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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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).

Official Title

Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.

Details

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.

Keywords

Breast Cancer male

Eligibility

For males ages 18 years and up

Retrospective part (closed to patients registration):

  • Men with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.
  • A FFPE tissue sample from the primary tumor (e.g. biopsy or surgery) is mandatory

Prospective part:

  • All men, with histologically proven invasive breast cancer, newly presenting at the center irrespective of the stage of disease, initial diagnosis date or treatment received.
  • patients cannot be registered in both the retrospective and protective parts of the study
  • patients who newly present at the center in the 3 months prior to center activation are still eligible as long as they were not previously included in the retrospective part of the study
  • Before patient registration, written informed consent must be obtained according to ICH/GCP, and national/local regulations.
  • Collection of left-over FFPE and frozen tumor samples as well as blood is optional.

Both parts:

  • Concomitant DCIS or LCIS are allowed only if invasive cancer is present.
  • Patients should be 18 years or over at the time of diagnosis.
  • The study will accept all stages of disease (e.g. early BC, locally advanced and metastatic disease) independent of the treatment received. Patients with past or concurrent other malignancies are eligible.

Locations

  • Fred Hutchison Seattle Cancer Care Alliance
    Seattle, Washington, 98109-1023, United States
  • Baylor college of Medicine
    Houston, Texas, 77030, United States
  • MD Anderson Cancer Center
    Houston, Texas, 77030, United States
  • Baylor College - Ucop
    Houston, Texas, United States
  • Mayo Clinic
    Rochester, Minnesota, 55905, United States
  • Instituto Nacional De Cancerologia
    Mexico, Mexico
  • University of Chicago Medicine
    Chicago, Illinois, 60637-1470, United States
  • Indiana University Medical Center
    Indianapolis, Indiana, 46202-5264, United States
  • University Of Alabama Comprehensive Cancer Center
    Birmingham, Alabama, 35294, United States
  • University Of Alabama Comprehensive Cancer Cente
    Birmingham, Alabama, 35294, United States
  • University of Michigan
    Ann Arbor, Michigan, 48109-5912, United States
  • Duke University Medical Center
    Durham, North Carolina, 27710, United States
  • Georgetown Lombardi Comprehensive Cancer Center
    Washington, D.C., District of Columbia, 20007, United States
  • Johns Hopkins University CRB1
    Baltimore, Maryland, 21287, United States
  • Johns Hopkins University
    Baltimore, Maryland, 21287, United States
  • Memorial Sloan-Kettering Cancer Center - Memorial hospital
    New York, New York, 10065, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, 02115-5450, United States
  • Instituto De Enfermedades Neoplasicas
    Lima, Peru
  • Cork University Hospital
    Cork, Ireland
  • Beaumont Hospital
    Dublin, Ireland
  • Mater Misericordia Hospital
    Dublin, Ireland
  • St. James'S Hospital
    Dublin, Ireland
  • St. Vincent'S Hospital
    Dublin, Ireland
  • Waterford Regional Hospital
    Waterford, Ireland
  • Worthing Hospital
    Worthing, West Sussex, United Kingdom
  • City Hospital
    Birmingham, United Kingdom
  • Royal Sussex County Hospital
    Brighton, United Kingdom
  • LLandough Hospital
    Cardiff, United Kingdom
  • Cheltenham General Hospital
    Cheltenham, United Kingdom
  • Leighton Hospital
    Crewe, United Kingdom
  • Queen Margaret Hospital
    Dunfermline, United Kingdom
  • Eastbourne District General Hospital
    Eastbourne, United Kingdom
  • Western General Hospital
    Edinburgh, United Kingdom
  • Beatson West of Scotland Cancer Centre
    Glasgow, United Kingdom
  • New Victoria Hospital
    Glasgow, United Kingdom
  • Crosshouse Hospital
    Kilmarnock, United Kingdom
  • Forth Valley Royal Hospital
    Larbert, United Kingdom
  • Royal Liverpool University Hospital
    Liverpool, United Kingdom
  • Royal Alexandra Hospital
    Paisley, United Kingdom
  • University Hospital of North Tees
    Stockton on Tees, United Kingdom
  • The Great Western Hospital
    Swindon, United Kingdom
  • Wishaw General Hospital
    Wishaw, United Kingdom
  • Swedish Association of Breast Oncologists
    Sweden, Sweden
  • Centro Regional Integrado de Oncologia
    Fortaleza, 60366-045, Brazil
  • Centro de Pesquisas Clinicas em Oncologia
    Porto Alegre, 90610 000, Brazil
  • BOOG
    Amsterdam, Netherlands
  • ZNA Middelheim
    Antwerpen, Belgium
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
  • CHU St Pierre
    Brussels, Belgium
  • Cliniques Universitaires St. Luc
    Brussels, Belgium
  • Hopital Universitaire Brugmann
    Brussels, Belgium
  • Institut Jules Bordet
    Brussels, Belgium
  • Universitair Ziekenhuis Antwerpen
    Edegem, Belgium
  • Hopital De Jolimont
    Haine St Paul, Belgium
  • UZ Leuven
    Leuven, Belgium
  • ZNA Jan Palfijn
    Merksem, Belgium
  • CHU Ucl Namu - Clinique Sainte Elisabeth
    Namur, Belgium
  • AZ Damiaan - Campus Sint-Jozef
    Oostende, Belgium
  • Champalimaud Cancer Center
    Lisbon, Portugal
  • Instituto Portugues De Oncologia - Centro Do Porto
    Porto, Portugal
  • Hospital General Vall D'Hebron
    Barcelona, Spain
  • Hospital Universitario 12 De Octubre
    Madrid, Spain
  • Medical University Of Gdansk
    Gdansk, Poland
  • Maria Sklodowska-Curie Memorial Cancer Centre
    Warsaw, Poland
  • Kantonsspital Baden
    Baden, Switzerland
  • Universitaetsspital Basel
    Basel, Switzerland
  • Inselspital
    Bern, Switzerland
  • Sonnenhofklinik Engeriedspital
    Bern, Switzerland
  • Spitalzentrum Biel
    Biel, Switzerland
  • Kantonales Spital Herisau
    Herisau, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, Switzerland
  • Cantonal Hospital Liestal
    Liestal, Switzerland
  • Luzerner Kantonsspital
    Luzern, Switzerland
  • Ospedale Beata Vergine
    Mendrisio, Switzerland
  • Hopital de Sion
    Sion, Switzerland
  • Kantonsspital St Gallen
    St Gallen, Switzerland
  • ZeTuP St.Gallen
    St Gallen, Switzerland
  • Radio-Onkologie Berner Oberland AG
    Thun, Switzerland
  • Kantonsspital Winterthur
    Winterthur, Switzerland
  • UniversitaetsSpital Zurich
    Zurich, Switzerland
  • Institute of Oncology and Radiology
    Belgrade, 11000, Serbia
  • Alexandra Hospital
    Athens, Greece
  • Aretaieio Hospital
    Athens, Greece
  • General Hospital of Air Force
    Athens, Greece
  • Hippokration General Hospital Of Athens
    Athens, Greece
  • Hygeia Hospital
    Athens, Greece
  • IASO general hospital
    Athens, Greece
  • University General Hospital Heraklion
    Heraklion, Greece
  • Agioi Anargiroi Hospital
    Nea Kifissia, Greece
  • General University Hospital Papageorgiou
    Thessaloniki, Greece
  • Thermi Clinic
    Thessaloniki, Greece
  • Ain Shams University Hospital
    Cairo, Egypt

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
ID
NCT01101425
Study Type
Observational [Patient Registry]
Last Updated
September 1, 2017