Breast Cancer Clinical Trial

Male Breast Cancer: Understanding the Biology for Improved Patient Care

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).

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Full 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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT01101425

Recruitment Status:

Active, not recruiting

Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

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There are 17 Locations for this study

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University Of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
University Of Alabama Comprehensive Cancer Cente
Birmingham Alabama, 35294, United States
UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco California, 94115, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington District of Columbia, 20007, United States
University of Chicago Medicine
Chicago Illinois, 60637, United States
Indiana University Medical Center
Indianapolis Indiana, 46202, United States
Johns Hopkins University CRB1
Baltimore Maryland, 21287, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Memorial Sloan-Kettering Cancer Center - Memorial hospital
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Baylor college of Medicine
Houston Texas, 77030, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Baylor College - Ucop
Houston Texas, , United States
Fred Hutchison Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
ZNA Middelheim
Antwerpen , , Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
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
Centro Regional Integrado de Oncologia
Fortaleza , 60366, Brazil
Centro de Pesquisas Clinicas em Oncologia
Porto Alegre , 90610, Brazil
Ain Shams University Hospital
Cairo , , Egypt
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
Kifisiá , , Greece
General University Hospital Papageorgiou
Thessaloniki , , Greece
Thermi Clinic
Thessaloniki , , Greece
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
Instituto Nacional De Cancerologia
Mexico , , Mexico
BOOG
Amsterdam , , Netherlands
Instituto De Enfermedades Neoplasicas
Lima , , Peru
Medical University Of Gdansk
Gdansk , , Poland
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw , , Poland
Champalimaud Cancer Center
Lisbon , , Portugal
Instituto Portugues De Oncologia - Centro Do Porto
Porto , , Portugal
Institute of Oncology and Radiology
Belgrade , 11000, Serbia
Hospital General Vall D'Hebron
Barcelona , , Spain
Hospital Universitario 12 De Octubre
Madrid , , Spain
Swedish Association of Breast Oncologists
Göteborg , , Sweden
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
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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT01101425

Recruitment Status:

Active, not recruiting

Sponsor:


European Organisation for Research and Treatment of Cancer - EORTC

How clear is this clinincal trial information?

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