Male Breast Cancer: Understanding the Biology for Improved Patient Care
- Conditions
- Breast Cancer
- Registration Number
- NCT01101425
- Brief Summary
Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease.
Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010.
Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).
- Detailed Description
Objectives retrospective part (closed to patients registration in September 2013):
* To perform a large international joint retrospective analysis of clinical and biological data of male breast cancer (BC) patients treated from 1990 to 2010.
* To create a database of patient characteristics, disease features, treatments received, and clinical outcomes of a large series of men diagnosed with BC from 1990 to 2010 in centers in Europe and USA.
* To perform a central pathological review of the corresponding large series of male BC tumors to determine their biologic characteristics and identify relevant prognostic and predictive markers.
Objectives prospective part (opened early 2014):
* To run a prospective registry of all male BC patients (including newly diagnosed) irrespective of the stage and treatment, in the participating institutions for a period of 30 months; collection of FFPE, fresh frozen and blood samples is optional but highly encouraged.
* Quality of Life sub-study
The two parts of this study will provide important information regarding male BC biology and clinical evolution. The collected follow-up information will provide an overview of the current practice in the early and the advanced disease and also offer precious information of the disease evolution in such rare patients' population.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. end of study Biological characterization of the disease End of study Patient and disease characteristics. end of study Patterns of treatment offered to these patients end of study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (93)
Thermi Clinic
🇬🇷Thessaloniki, Greece
Leighton Hospital
🇬🇧Crewe, United Kingdom
Worthing Hospital
🇬🇧Worthing, West Sussex, United Kingdom
ZNA Jan Palfijn
🇧🇪Merksem, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Hygeia Hospital
🇬🇷Athens, Greece
Agioi Anargiroi Hospital
🇬🇷Kifisiá, Greece
Mater Misericordia Hospital
🇮🇪Dublin, Ireland
Waterford Regional Hospital
🇮🇪Waterford, Ireland
Hopital De Jolimont
🇧🇪Haine St Paul, Belgium
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, United Kingdom
Instituto De Enfermedades Neoplasicas
🇵🇪Lima, Peru
Queen Margaret Hospital
🇬🇧Dunfermline, United Kingdom
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Spitalzentrum Biel
🇨🇭Biel, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
City Hospital
🇬🇧Birmingham, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, United Kingdom
LLandough Hospital
🇬🇧Cardiff, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom
The Great Western Hospital
🇬🇧Swindon, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, United Kingdom
Georgetown Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Aretaieio Hospital
🇬🇷Athens, Greece
IASO general hospital
🇬🇷Athens, Greece
Beaumont Hospital
🇮🇪Dublin, Ireland
Cantonal Hospital Liestal
🇨🇭Liestal, Switzerland
ZeTuP St.Gallen
🇨🇭St Gallen, Switzerland
Sonnenhofklinik Engeriedspital
🇨🇭Bern, Switzerland
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
Hopital de Sion
🇨🇭Sion, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Memorial Sloan-Kettering Cancer Center - Memorial hospital
🇺🇸New York, New York, United States
Centro de Pesquisas Clinicas em Oncologia
🇧🇷Porto Alegre, Brazil
Cork University Hospital
🇮🇪Cork, Ireland
St. Vincent'S Hospital
🇮🇪Dublin, Ireland
Hospital General Vall D'Hebron
🇪🇸Barcelona, Spain
Kantonales Spital Herisau
🇨🇭Herisau, Switzerland
Kantonsspital St Gallen
🇨🇭St Gallen, Switzerland
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Forth Valley Royal Hospital
🇬🇧Larbert, United Kingdom
University Hospital of North Tees
🇬🇧Stockton on Tees, United Kingdom
Swedish Association of Breast Oncologists
🇸🇪Göteborg, Sweden
University Of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University Of Alabama Comprehensive Cancer Cente
🇺🇸Birmingham, Alabama, United States
UCSF University of California San Francisco Medical Center-Mount Zion
🇺🇸San Francisco, California, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University CRB1
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Baylor college of Medicine
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baylor College - Ucop
🇺🇸Houston, Texas, United States
Fred Hutchison Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
New Victoria Hospital
🇬🇧Glasgow, United Kingdom
Champalimaud Cancer Center
🇵🇹Lisbon, Portugal
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Kantonsspital Baden
🇨🇭Baden, Switzerland
Universitaetsspital Basel
🇨🇭Basel, Switzerland
Ospedale Beata Vergine
🇨🇭Mendrisio, Switzerland
Cliniques Universitaires St. Luc
🇧🇪Brussels, Belgium
AZ Damiaan - Campus Sint-Jozef
🇧🇪Oostende, Belgium
Alexandra Hospital
🇬🇷Athens, Greece
General Hospital of Air Force
🇬🇷Athens, Greece
General University Hospital Papageorgiou
🇬🇷Thessaloniki, Greece
BOOG
🇳🇱Amsterdam, Netherlands
Hippokration General Hospital Of Athens
🇬🇷Athens, Greece
University General Hospital Heraklion
🇬🇷Heraklion, Greece
Medical University Of Gdansk
🇵🇱Gdansk, Poland
Maria Sklodowska-Curie Memorial Cancer Centre
🇵🇱Warsaw, Poland
Institute of Oncology and Radiology
🇷🇸Belgrade, Serbia
Inselspital
🇨🇭Bern, Switzerland
UniversitaetsSpital Zurich
🇨🇭Zurich, Switzerland
Ain Shams University Hospital
🇪🇬Cairo, Egypt
CHU St Pierre
🇧🇪Brussels, Belgium
Hopital Universitaire Brugmann
🇧🇪Brussels, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHU Ucl Namu - Clinique Sainte Elisabeth
🇧🇪Namur, Belgium
Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, Brazil
St. James'S Hospital
🇮🇪Dublin, Ireland
Instituto Nacional De Cancerologia
🇲🇽Mexico, Mexico
Instituto Portugues De Oncologia - Centro Do Porto
🇵🇹Porto, Portugal
Radio-Onkologie Berner Oberland AG
🇨🇭Thun, Switzerland
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom