Male Breast Cancer: Understanding the Biology for Improved Patient Care

September 8, 2023 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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).

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

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

  • Belgium
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium
        • Institut Jules Bordet
      • Brussels, Belgium
        • Cliniques Universitaires St. Luc
      • Brussels, Belgium
        • Hopital Universitaire Brugmann
      • Brussels, Belgium
        • Chu St Pierre
      • Edegem, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Haine St Paul, Belgium
        • Hôpital de Jolimont
      • Leuven, Belgium
        • UZ Leuven
      • Merksem, Belgium
        • ZNA Jan Palfijn
      • Namur, Belgium
        • CHU Ucl Namu - Clinique Sainte Elisabeth
      • Oostende, Belgium
        • AZ Damiaan - Campus Sint-Jozef
  • Brazil
      • Fortaleza, Brazil, 60366-045
        • Centro Regional Integrado de Oncologia
      • Porto Alegre, Brazil, 90610 000
        • Centro de Pesquisas Clínicas em Oncologia
  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospital
  • Greece
      • Athens, Greece
        • IASO general hospital
      • Athens, Greece
        • Alexandra Hospital
      • Athens, Greece
        • Hygeia Hospital
      • Athens, Greece
        • Hippokration General Hospital of Athens
      • Athens, Greece
        • Aretaieio Hospital
      • Athens, Greece
        • General Hospital of Air Force
      • Heraklion, Greece
        • University General Hospital Heraklion
      • Kifisiá, Greece
        • Agioi Anargiroi Hospital
      • Thessaloniki, Greece
        • General University Hospital Papageorgiou
      • Thessaloniki, Greece
        • Thermi Clinic
  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland
        • Beaumont Hospital
      • Dublin, Ireland
        • St. James's Hospital
      • Dublin, Ireland
        • Mater Misericordia Hospital
      • Dublin, Ireland
        • St. Vincent's Hospital
      • Waterford, Ireland
        • Waterford Regional Hospital
  • Mexico
      • Mexico, Mexico
        • Instituto Nacional de Cancerologia
  • Netherlands
      • Amsterdam, Netherlands
        • BOOG
  • Peru
      • Lima, Peru
        • Instituto De Enfermedades Neoplasicas
  • Poland
      • Gdansk, Poland
        • Medical University of Gdansk
      • Warsaw, Poland
        • Maria Sklodowska-Curie Memorial Cancer Centre
  • Portugal
      • Lisbon, Portugal
        • Champalimaud Cancer Center
      • Porto, Portugal
        • Instituto Portugues De Oncologia - Centro Do Porto
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Oncology and Radiology
  • Spain
      • Barcelona, Spain
        • Hospital General Vall D'Hebron
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
  • Sweden
      • Göteborg, Sweden
        • Swedish Association of Breast Oncologists
  • Switzerland
      • Baden, Switzerland
        • Kantonsspital Baden
      • Basel, Switzerland
        • Universitaetsspital Basel
      • Bern, Switzerland
        • Inselspital
      • Bern, Switzerland
        • Sonnenhofklinik Engeriedspital
      • Biel, Switzerland
        • Spitalzentrum Biel
      • Herisau, Switzerland
        • Kantonales Spital Herisau
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • Liestal, Switzerland
        • Cantonal Hospital Liestal
      • Luzern, Switzerland
        • Luzerner Kantonsspital
      • Mendrisio, Switzerland
        • Ospedale Beata Vergine
      • Sion, Switzerland
        • Hopital de Sion
      • St Gallen, Switzerland
        • Kantonsspital St Gallen
      • St Gallen, Switzerland
        • ZeTuP St.Gallen
      • Thun, Switzerland
        • Radio-Onkologie Berner Oberland AG
      • Winterthur, Switzerland
        • Kantonsspital Winterthur
      • Zurich, Switzerland
        • UniversitaetsSpital Zurich
  • United Kingdom
      • Birmingham, United Kingdom
        • City Hospital
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • Cardiff, United Kingdom
        • LLandough Hospital
      • Cheltenham, United Kingdom
        • Cheltenham General Hospital
      • Crewe, United Kingdom
        • Leighton Hospital
      • Dunfermline, United Kingdom
        • Queen Margaret Hospital
      • Eastbourne, United Kingdom
        • Eastbourne District General Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre
      • Glasgow, United Kingdom
        • New Victoria Hospital
      • Kilmarnock, United Kingdom
        • Crosshouse Hospital
      • Larbert, United Kingdom
        • Forth Valley Royal Hospital
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • Paisley, United Kingdom
        • Royal Alexandra Hospital
      • Stockton on Tees, United Kingdom
        • University Hospital of North Tees
      • Swindon, United Kingdom
        • The Great Western Hospital
      • Wishaw, United Kingdom
        • Wishaw General Hospital
    • West Sussex
      • Worthing, West Sussex, United Kingdom
        • Worthing Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Comprehensive Cancer Center
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama Comprehensive Cancer Cente
    • California
      • San Francisco, California, United States, 94115
        • UCSF University of California San Francisco Medical Center-Mount Zion
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Lombardi Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5264
        • Indiana University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University CRB1
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5450
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5912
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center - Memorial hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States
        • Baylor College - Ucop
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Fred Hutchison Seattle Cancer Care Alliance

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

Sampling Method

Non-Probability Sample

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.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.
Time Frame: end of study
end of study
Patient and disease characteristics.
Time Frame: end of study
end of study
Patterns of treatment offered to these patients
Time Frame: end of study
end of study
Biological characterization of the disease
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Hellenic Oncology Research Group
Latin American Cooperative Oncology Group
Hellenic Cooperative Oncology Group
Swiss Group for Clinical Cancer Research
Breast International Group
Translational Breast Cancer Research Consortium
Borstkanker Onderzoek Groep
Cancer Trials Ireland
Swedish Association of Breast Oncologists

Investigators

  • Study Chair: Fatima Cardoso, MD, Champalimaud Cancer Center (Portugal)
  • Study Chair: Sharon H. Giordano, MD, MPH, M. D. Anderson Cancer Center (TX, USA)

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

December 1, 2010

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 9, 2010

First Posted (Estimated)

April 12, 2010

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10085
  • BIG 2-07
  • TBCRC 029

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.

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