Male Breast Cancer: Understanding the Biology for Improved Patient Care

NCT01101425 | Unknown

• 3 other identifiers: EORTC-10085BIG 2-07TBCRC 029
• Study Type: observational
• Target: 200
• Locations: 15 countries
• Sites: 92

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).

Conditions

Breast Cancer

Keywords

male; breast cancer

Outcome Measures

Primary Outcomes (4)

• Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.

  end of study

• Patient and disease characteristics.

  end of study

• Patterns of treatment offered to these patients

  end of study

• Biological characterization of the disease

  End of study

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Breast International Group: collaborator
• Swiss Cancer Institute: collaborator
• Cancer Trials Ireland: collaborator
• Borstkanker Onderzoek Groep: collaborator
• Swedish Association of Breast Oncologists: collaborator
• Hellenic Cooperative Oncology Group: collaborator
• Hellenic Oncology Research Group: collaborator
• Latin American Cooperative Oncology Group: collaborator
• Translational Breast Cancer Research Consortium: collaborator

Study Sites (93)

University Of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University Of Alabama Comprehensive Cancer Cente

Birmingham, Alabama, 35294, United States

Location

UCSF University of California San Francisco Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637-1470, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202-5264, United States

Location

Johns Hopkins University CRB1

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115-5450, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5912, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center - Memorial hospital

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Baylor college of Medicine

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Baylor College - Ucop

Houston, Texas, United States

Location

Fred Hutchison Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

ZNA Middelheim

Antwerp, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CHU St Pierre

Brussels, Belgium

Location

Cliniques Universitaires St. Luc

Brussels, Belgium

Location

Hopital Universitaire Brugmann

Brussels, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Location

Hopital De Jolimont

Haine-Saint-Paul, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

ZNA Jan Palfijn

Merksem, Belgium

Location

CHU Ucl Namu - Clinique Sainte Elisabeth

Namur, Belgium

Location

AZ Damiaan - Campus Sint-Jozef

Ostend, Belgium

Location

Centro Regional Integrado de Oncologia

Fortaleza, 60366-045, Brazil

Location

Centro de Pesquisas Clinicas em Oncologia

Porto Alegre, 90610 000, Brazil

Location

Ain Shams University Hospital

Cairo, Egypt

Location

Alexandra Hospital

Athens, Greece

Location

Aretaieio Hospital

Athens, Greece

Location

General Hospital of Air Force

Athens, Greece

Location

Hippokration General Hospital Of Athens

Athens, Greece

Location

Hygeia Hospital

Athens, Greece

Location

IASO general hospital

Athens, Greece

Location

University General Hospital Heraklion

Heraklion, Greece

Location

Agioi Anargiroi Hospital

Kifissia, Greece

Location

General University Hospital Papageorgiou

Thessaloniki, Greece

Location

Thermi Clinic

Thessaloniki, Greece

Location

Cork University Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

Mater Misericordia Hospital

Dublin, Ireland

Location

St. James'S Hospital

Dublin, Ireland

Location

St. Vincent'S Hospital

Dublin, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Instituto Nacional De Cancerologia

México, Mexico

Location

BOOG

Amsterdam, Netherlands

Location

Instituto De Enfermedades Neoplasicas

Lima, Peru

Location

Medical University Of Gdansk

Gdansk, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw, Poland

Location

Champalimaud Cancer Center

Lisbon, Portugal

Location

Instituto Portugues De Oncologia - Centro Do Porto

Porto, Portugal

Location

Institute of Oncology and Radiology

Belgrade, 11000, Serbia

Location

Hospital General Vall D'Hebron

Barcelona, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

Swedish Association of Breast Oncologists

Gothenburg, Sweden

Location

Kantonsspital Baden

Baden, Switzerland

Location

Universitaetsspital Basel

Basel, Switzerland

Location

Inselspital

Bern, Switzerland

Location

Sonnenhofklinik Engeriedspital

Bern, Switzerland

Location

Spitalzentrum Biel

Biel, Switzerland

Location

Kantonales Spital Herisau

Herisau, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Cantonal Hospital Liestal

Liestal, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Ospedale Beata Vergine

Mendrisio, Switzerland

Location

Kantonsspital St Gallen

Sankt Gallen, Switzerland

Location

ZeTuP St.Gallen

Sankt Gallen, Switzerland

Location

Hopital de Sion

Sion, Switzerland

Location

Radio-Onkologie Berner Oberland AG

Thun, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Switzerland

Location

UniversitaetsSpital Zurich

Zurich, Switzerland

Location

Worthing Hospital

Worthing, West Sussex, United Kingdom

Location

City Hospital

Birmingham, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

LLandough Hospital

Cardiff, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, United Kingdom

Location

Leighton Hospital

Crewe, United Kingdom

Location

Queen Margaret Hospital

Dunfermline, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

New Victoria Hospital

Glasgow, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, United Kingdom

Location

Forth Valley Royal Hospital

Larbert, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

Royal Alexandra Hospital

Paisley, United Kingdom

Location

University Hospital of North Tees

Stockton-on-Tees, United Kingdom

Location

The Great Western Hospital

Swindon, United Kingdom

Location

Wishaw General Hospital

Wishaw, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fatima Cardoso, MD

  Champalimaud Cancer Center (Portugal)

  STUDY CHAIR

• Sharon H. Giordano, MD, MPH

  M. D. Anderson Cancer Center (TX, USA)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 12, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

US (17); NL (1); GB (18); PT (2); GR (10); PE (1); BE (12); SE (1); ES (2); PL (2); CH (16); ME (1); IE (6); BR (2); EG (1)