- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00294996
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
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
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Buenos Aires, Argentina
- Centro Oncológico de Excelencia
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Buenos Aires, Argentina
- Hospital Enrique Tornú
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Buenos Aires, Argentina
- Hospital Interzonal Gral de Agudos " EVITA"
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Buenos Aires, Argentina
- Hospital Profesor A. Posadas
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Buenos Aires, Argentina
- Santorio Municipal Dr. J. Mendez
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Neuquen, Argentina
- Unidad Oncologica del Neuquen
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Santa Fe, Argentina
- ISIS Clinica Especializada
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Santa Fe, Argentina
- CAICI Instituto
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Santa Fe, Argentina
- Centro Oncologico Rosario
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Villa Dominico, Argentina
- Ceten
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Quebec, Canada, G1S 4L8
- Hopital du St. Sacrement
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
- Dr. Leon Richard Oncology Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- QEII Health Sciences Centre
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Centre/London Health Science Centre
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital Regional Cancer Center
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H2L 4M1
- CHUM Hospital Notre-Dame
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Saskatchewan
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Regina, Saskatchewan, Canada, S47 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Berlin, Germany
- U.K Charité, Campus Mitte
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Magdeburg, Germany
- Universitätsklinikum Magdeburg
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Mannheim, Germany
- Gemeinschaftspraxis Gynäkologie & Geburtshilfe
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München, Germany
- Frauenklinik von Roten Kreuz
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Offenbach, Germany
- Klinikum Offenbach
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Tübingen, Germany
- Universitäts Klinikum Tübingen
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Wiesbaden, Germany
- Dr. Horst Schmidt Kliniken
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Bangalore, India
- Manipal Hospital
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Bangalore, India
- Kidwai Memorial Institute of Oncology
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Chennai, India
- Apollo Specialty Hospitals, Chennai
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Hyderabaad, India
- Nizam's Institute of Medical Science
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Jaipur, India
- SMSMedicalCollegeHospital,
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Kerala, India
- Lakeshore Hospital and Research Centre Ltd
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Kolkata, India
- Himadri cancer welfare trusr
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Kolkata, India
- Orchid Nursing Home,
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Maharashtra, India
- Ruby Hall Clinic
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Maharashtra, India
- Tata Memorial Hospital
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Mangalore, India
- Kasturba Medical College,
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Mumbai, India
- Jaslok Hospital and Research Centre
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New Delhi, India
- Batra Hospital & Medical Research Center
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New Delhi, India
- Indraprastha Apollo Hospitals
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New Delhi, India
- Safdarjung Hospital & Vardhaman Mahaveer Medical College
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Noida, India
- Fortis Hospital
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Gujarat
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Asarwa, Gujarat, India
- Gujarat Cancer Research Institute
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Catanzaro, Italy
- Azienda Ospedialera Pugliese-Ciaccio
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Chieti, Italy
- Clinica Oncologica Ospedale
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Genova, Italy
- DIMI - Università di Genova
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Palermo, Italy
- ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
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Pavia, Italy
- Oncología Médica
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Roma, Italy
- Day Hospital Oncologico,
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Rozzano, Italy
- Istituto Clinico Humanitas
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Gdańsk, Poland
- SP SK nr1 ACK AMG
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Gliwice, Poland
- Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
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Lublin, Poland
- Samodzielny Publiczny Szpital
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Olsztyn, Poland
- Zakład Opieki Zdrowotnej MSWiA
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Tarnow, Poland
- Szpital Wojewódzki im. Św. Łukasza
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Warszawa, Poland
- Wojskowy Instytut Medyczny
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Warszawa, Poland
- Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
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Zielona Gora, Poland
- SP ZOZ Szpital Wojewódzki
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Łódź, Poland
- Regionalny Ośrodek Onkologiczny
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Świdnica, Poland
- Regionalny Szpital Specjalistyczny
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Lisbon, Portugal
- nstituto Português de Oncologia Francisco Gentil
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Moscow, Russian Federation
- Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company
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Moscow, Russian Federation
- State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences
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Moscow, Russian Federation
- State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development
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Ryazan, Russian Federation
- State Health Care Institution "Regional Clinical Oncology Dispensary"
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Sochi, Russian Federation
- Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
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St Petersberg, Russian Federation
- St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
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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
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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
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St. Petersburg, Russian Federation
- State Health Care Institution "Leningrad Regional Oncology Dispensary"
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Yaroslavl, Russian Federation
- State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
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Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Spain
- Hospital Universitario Vall d'Hebron
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Lleida, Spain
- Hospital Universitari Arnau de Vilanova de Lleida
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Madrid, Spain
- Hospital 12 de Octubre
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Palma de Mallorca, Spain
- Hospital Son Dureta
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Salamanca, Spain
- Hospital Clinico Universitario de Salamanca
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Sevilla, Spain
- Hospital Virgen Macarena
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Terrassa, Spain
- Hospital Mutua De Terrassa
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Valencia, Spain
- Hospital Clinico Universitario de Valencia
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Valencia, Spain
- Hospital General Universitario de Valencia
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Zaragoza, Spain
- Hospital Clinico Universitario Lozano Blesa
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Broomfield, United Kingdom
- Broomfield Hospital
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Cardiff, United Kingdom
- Christie Hospital NHS Trust
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London, United Kingdom
- Royal Free Hospital
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London, United Kingdom
- Guy's Hospital
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California
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San Diego, California, United States, 92121
- Scripps Cancer Center Clinical Research
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Florida
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Coral Springs, Florida, United States, 33065
- Northwest Hematology/Oncology Associates
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Kissimmee, Florida, United States, 34741
- Osceola Cancer Center
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Plantation, Florida, United States, 33324
- UM/Sylvester Cancer Center
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Georgia
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Columbus, Georgia, United States, 31904
- John B. Amos Cancer Center
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Illinois
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Skokie, Illinois, United States, 60076
- Clintell, Inc
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Kansas
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Hutchinson, Kansas, United States, 67502
- Hutchinson Clinic P.A.
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Maryland
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Cumberland, Maryland, United States, 21502
- Western Maryland Health System
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North Carolina
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Greenville, North Carolina, United States, 27834
- Brody School of Medicine @ ECU
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Ohio
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Canton, Ohio, United States, 44710
- Aultman Hospital Cancer Center
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Columbus, Ohio, United States, 43235
- Hematology Oncology Consultants, Inc.
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- Vita Hematology Oncology
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Dunmore, Pennsylvania, United States, 18512
- Hematology & Oncology Associates of NEPA
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Philadelphia, Pennsylvania, United States, 19106
- PA Oncology Hematology Asso
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South Carolina
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Columbia, South Carolina, United States, 29203
- M. Francisco Gonzalez
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sioux Valley Clinic
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Tennessee
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Knoxville, Tennessee, United States, 37920
- Tennessee Cancer Specialists
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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
No
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 |
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Progression-Free Survival
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Secondary Outcome Measures
Outcome Measure |
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Safety
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Overall Survival
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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.
Clinical Trials on Breast Cancer
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
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University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of California, IrvineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast CancerUnited States
Clinical Trials on Myocet
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Istituto Scientifico Romagnolo per lo Studio e...CompletedHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastItaly
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Claudia Lorenz-SchlüterTerminatedMetastatic Breast CancerGermany
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Central Hospital, Nancy, FranceCompletedMalignant GliomaFrance
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Fondazione Italiana Linfomi ONLUSCentro di Riferimento per l'Epidemiologia e la Prev. Oncologica PiemonteCompleted
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GlaxoSmithKlineCompletedMigraine Disorders
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Cancer Trials IrelandTerminated
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Hoffmann-La RocheCompleted
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Borstkanker Onderzoek GroepRoche Pharma AG; Teva PharmaCompletedMetastatic Breast Cancer | Human Epidermal Growth Factor 2 Negative Carcinoma of BreastNetherlands
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German Breast GroupGlaxoSmithKline; Roche Pharma AG; Teva Pharmaceuticals USACompletedInflammatory Breast Cancer | HER-2 Positive Breast Cancer | Tubular Breast Cancer Stage II | Mucinous Breast Cancer Stage II | Breast Cancer Female NOS | Invasive Ductal Breast Cancer | Tubular Breast Cancer Stage III | Inflammatory Breast Cancer Stage IVGermany
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SOLTI Breast Cancer Research GroupCompleted