Trial of Myocet in Metastatic Breast Cancer

NCT ID: NCT00294996

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Metastatic Her2+ Breast cancer Myocet liposomal doxorubicin trastuzumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Myocet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sopherion Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jose Baselga, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron Hospital, Barcelona, Spain

Locations

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Scripps Cancer Center Clinical Research

San Diego, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Northwest Hematology/Oncology Associates

Coral Springs, Florida, United States

Site Status

Osceola Cancer Center

Kissimmee, Florida, United States

Site Status

UM/Sylvester Cancer Center

Plantation, Florida, United States

Site Status

John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status

Clintell, Inc

Skokie, Illinois, United States

Site Status

Hutchinson Clinic P.A.

Hutchinson, Kansas, United States

Site Status

Western Maryland Health System

Cumberland, Maryland, United States

Site Status

Brody School of Medicine @ ECU

Greenville, North Carolina, United States

Site Status

Aultman Hospital Cancer Center

Canton, Ohio, United States

Site Status

Hematology Oncology Consultants, Inc.

Columbus, Ohio, United States

Site Status

Vita Hematology Oncology

Bethlehem, Pennsylvania, United States

Site Status

Hematology & Oncology Associates of NEPA

Dunmore, Pennsylvania, United States

Site Status

PA Oncology Hematology Asso

Philadelphia, Pennsylvania, United States

Site Status

M. Francisco Gonzalez

Columbia, South Carolina, United States

Site Status

Sioux Valley Clinic

Sioux Falls, South Dakota, United States

Site Status

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Site Status

Centro Oncologico de Excelencia

Buenos Aires, , Argentina

Site Status

Hospital Enrique Tornú

Buenos Aires, , Argentina

Site Status

Hospital Interzonal Gral de Agudos " EVITA"

Buenos Aires, , Argentina

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Hospital Profesor A. Posadas

Buenos Aires, , Argentina

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Santorio Municipal Dr. J. Mendez

Buenos Aires, , Argentina

Site Status

Unidad Oncologica del Neuquen

Neuquén, , Argentina

Site Status

CAICI Instituto

Santa Fe, , Argentina

Site Status

Centro Oncologico Rosario

Santa Fe, , Argentina

Site Status

ISIS Clinica Especializada

Santa Fe, , Argentina

Site Status

Ceten

Villa Domínico, , Argentina

Site Status

Dr. Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Site Status

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

London Regional Cancer Centre/London Health Science Centre

London, Ontario, Canada

Site Status

The Ottawa Hospital Regional Cancer Center

Ottawa, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CHUM Hospital Notre-Dame

Montreal, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

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Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

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Hopital du St. Sacrement

Québec, , Canada

Site Status

U.K Charité, Campus Mitte

Berlin, , Germany

Site Status

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Site Status

Gemeinschaftspraxis Gynäkologie & Geburtshilfe

Mannheim, , Germany

Site Status

Frauenklinik von Roten Kreuz

München, , Germany

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Klinikum Offenbach

Offenbach, , Germany

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Üniversitäts Klinikum Tübingen

Tübingen, , Germany

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Dr. Horst Schmidt Kliniken

Wiesbaden, , Germany

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Gujarat Cancer Research Institute

Asarwa, Gujarat, India

Site Status

Kidwai Memorial Institute of Oncology

Bangalore, , India

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Manipal Hospital

Bangalore, , India

Site Status

Apollo Specialty Hospitals, Chennai

Chennai, , India

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Nizam's Institute of Medical Science

Hyderabaad, , India

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SMSMedicalCollegeHospital,

Jaipur, , India

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Lakeshore Hospital and Research Centre Ltd

Kerala, , India

Site Status

Himadri cancer welfare trusr

Kolkata, , India

Site Status

Orchid Nursing Home,

Kolkata, , India

Site Status

Ruby Hall Clinic

Maharashtra, , India

Site Status

Tata Memorial Hospital

Maharashtra, , India

Site Status

Kasturba Medical College,

Mangalore, , India

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Jaslok Hospital and Research Centre

Mumbai, , India

Site Status

Batra Hospital & Medical Research Center

New Delhi, , India

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Indraprastha Apollo Hospitals

New Delhi, , India

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Safdarjung Hospital & Vardhaman Mahaveer Medical College

New Delhi, , India

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Fortis Hospital

Noida, , India

Site Status

Azienda Ospedialera Pugliese-Ciaccio

Catanzaro, , Italy

Site Status

Clinica Oncologica Ospedale

Chieti, , Italy

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DIMI - Università di Genova

Genova, , Italy

Site Status

ARNAS CIVICO. Presidio Ospedaliero M. Ascoli

Palermo, , Italy

Site Status

Oncologia Medica

Pavia, , Italy

Site Status

Day Hospital Oncologico,

Roma, , Italy

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Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

SP SK nr1 ACK AMG

Gdansk, , Poland

Site Status

Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice

Gliwice, , Poland

Site Status

Regionalny Ośrodek Onkologiczny

Lodz, , Poland

Site Status

Samodzielny Publiczny Szpital

Lublin, , Poland

Site Status

Zakład Opieki Zdrowotnej MSWiA

Olsztyn, , Poland

Site Status

Regionalny Szpital Specjalistyczny

Swidnica, , Poland

Site Status

Szpital Wojewódzki im. Św. Łukasza

Tarnów, , Poland

Site Status

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie

Warsaw, , Poland

Site Status

Wojskowy Instytut Medyczny

Warsaw, , Poland

Site Status

SP ZOZ Szpital Wojewódzki

Zielona Góra, , Poland

Site Status

nstituto Português de Oncologia Francisco Gentil

Lisbon, , Portugal

Site Status

Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company

Moscow, , Russia

Site Status

State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences

Moscow, , Russia

Site Status

State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development

Moscow, , Russia

Site Status

State Health Care Institution "Regional Clinical Oncology Dispensary"

Ryazan, , Russia

Site Status

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

Site Status

St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"

Saint Petersberg, , Russia

Site Status

State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development

Saint Petersberg, , Russia

Site Status

State Health Care Institution "Leningrad Regional Oncology Dispensary"

Saint Petersburg, , Russia

Site Status

Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"

Sochi, , Russia

Site Status

State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"

Yaroslavl, , Russia

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

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Hospital Universitario Vall d'Hebron

Barcelona, , Spain

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Hospital Universitari Arnau de Vilanova de Lleida

Lleida, , Spain

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Hospital 12 de Octubre

Madrid, , Spain

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Hospital Son Dureta

Palma de Mallorca, , Spain

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Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

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Hospital Virgen Macarena

Seville, , Spain

Site Status

Hospital Mutua de Terrassa

Terrassa, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

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Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status

Broomfield Hospital

Broomfield, , United Kingdom

Site Status

Christie Hospital NHS Trust

Cardiff, , United Kingdom

Site Status

Guy's Hospital

London, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United States Argentina Canada Germany India Italy Poland Portugal Russia Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24401928 (View on PubMed)

Other Identifiers

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STM01-102

Identifier Type: -

Identifier Source: org_study_id