylvania
city: Columbia
country: United States
facility: M. Francisco Gonzalez
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Valley Clinic
state: South Dakota
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Centro Oncologico de Excelencia
city: Buenos Aires
country: Argentina
facility: Hospital Enrique Tornú
city: Buenos Aires
country: Argentina
facility: Hospital Interzonal Gral de Agudos " EVITA"
city: Buenos Aires
country: Argentina
facility: Hospital Profesor A. Posadas
city: Buenos Aires
country: Argentina
facility: Santorio Municipal Dr. J. Mendez
city: Neuquen
country: Argentina
facility: Unidad Oncologica del Neuquen
city: Santa Fe
country: Argentina
facility: CAICI Instituto
city: Santa Fe
country: Argentina
facility: Centro Oncologico Rosario
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Villa Dominico
country: Argentina
facility: Ceten
city: Moncton
country: Canada
facility: Dr. Leon Richard Oncology Centre
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Centre/London Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM Hospital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: Hopital du St. Sacrement
city: Berlin
country: Germany
facility: U.K Charité, Campus Mitte
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mannheim
country: Germany
facility: Gemeinschaftspraxis Gynäkologie & Geburtshilfe
city: München
country: Germany
facility: Frauenklinik von Roten Kreuz
city: Offenbach
country: Germany
facility: Klinikum Offenbach
city: Tübingen
country: Germany
facility: Üniversitäts Klinikum Tübingen
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Kliniken
city: Asarwa
country: India
facility: Gujarat Cancer Research Institute
state: Gujarat
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
city: Bangalore
country: India
facility: Manipal Hospital
city: Chennai
country: India
facility: Apollo Specialty Hospitals, Chennai
city: Hyderabaad
country: India
facility: Nizam's Institute of Medical Science
city: Jaipur
country: India
facility: SMSMedicalCollegeHospital,
city: Kerala
country: India
facility: Lakeshore Hospital and Research Centre Ltd
city: Kolkata
country: India
facility: Himadri cancer welfare trusr
city: Kolkata
country: India
facility: Orchid Nursing Home,
city: Maharashtra
country: India
facility: Ruby Hall Clinic
city: Maharashtra
country: India
facility: Tata Memorial Hospital
city: Mangalore
country: India
facility: Kasturba Medical College,
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
city: New Delhi
country: India
facility: Batra Hospital & Medical Research Center
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
city: New Delhi
country: India
facility: Safdarjung Hospital & Vardhaman Mahaveer Medical College
city: Noida
country: India
facility: Fortis Hospital
city: Catanzaro
country: Italy
facility: Azienda Ospedialera Pugliese-Ciaccio
city: Chieti
country: Italy
facility: Clinica Oncologica Ospedale
city: Genova
country: Italy
facility: DIMI - Università di Genova
city: Palermo
country: Italy
facility: ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
city: Pavia
country: Italy
facility: Oncologia Medica
city: Roma
country: Italy
facility: Day Hospital Oncologico,
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Gdańsk
country: Poland
facility: SP SK nr1 ACK AMG
city: Gliwice
country: Poland
facility: Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital
city: Olsztyn
country: Poland
facility: Zakład Opieki Zdrowotnej MSWiA
city: Tarnow
country: Poland
facility: Szpital Wojewódzki im. Św. Łukasza
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Zielona Gora
country: Poland
facility: SP ZOZ Szpital Wojewódzki
city: Łódź
country: Poland
facility: Regionalny Ośrodek Onkologiczny
city: Świdnica
country: Poland
facility: Regionalny Szpital Specjalistyczny
city: Lisbon
country: Portugal
facility: nstituto Português de Oncologia Francisco Gentil
city: Moscow
country: Russian Federation
facility: Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company
city: Moscow
country: Russian Federation
facility: State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development
city: Ryazan
country: Russian Federation
facility: State Health Care Institution "Regional Clinical Oncology Dispensary"
city: Sochi
country: Russian Federation
facility: Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
city: St Petersberg
country: Russian Federation
facility: St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
city: St Petersberg
country: Russian Federation
facility: State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development
city: St. Petersberg
country: Russian Federation
facility: 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
city: St. Petersburg
country: Russian Federation
facility: State Health Care Institution "Leningrad Regional Oncology Dispensary"
city: Yaroslavl
country: Russian Federation
facility: State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Broomfield
country: United Kingdom
facility: Broomfield Hospital
city: Cardiff
country: United Kingdom
facility: Christie Hospital NHS Trust
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Vall d'Hebron Hospital, Barcelona, Spain
name: Jose Baselga, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.