Clinical and biological characterization of Male Breast Cancer: an international retrospective EORTC, BIG and NABCG intergroup study
Indication
Data registration
Subindication
Not applicable
Target sample size
1200
Estimated study completion date
31/12/2013
Contact
Sponsor
EORTC, BOOG
Principal Investigator(s)
F. Cardoso (EORTC), C.P. Schröder, J. Martens, C van Asperen (BOOG)
Study manager
A.E. van Leeuwen-Stok, N.H. Dijkstra
Central datamanagement and randomization
BOOG Study Center Postbus 9236 1006 AE Amsterdam tel 020 346 2547 fax 020 346 2597 email info@boogstudycenter.nl
Funding
Funding by Pink Ribbon
Design
Retrospective dataregistration
Objectives
To perform a large international joint retrospective analysis of clinical and biological data of male BC patients treated in the last 20 years. To create a database of patient characteristics, disease features, treatments received and clinical outcomes of a large series of men diagnosed with BC over the last 20 years in centers in Europe, America and third countries. To perform a central pathological review of the correspondent large series of male BC tumors to determine their biological characteristics and identify relevant prognostic and predictive markers. This study will provide important information regarding male BC and set the scene for a second phase which is a prospective, international, multicenter, registry of male BC with concomitant material collection which will enable us to decide if a clinical trial could be launched for male BC patients.
Endpoints
Primary enpoint:
Clinical outcomes
Survival
Progression free survival
Time to locoregional relaps
Time to distant relaps
Time to second primary.
Patient and disease characteristics.
Patterns of treatment offered to this patient.
Eligibility Criteria
Males with histologically proven invasive breast carcinoma diagnosed since 1990 to date. Concomitant DCIS or LCIS are allowed if invasive cancer is present. A FFPE tissue sample from primary tumor (e.g. biopsy or surgery) is mandatory for enrollment of the patient and must be available for central pathology review. The availability of fresh frozen samples is optional. The study will accept all stages of disease (e.g. early BC, locally advanced and metastatic disease) independent of the treatment received.