BOOG Study Center
C.P. Schröder, J.W.M. Martens, C.J. van Asperen
A.E. van Leeuwen-Stok
Not applicable
Funding by Pink Ribbon
Submitted to METC Groningen dd 19-8-2013 (2013/291) and judged being not applicable to WMO registration
This nationwide study is a multicentre, prospective, observational and non-interventional study.
The main objective is to initiate a nationwide, multicenter prospective registry of all male BC patients in order to give insight in the present-day treatment, outcome, side effects and gender related QoL aiming at implementation of this knowledge into treatment guidelines for male BC patients.
Secondary objectives are to evaluate the feasibility of a phase III prospective randomized clinical trial (focusing on specific psychosocial support and life style issues) by analyzing the recruitment of Male BC patients in the Netherlands in this study, to analyze blood and tumor tissue samples in relation to recently developed targeted therapies and treatment strategies aiming at personalized medicine and, finally, to use this registry for comparison with data from female BC patients (in a separate study).
In this observational study, main study parameters will focus on clinical outcomes (survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary), patient and disease characteristics, QoL and patterns of treatment offered to these patients.
