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).
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.
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.
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There are 17 Locations for this study
Birmingham Alabama, 35294, United States
Birmingham Alabama, 35294, United States
San Francisco California, 94115, United States
Washington District of Columbia, 20007, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Baltimore Maryland, 21287, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, , United States
Seattle Washington, 98109, United States
Antwerpen , , Belgium
Brussels , 1200, Belgium
Brussels , , Belgium
Brussels , , Belgium
Brussels , , Belgium
Brussels , , Belgium
Edegem , , Belgium
Haine St Paul , , Belgium
Leuven , , Belgium
Merksem , , Belgium
Namur , , Belgium
Oostende , , Belgium
Fortaleza , 60366, Brazil
Porto Alegre , 90610, Brazil
Cairo , , Egypt
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Heraklion , , Greece
Kifisiá , , Greece
Thessaloniki , , Greece
Thessaloniki , , Greece
Cork , , Ireland
Dublin , , Ireland
Dublin , , Ireland
Dublin , , Ireland
Dublin , , Ireland
Waterford , , Ireland
Mexico , , Mexico
Amsterdam , , Netherlands
Lima , , Peru
Gdansk , , Poland
Warsaw , , Poland
Lisbon , , Portugal
Porto , , Portugal
Belgrade , 11000, Serbia
Barcelona , , Spain
Madrid , , Spain
Göteborg , , Sweden
Baden , , Switzerland
Basel , , Switzerland
Bern , , Switzerland
Bern , , Switzerland
Biel , , Switzerland
Herisau , , Switzerland
Lausanne , , Switzerland
Liestal , , Switzerland
Luzern , , Switzerland
Mendrisio , , Switzerland
Sion , , Switzerland
St Gallen , , Switzerland
St Gallen , , Switzerland
Thun , , Switzerland
Winterthur , , Switzerland
Zurich , , Switzerland
Worthing West Sussex, , United Kingdom
Birmingham , , United Kingdom
Brighton , , United Kingdom
Cardiff , , United Kingdom
Cheltenham , , United Kingdom
Crewe , , United Kingdom
Dunfermline , , United Kingdom
Eastbourne , , United Kingdom
Edinburgh , , United Kingdom
Glasgow , , United Kingdom
Glasgow , , United Kingdom
Kilmarnock , , United Kingdom
Larbert , , United Kingdom
Liverpool , , United Kingdom
Paisley , , United Kingdom
Stockton on Tees , , United Kingdom
Swindon , , United Kingdom
Wishaw , , United Kingdom
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