Male Breast Cancer: Understanding the Biology for Improved Patient Care
NCT ID: NCT01101425
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2010-12-31
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience
NCT03240510
Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007
NCT00773669
Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
NCT06133647
Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
NCT00666731
Collecting Information From Patients Enrolled in the Breast Specialized Program of Research Excellence
NCT01004562
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Breast International Group
OTHER
Swiss Cancer Institute
OTHER
Cancer Trials Ireland
NETWORK
Borstkanker Onderzoek Groep
NETWORK
Swedish Association of Breast Oncologists
UNKNOWN
Hellenic Cooperative Oncology Group
OTHER
Hellenic Oncology Research Group
OTHER
Latin American Cooperative Oncology Group
OTHER
Translational Breast Cancer Research Consortium
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fatima Cardoso, MD
Role: STUDY_CHAIR
Champalimaud Cancer Center (Portugal)
Sharon H. Giordano, MD, MPH
Role: STUDY_CHAIR
M. D. Anderson Cancer Center (TX, USA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 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
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center - Memorial hospital
New York, New York, 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
ZNA Middelheim
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , 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-Saint-Paul, , Belgium
UZ Leuven
Leuven, , Belgium
ZNA Jan Palfijn
Merksem, , Belgium
CHU Ucl Namu - Clinique Sainte Elisabeth
Namur, , Belgium
AZ Damiaan - Campus Sint-Jozef
Ostend, , Belgium
Centro Regional Integrado de Oncologia
Fortaleza, , Brazil
Centro de Pesquisas Clinicas em Oncologia
Porto Alegre, , Brazil
Ain Shams University Hospital
Cairo, , Egypt
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
Kifissia, , Greece
General University Hospital Papageorgiou
Thessaloniki, , Greece
Thermi Clinic
Thessaloniki, , Greece
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
Instituto Nacional De Cancerologia
México, , Mexico
BOOG
Amsterdam, , Netherlands
Instituto De Enfermedades Neoplasicas
Lima, , Peru
Medical University Of Gdansk
Gdansk, , Poland
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, , Poland
Champalimaud Cancer Center
Lisbon, , Portugal
Instituto Portugues De Oncologia - Centro Do Porto
Porto, , Portugal
Institute of Oncology and Radiology
Belgrade, , Serbia
Hospital General Vall D'Hebron
Barcelona, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Swedish Association of Breast Oncologists
Gothenburg, , Sweden
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
Lucerne, , Switzerland
Ospedale Beata Vergine
Mendrisio, , Switzerland
Kantonsspital St Gallen
Sankt Gallen, , Switzerland
ZeTuP St.Gallen
Sankt Gallen, , Switzerland
Hopital de Sion
Sion, , Switzerland
Radio-Onkologie Berner Oberland AG
Thun, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
UniversitaetsSpital Zurich
Zurich, , Switzerland
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIG 2-07
Identifier Type: -
Identifier Source: secondary_id
TBCRC 029
Identifier Type: -
Identifier Source: secondary_id
EORTC-10085
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.