Breast CancerNCT01101425
Male Breast Cancer: Understanding the Biology for Improved Patient Care
An observational study of Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 93 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 93 sitesin 16 countries
- Study dates
- Dec 2010to 31 Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective part: males with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010. 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.
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.
Trial locations and contacts
93 sites in 16 countries.
93 sites in 16 countries
United Kingdom18 sites
City Hospital
Birmingham
Royal Sussex County Hospital
Brighton
LLandough Hospital
Cardiff
Cheltenham General Hospital
Cheltenham
Leighton Hospital
Crewe
Queen Margaret Hospital
Dunfermline
Eastbourne District General Hospital
Eastbourne
Western General Hospital
Edinburgh
Beatson West of Scotland Cancer Centre
Glasgow
New Victoria Hospital
Glasgow
Crosshouse Hospital
Kilmarnock
Forth Valley Royal Hospital
Larbert
Royal Liverpool University Hospital
Liverpool
Royal Alexandra Hospital
Paisley
University Hospital of North Tees
Stockton-on-Tees
The Great Western Hospital
Swindon
Wishaw General Hospital
Wishaw
Worthing Hospital
Worthing, West Sussex
United States17 sites
University of Michigan
Ann Arbor, Michigan, 48109-5912
Johns Hopkins University CRB1
Baltimore, Maryland, 21287
Johns Hopkins University
Baltimore, Maryland, 21287
University Of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
University Of Alabama Comprehensive Cancer Cente
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-5450
University of Chicago Medicine
Chicago, Illinois, 60637-1470
Duke University Medical Center
Durham, North Carolina, 27710
Baylor college of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Baylor College - Ucop
Houston, Texas
Indiana University Medical Center
Indianapolis, Indiana, 46202-5264
Memorial Sloan-Kettering Cancer Center - Memorial hospital
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco, California, 94115
Fred Hutchison Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Switzerland16 sites
Kantonsspital Baden
Baden
Universitaetsspital Basel
Basel
Inselspital
Bern
Sonnenhofklinik Engeriedspital
Bern
Spitalzentrum Biel
Biel
Kantonales Spital Herisau
Herisau
Centre Hospitalier Universitaire Vaudois
Lausanne
Cantonal Hospital Liestal
Liestal
Luzerner Kantonsspital
Lucerne
Ospedale Beata Vergine
Mendrisio
Kantonsspital St Gallen
Sankt Gallen
ZeTuP St.Gallen
Sankt Gallen
Hopital de Sion
Sion
Radio-Onkologie Berner Oberland AG
Thun
Kantonsspital Winterthur
Winterthur
UniversitaetsSpital Zurich
Zurich
Belgium12 sites
ZNA Middelheim
Antwerp
Cliniques Universitaires Saint-Luc
Brussels, 1200
CHU St Pierre
Brussels
Cliniques Universitaires St. Luc
Brussels
Hopital Universitaire Brugmann
Brussels
Institut Jules Bordet
Brussels
Universitair Ziekenhuis Antwerpen
Edegem
Hopital De Jolimont
Haine-Saint-Paul
UZ Leuven
Leuven
ZNA Jan Palfijn
Merksem
CHU Ucl Namu - Clinique Sainte Elisabeth
Namur
AZ Damiaan - Campus Sint-Jozef
Ostend
Greece10 sites
Alexandra Hospital
Athens
Aretaieio Hospital
Athens
General Hospital of Air Force
Athens
Hippokration General Hospital Of Athens
Athens
Hygeia Hospital
Athens
IASO general hospital
Athens
University General Hospital Heraklion
Heraklion
Agioi Anargiroi Hospital
Kifissia
General University Hospital Papageorgiou
Thessaloniki
Thermi Clinic
Thessaloniki
Ireland6 sites
Cork University Hospital
Cork
Beaumont Hospital
Dublin
Mater Misericordia Hospital
Dublin
St. James'S Hospital
Dublin
St. Vincent'S Hospital
Dublin
Waterford Regional Hospital
Waterford
Brazil2 sites
Centro Regional Integrado de Oncologia
Fortaleza, 60366-045
Centro de Pesquisas Clinicas em Oncologia
Porto Alegre, 90610 000
Poland2 sites
Medical University Of Gdansk
Gdansk
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw
Portugal2 sites
Champalimaud Cancer Center
Lisbon
Instituto Portugues De Oncologia - Centro Do Porto
Porto
Spain2 sites
Hospital General Vall D'Hebron
Barcelona
Hospital Universitario 12 De Octubre
Madrid
About this study
Official title: Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
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).
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- male, breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.
Measured: end of study
Patient and disease characteristics.
Measured: end of study
Patterns of treatment offered to these patients
Measured: end of study
Biological characterization of the disease
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startDec 2010
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Breast International Group, Swiss Cancer Institute, Cancer Trials Ireland, Borstkanker Onderzoek Groep, Swedish Association of Breast Oncologists, Hellenic Cooperative Oncology Group, Hellenic Oncology Research Group, Latin American Cooperative Oncology Group, Translational Breast Cancer Research Consortium
- Responsible party
- Sponsor
- Investigators
- Fatima Cardoso, MD, Study chair, Champalimaud Cancer Center (Portugal)Sharon H. Giordano, MD, MPH, Study chair, M. D. Anderson Cancer Center (TX, USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101425
- Sponsor's protocol ID
- EORTC-10085
- Other IDs
- BIG 2-07, TBCRC 029
- Status last verified
- May 2026
- First submitted
- 9 Apr 2010
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
- ClinicalTrials.gov ID
- NCT01101425
- Acronym / sponsor ID
- EORTC-10085
- Conditions
- Breast Cancer
- Keywords
- male, breast cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Breast International Group, Swiss Cancer Institute, Cancer Trials Ireland, Borstkanker Onderzoek Groep, Swedish Association of Breast Oncologists, Hellenic Cooperative Oncology Group, Hellenic Oncology Research Group, Latin American Cooperative Oncology Group, Translational Breast Cancer Research Consortium
- Study start
- Dec 2010
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective part: males with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.
Time frame: end of study
Patient and disease characteristics.
Time frame: end of study
Patterns of treatment offered to these patients
Time frame: end of study
Biological characterization of the disease
Time frame: End of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Cardoso, MD study chair
Champalimaud Cancer Center (Portugal)
Sharon H. Giordano, MD, MPH study chair
M. D. Anderson Cancer Center (TX, USA)
93 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 93 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United Kingdom, United States, Switzerland, Belgium, Greece and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. (time frame: end of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.