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Male Breast Cancer: Understanding the Biology for Improved Patient Care

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ClinicalTrials.gov Identifier: NCT01101425
Recruitment Status : Active, not recruiting
First Posted : April 12, 2010
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
Breast International Group
Swiss Group for Clinical Cancer Research
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
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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).


Condition or disease
Breast Cancer

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 [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
Study Start Date : December 2010
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. [ Time Frame: end of study ]
  2. Patient and disease characteristics. [ Time Frame: end of study ]
  3. Patterns of treatment offered to these patients [ Time Frame: end of study ]
  4. Biological characterization of the disease [ Time Frame: End of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101425


  Hide Study Locations
Locations
United States, Alabama
University Of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
University Of Alabama Comprehensive Cancer Cente
Birmingham, Alabama, United States, 35294
United States, California
UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco, California, United States, 94115
United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center
Washington, D.C., District of Columbia, United States, 20007
United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-5264
United States, Maryland
Johns Hopkins University CRB1
Baltimore, Maryland, United States, 21287
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-5450
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5912
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center - Memorial hospital
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Baylor college of Medicine
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor College - Ucop
Houston, Texas, United States
United States, Washington
Fred Hutchison Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Belgium
ZNA Middelheim
Antwerpen, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
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
Brazil
Centro Regional Integrado de Oncologia
Fortaleza, Brazil, 60366-045
Centro de Pesquisas Clinicas em Oncologia
Porto Alegre, Brazil, 90610 000
Egypt
Ain Shams University Hospital
Cairo, Egypt
Greece
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
Ireland
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
Mexico
Instituto Nacional De Cancerologia
Mexico, Mexico
Netherlands
BOOG
Amsterdam, Netherlands
Peru
Instituto De Enfermedades Neoplasicas
Lima, Peru
Poland
Medical University Of Gdansk
Gdansk, Poland
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, Poland
Portugal
Champalimaud Cancer Center
Lisbon, Portugal
Instituto Portugues De Oncologia - Centro Do Porto
Porto, Portugal
Serbia
Institute of Oncology and Radiology
Belgrade, Serbia, 11000
Spain
Hospital General Vall D'Hebron
Barcelona, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Sweden
Swedish Association of Breast Oncologists
Sweden, Sweden
Switzerland
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
United Kingdom
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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Breast International Group
Swiss Group for Clinical Cancer Research
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
Investigators
Study Chair: Fatima Cardoso, MD Champalimaud Cancer Center (Portugal)
Study Chair: Sharon H. Giordano, MD, MPH M. D. Anderson Cancer Center (TX, USA)

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01101425     History of Changes
Other Study ID Numbers: EORTC-10085
BIG 2-07
TBCRC 029
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
male
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases