Male Breast Cancer: Understanding the Biology for Improved Patient Care

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01101425
Collaborator
Breast International Group (Other), Swiss Group for Clinical Cancer Research (Other), Cancer Trials Ireland (Other), Borstkanker Onderzoek Groep (Other), Swedish Association of Breast Oncologists (Other), Hellenic Cooperative Oncology Group (Other), Hellenic Oncology Research Group (Other), Latin American Cooperative Oncology Group (Other), Translational Breast Cancer Research Consortium (Other)
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Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
    Study Start Date :
    Dec 1, 2010
    Anticipated Primary Completion Date :
    Feb 1, 2027
    Anticipated Study Completion Date :
    Mar 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. [end of study]

    2. Patient and disease characteristics. [end of study]

    3. Patterns of treatment offered to these patients [end of study]

    4. Biological characterization of the disease [End of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Alabama Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 University Of Alabama Comprehensive Cancer Cente Birmingham Alabama United States 35294
    3 UCSF University of California San Francisco Medical Center-Mount Zion San Francisco California United States 94115
    4 Georgetown Lombardi Comprehensive Cancer Center Washington District of Columbia United States 20007
    5 University of Chicago Medicine Chicago Illinois United States 60637-1470
    6 Indiana University Medical Center Indianapolis Indiana United States 46202-5264
    7 Johns Hopkins University CRB1 Baltimore Maryland United States 21287
    8 Johns Hopkins University Baltimore Maryland United States 21287
    9 Dana-Farber Cancer Institute Boston Massachusetts United States 02115-5450
    10 University of Michigan Ann Arbor Michigan United States 48109-5912
    11 Mayo Clinic Rochester Minnesota United States 55905
    12 Memorial Sloan-Kettering Cancer Center - Memorial hospital New York New York United States 10065
    13 Duke University Medical Center Durham North Carolina United States 27710
    14 Baylor college of Medicine Houston Texas United States 77030
    15 MD Anderson Cancer Center Houston Texas United States 77030
    16 Baylor College - Ucop Houston Texas United States
    17 Fred Hutchison Seattle Cancer Care Alliance Seattle Washington United States 98109-1023
    18 ZNA Middelheim Antwerpen Belgium
    19 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
    20 CHU St Pierre Brussels Belgium
    21 Cliniques Universitaires St. Luc Brussels Belgium
    22 Hopital Universitaire Brugmann Brussels Belgium
    23 Institut Jules Bordet Brussels Belgium
    24 Universitair Ziekenhuis Antwerpen Edegem Belgium
    25 Hopital De Jolimont Haine St Paul Belgium
    26 UZ Leuven Leuven Belgium
    27 ZNA Jan Palfijn Merksem Belgium
    28 CHU Ucl Namu - Clinique Sainte Elisabeth Namur Belgium
    29 AZ Damiaan - Campus Sint-Jozef Oostende Belgium
    30 Centro Regional Integrado de Oncologia Fortaleza Brazil 60366-045
    31 Centro de Pesquisas Clinicas em Oncologia Porto Alegre Brazil 90610 000
    32 Ain Shams University Hospital Cairo Egypt
    33 Alexandra Hospital Athens Greece
    34 Aretaieio Hospital Athens Greece
    35 General Hospital of Air Force Athens Greece
    36 Hippokration General Hospital Of Athens Athens Greece
    37 Hygeia Hospital Athens Greece
    38 IASO general hospital Athens Greece
    39 University General Hospital Heraklion Heraklion Greece
    40 Agioi Anargiroi Hospital Kifisiá Greece
    41 General University Hospital Papageorgiou Thessaloniki Greece
    42 Thermi Clinic Thessaloniki Greece
    43 Cork University Hospital Cork Ireland
    44 Beaumont Hospital Dublin Ireland
    45 Mater Misericordia Hospital Dublin Ireland
    46 St. James'S Hospital Dublin Ireland
    47 St. Vincent'S Hospital Dublin Ireland
    48 Waterford Regional Hospital Waterford Ireland
    49 Instituto Nacional De Cancerologia Mexico Mexico
    50 BOOG Amsterdam Netherlands
    51 Instituto De Enfermedades Neoplasicas Lima Peru
    52 Medical University Of Gdansk Gdansk Poland
    53 Maria Sklodowska-Curie Memorial Cancer Centre Warsaw Poland
    54 Champalimaud Cancer Center Lisbon Portugal
    55 Instituto Portugues De Oncologia - Centro Do Porto Porto Portugal
    56 Institute of Oncology and Radiology Belgrade Serbia 11000
    57 Hospital General Vall D'Hebron Barcelona Spain
    58 Hospital Universitario 12 De Octubre Madrid Spain
    59 Swedish Association of Breast Oncologists Göteborg Sweden
    60 Kantonsspital Baden Baden Switzerland
    61 Universitaetsspital Basel Basel Switzerland
    62 Inselspital Bern Switzerland
    63 Sonnenhofklinik Engeriedspital Bern Switzerland
    64 Spitalzentrum Biel Biel Switzerland
    65 Kantonales Spital Herisau Herisau Switzerland
    66 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland
    67 Cantonal Hospital Liestal Liestal Switzerland
    68 Luzerner Kantonsspital Luzern Switzerland
    69 Ospedale Beata Vergine Mendrisio Switzerland
    70 Hopital de Sion Sion Switzerland
    71 Kantonsspital St Gallen St Gallen Switzerland
    72 ZeTuP St.Gallen St Gallen Switzerland
    73 Radio-Onkologie Berner Oberland AG Thun Switzerland
    74 Kantonsspital Winterthur Winterthur Switzerland
    75 UniversitaetsSpital Zurich Zurich Switzerland
    76 Worthing Hospital Worthing West Sussex United Kingdom
    77 City Hospital Birmingham United Kingdom
    78 Royal Sussex County Hospital Brighton United Kingdom
    79 LLandough Hospital Cardiff United Kingdom
    80 Cheltenham General Hospital Cheltenham United Kingdom
    81 Leighton Hospital Crewe United Kingdom
    82 Queen Margaret Hospital Dunfermline United Kingdom
    83 Eastbourne District General Hospital Eastbourne United Kingdom
    84 Western General Hospital Edinburgh United Kingdom
    85 Beatson West of Scotland Cancer Centre Glasgow United Kingdom
    86 New Victoria Hospital Glasgow United Kingdom
    87 Crosshouse Hospital Kilmarnock United Kingdom
    88 Forth Valley Royal Hospital Larbert United Kingdom
    89 Royal Liverpool University Hospital Liverpool United Kingdom
    90 Royal Alexandra Hospital Paisley United Kingdom
    91 University Hospital of North Tees Stockton on Tees United Kingdom
    92 The Great Western Hospital Swindon United Kingdom
    93 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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Organisation for Research and Treatment of Cancer - EORTC
    ClinicalTrials.gov Identifier:
    NCT01101425
    Other Study ID Numbers:
    • EORTC-10085
    • BIG 2-07
    • TBCRC 029
    First Posted:
    Apr 12, 2010
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2021