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Trial of Myocet in Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Myocet
Sponsored by
Sopherion Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic Her2+ Breast cancer, Myocet, liposomal doxorubicin, trastuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Cancer Center Clinical Research
  • University of Colorado
  • Northwest Hematology/Oncology Associates
  • Osceola Cancer Center
  • UM/Sylvester Cancer Center
  • John B. Amos Cancer Center
  • Clintell, Inc
  • Hutchinson Clinic P.A.
  • Western Maryland Health System
  • Brody School of Medicine @ ECU
  • Aultman Hospital Cancer Center
  • Hematology Oncology Consultants, Inc.
  • Vita Hematology Oncology
  • Hematology & Oncology Associates of NEPA
  • PA Oncology Hematology Asso
  • M. Francisco Gonzalez
  • Sioux Valley Clinic
  • Tennessee Cancer Specialists
  • Centro Oncologico de Excelencia
  • Hospital Enrique Tornú
  • Hospital Interzonal Gral de Agudos " EVITA"
  • Hospital Profesor A. Posadas
  • Santorio Municipal Dr. J. Mendez
  • Unidad Oncologica del Neuquen
  • CAICI Instituto
  • Centro Oncologico Rosario
  • ISIS Clinica Especializada
  • Ceten
  • Dr. Leon Richard Oncology Centre
  • QEII Health Sciences Centre
  • London Regional Cancer Centre/London Health Science Centre
  • The Ottawa Hospital Regional Cancer Center
  • Princess Margaret Hospital
  • CHUM Hospital Notre-Dame
  • McGill University
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Hopital du St. Sacrement
  • U.K Charité, Campus Mitte
  • Universitätsklinikum Magdeburg
  • Gemeinschaftspraxis Gynäkologie & Geburtshilfe
  • Frauenklinik von Roten Kreuz
  • Klinikum Offenbach
  • Üniversitäts Klinikum Tübingen
  • Dr. Horst Schmidt Kliniken
  • Gujarat Cancer Research Institute
  • Kidwai Memorial Institute of Oncology
  • Manipal Hospital
  • Apollo Specialty Hospitals, Chennai
  • Nizam's Institute of Medical Science
  • SMSMedicalCollegeHospital,
  • Lakeshore Hospital and Research Centre Ltd
  • Himadri cancer welfare trusr
  • Orchid Nursing Home,
  • Ruby Hall Clinic
  • Tata Memorial Hospital
  • Kasturba Medical College,
  • Jaslok Hospital and Research Centre
  • Batra Hospital & Medical Research Center
  • Indraprastha Apollo Hospitals
  • Safdarjung Hospital & Vardhaman Mahaveer Medical College
  • Fortis Hospital
  • Azienda Ospedialera Pugliese-Ciaccio
  • Clinica Oncologica Ospedale
  • DIMI - Università di Genova
  • ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
  • Oncologia Medica
  • Day Hospital Oncologico,
  • Istituto Clinico Humanitas
  • SP SK nr1 ACK AMG
  • Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
  • Samodzielny Publiczny Szpital
  • Zakład Opieki Zdrowotnej MSWiA
  • Szpital Wojewódzki im. Św. Łukasza
  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
  • Wojskowy Instytut Medyczny
  • SP ZOZ Szpital Wojewódzki
  • Regionalny Ośrodek Onkologiczny
  • Regionalny Szpital Specjalistyczny
  • nstituto Português de Oncologia Francisco Gentil
  • Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company
  • State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences
  • State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development
  • State Health Care Institution "Regional Clinical Oncology Dispensary"
  • Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
  • St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
  • State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development
  • 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
  • State Health Care Institution "Leningrad Regional Oncology Dispensary"
  • State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitari Arnau de Vilanova de Lleida
  • Hospital 12 de Octubre
  • Hospital Son Dureta
  • Hospital Clínico Universitario de Salamanca
  • Hospital Virgen Macarena
  • Hospital Mutua de Terrassa
  • Hospital Clínico Universitario de Valencia
  • Hospital General Universitario de Valencia
  • Hospital Clínico Universitario Lozano Blesa
  • Broomfield Hospital
  • Christie Hospital NHS Trust
  • Guy's Hospital
  • Royal Free Hospital

Outcomes

Primary Outcome Measures

Progression-Free Survival

Secondary Outcome Measures

Overall Survival
Safety

Full Information

First Posted
February 17, 2006
Last Updated
March 30, 2009
Sponsor
Sopherion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00294996
Brief Title
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

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sopherion Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Metastatic Her2+ Breast cancer, Myocet, liposomal doxorubicin, trastuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Myocet
Primary Outcome Measure Information:
Title
Progression-Free Survival
Secondary Outcome Measure Information:
Title
Overall Survival
Title
Safety

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Baselga, M.D.
Organizational Affiliation
Vall d'Hebron Hospital, Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Cancer Center Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Northwest Hematology/Oncology Associates
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Osceola Cancer Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
UM/Sylvester Cancer Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Clintell, Inc
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Hutchinson Clinic P.A.
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Western Maryland Health System
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Brody School of Medicine @ ECU
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Aultman Hospital Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Hematology Oncology Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Vita Hematology Oncology
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Hematology & Oncology Associates of NEPA
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
PA Oncology Hematology Asso
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
M. Francisco Gonzalez
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Sioux Valley Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Centro Oncologico de Excelencia
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Enrique Tornú
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Interzonal Gral de Agudos " EVITA"
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Profesor A. Posadas
City
Buenos Aires
Country
Argentina
Facility Name
Santorio Municipal Dr. J. Mendez
City
Buenos Aires
Country
Argentina
Facility Name
Unidad Oncologica del Neuquen
City
Neuquen
Country
Argentina
Facility Name
CAICI Instituto
City
Santa Fe
Country
Argentina
Facility Name
Centro Oncologico Rosario
City
Santa Fe
Country
Argentina
Facility Name
ISIS Clinica Especializada
City
Santa Fe
Country
Argentina
Facility Name
Ceten
City
Villa Dominico
Country
Argentina
Facility Name
Dr. Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
London Regional Cancer Centre/London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHUM Hospital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S47 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Hopital du St. Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
U.K Charité, Campus Mitte
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Gemeinschaftspraxis Gynäkologie & Geburtshilfe
City
Mannheim
Country
Germany
Facility Name
Frauenklinik von Roten Kreuz
City
München
Country
Germany
Facility Name
Klinikum Offenbach
City
Offenbach
Country
Germany
Facility Name
Üniversitäts Klinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
Dr. Horst Schmidt Kliniken
City
Wiesbaden
Country
Germany
Facility Name
Gujarat Cancer Research Institute
City
Asarwa
State/Province
Gujarat
Country
India
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
Country
India
Facility Name
Manipal Hospital
City
Bangalore
Country
India
Facility Name
Apollo Specialty Hospitals, Chennai
City
Chennai
Country
India
Facility Name
Nizam's Institute of Medical Science
City
Hyderabaad
Country
India
Facility Name
SMSMedicalCollegeHospital,
City
Jaipur
Country
India
Facility Name
Lakeshore Hospital and Research Centre Ltd
City
Kerala
Country
India
Facility Name
Himadri cancer welfare trusr
City
Kolkata
Country
India
Facility Name
Orchid Nursing Home,
City
Kolkata
Country
India
Facility Name
Ruby Hall Clinic
City
Maharashtra
Country
India
Facility Name
Tata Memorial Hospital
City
Maharashtra
Country
India
Facility Name
Kasturba Medical College,
City
Mangalore
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
Country
India
Facility Name
Batra Hospital & Medical Research Center
City
New Delhi
Country
India
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
Country
India
Facility Name
Safdarjung Hospital & Vardhaman Mahaveer Medical College
City
New Delhi
Country
India
Facility Name
Fortis Hospital
City
Noida
Country
India
Facility Name
Azienda Ospedialera Pugliese-Ciaccio
City
Catanzaro
Country
Italy
Facility Name
Clinica Oncologica Ospedale
City
Chieti
Country
Italy
Facility Name
DIMI - Università di Genova
City
Genova
Country
Italy
Facility Name
ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
City
Palermo
Country
Italy
Facility Name
Oncologia Medica
City
Pavia
Country
Italy
Facility Name
Day Hospital Oncologico,
City
Roma
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
SP SK nr1 ACK AMG
City
Gdańsk
Country
Poland
Facility Name
Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
City
Gliwice
Country
Poland
Facility Name
Samodzielny Publiczny Szpital
City
Lublin
Country
Poland
Facility Name
Zakład Opieki Zdrowotnej MSWiA
City
Olsztyn
Country
Poland
Facility Name
Szpital Wojewódzki im. Św. Łukasza
City
Tarnow
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
City
Warszawa
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
Country
Poland
Facility Name
SP ZOZ Szpital Wojewódzki
City
Zielona Gora
Country
Poland
Facility Name
Regionalny Ośrodek Onkologiczny
City
Łódź
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny
City
Świdnica
Country
Poland
Facility Name
nstituto Português de Oncologia Francisco Gentil
City
Lisbon
Country
Portugal
Facility Name
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 Name
State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences
City
Moscow
Country
Russian Federation
Facility Name
State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development
City
Moscow
Country
Russian Federation
Facility Name
State Health Care Institution "Regional Clinical Oncology Dispensary"
City
Ryazan
Country
Russian Federation
Facility Name
Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
City
Sochi
Country
Russian Federation
Facility Name
St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
City
St Petersberg
Country
Russian Federation
Facility Name
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 Name
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. Petersberg
Country
Russian Federation
Facility Name
State Health Care Institution "Leningrad Regional Oncology Dispensary"
City
St. Petersburg
Country
Russian Federation
Facility Name
State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
City
Yaroslavl
Country
Russian Federation
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida
City
Lleida
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Broomfield Hospital
City
Broomfield
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Cardiff
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24401928
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. Erratum In: Ann Oncol. 2019 Jun 1;30(6):1017.
Results Reference
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Trial of Myocet in Metastatic Breast Cancer

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