Trial of Myocet in Metastatic Breast Cancer

March 30, 2009 updated by: Sopherion Therapeutics

A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Breast Cancer

Intervention / Treatment

Drug: Myocet

Study Type

Interventional

Enrollment (Actual)

363

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Centro Oncológico 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
  - Neuquen, Argentina
    - Unidad Oncologica del Neuquen
  - Santa Fe, Argentina
    - ISIS Clinica Especializada
  - Santa Fe, Argentina
    - CAICI Instituto
  - Santa Fe, Argentina
    - Centro Oncologico Rosario
  - Villa Dominico, Argentina
    - Ceten
Canada
- - Quebec, Canada, G1S 4L8
    - Hopital du St. Sacrement
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 8X3
    - Dr. Leon Richard Oncology Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - QEII Health Sciences Centre
- Ontario
  - London, Ontario, Canada, N6A 4L6
    - London Regional Cancer Centre/London Health Science Centre
  - Ottawa, Ontario, Canada, K1H 8L6
    - The Ottawa Hospital Regional Cancer Center
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
- Quebec
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
  - Montreal, Quebec, Canada, H2L 4M1
    - CHUM Hospital Notre-Dame
- Saskatchewan
  - Regina, Saskatchewan, Canada, S47 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
Germany
- - Berlin, Germany
    - U.K Charité, Campus Mitte
  - Magdeburg, Germany
    - Universitätsklinikum Magdeburg
  - Mannheim, Germany
    - Gemeinschaftspraxis Gynäkologie & Geburtshilfe
  - München, Germany
    - Frauenklinik von Roten Kreuz
  - Offenbach, Germany
    - Klinikum Offenbach
  - Tübingen, Germany
    - Universitäts Klinikum Tübingen
  - Wiesbaden, Germany
    - Dr. Horst Schmidt Kliniken
India
- - Bangalore, India
    - Manipal Hospital
  - Bangalore, India
    - Kidwai Memorial Institute of Oncology
  - Chennai, India
    - Apollo Specialty Hospitals, Chennai
  - Hyderabaad, India
    - Nizam's Institute of Medical Science
  - Jaipur, India
    - SMSMedicalCollegeHospital,
  - Kerala, India
    - Lakeshore Hospital and Research Centre Ltd
  - Kolkata, India
    - Himadri cancer welfare trusr
  - Kolkata, India
    - Orchid Nursing Home,
  - Maharashtra, India
    - Ruby Hall Clinic
  - Maharashtra, India
    - Tata Memorial Hospital
  - Mangalore, India
    - Kasturba Medical College,
  - Mumbai, India
    - Jaslok Hospital and Research Centre
  - New Delhi, India
    - Batra Hospital & Medical Research Center
  - New Delhi, India
    - Indraprastha Apollo Hospitals
  - New Delhi, India
    - Safdarjung Hospital & Vardhaman Mahaveer Medical College
  - Noida, India
    - Fortis Hospital
- Gujarat
  - Asarwa, Gujarat, India
    - Gujarat Cancer Research Institute
Italy
- - Catanzaro, Italy
    - Azienda Ospedialera Pugliese-Ciaccio
  - Chieti, Italy
    - Clinica Oncologica Ospedale
  - Genova, Italy
    - DIMI - Università di Genova
  - Palermo, Italy
    - ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
  - Pavia, Italy
    - Oncologia Medica
  - Roma, Italy
    - Day Hospital Oncologico,
  - Rozzano, Italy
    - Istituto Clinico Humanitas
Poland
- - Gdańsk, Poland
    - SP SK nr1 ACK AMG
  - Gliwice, Poland
    - Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
  - Lublin, Poland
    - Samodzielny Publiczny Szpital
  - Olsztyn, Poland
    - Zakład Opieki Zdrowotnej MSWiA
  - Tarnow, Poland
    - Szpital Wojewódzki im. Św. Łukasza
  - Warszawa, Poland
    - Wojskowy Instytut Medyczny
  - Warszawa, Poland
    - Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
  - Zielona Gora, Poland
    - SP ZOZ Szpital Wojewódzki
  - Łódź, Poland
    - Regionalny Osrodek Onkologiczny
  - Świdnica, Poland
    - Regionalny Szpital Specjalistyczny
Portugal
- - Lisbon, Portugal
    - nstituto Português de Oncologia Francisco Gentil
Russian Federation
- - 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 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
  - Ryazan, Russian Federation
    - State Health Care Institution "Regional Clinical Oncology Dispensary"
  - Sochi, Russian Federation
    - Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
  - St Petersberg, 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. Petersburg, Russian Federation
    - State Health Care Institution "Leningrad Regional Oncology Dispensary"
  - Yaroslavl, Russian Federation
    - State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
Spain
- - Barcelona, Spain
    - Hospital de La Santa Creu i Sant Pau
  - Barcelona, Spain
    - Hospital Universitario Vall d'Hebron
  - Lleida, Spain
    - Hospital Universitari Arnau de Vilanova de Lleida
  - Madrid, Spain
    - Hospital 12 de Octubre
  - Palma de Mallorca, Spain
    - Hospital Son Dureta
  - Salamanca, Spain
    - Hospital Clinico Universitario de Salamanca
  - Sevilla, Spain
    - Hospital Virgen Macarena
  - Terrassa, Spain
    - Hospital Mútua de Terrassa
  - Valencia, Spain
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spain
    - Hospital General Universitario de Valencia
  - Zaragoza, Spain
    - Hospital Clínico Universitario Lozano Blesa
United Kingdom
- - Broomfield, United Kingdom
    - Broomfield Hospital
  - Cardiff, United Kingdom
    - Christie Hospital Nhs Trust
  - London, United Kingdom
    - Royal Free Hospital
  - London, United Kingdom
    - Guy's Hospital
United States
- California
  - San Diego, California, United States, 92121
    - Scripps Cancer Center Clinical Research
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado
- Florida
  - Coral Springs, Florida, United States, 33065
    - Northwest Hematology/Oncology Associates
  - Kissimmee, Florida, United States, 34741
    - Osceola Cancer Center
  - Plantation, Florida, United States, 33324
    - UM/Sylvester Cancer Center
- Georgia
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
- Illinois
  - Skokie, Illinois, United States, 60076
    - Clintell, Inc
- Kansas
  - Hutchinson, Kansas, United States, 67502
    - Hutchinson Clinic P.A.
- Maryland
  - Cumberland, Maryland, United States, 21502
    - Western Maryland Health System
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Brody School of Medicine @ ECU
- Ohio
  - Canton, Ohio, United States, 44710
    - Aultman Hospital Cancer Center
  - Columbus, Ohio, United States, 43235
    - Hematology Oncology Consultants, Inc.
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - Vita Hematology Oncology
  - Dunmore, Pennsylvania, United States, 18512
    - Hematology & Oncology Associates of NEPA
  - Philadelphia, Pennsylvania, United States, 19106
    - PA Oncology Hematology Asso
- South Carolina
  - Columbia, South Carolina, United States, 29203
    - M. Francisco Gonzalez
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Sioux Valley Clinic
- Tennessee
  - Knoxville, Tennessee, United States, 37920
    - Tennessee Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-Free Survival

Secondary Outcome Measures

Outcome Measure
Safety
Overall Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sopherion Therapeutics

Investigators

Principal Investigator: Jose Baselga, M.D., Vall d'Hebron Hospital, Barcelona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

STM01-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.