Studieoverzicht - 2013-02 Male BC prospectief

 
Number 2013-02 Male BC prospectief
Nickname Prosp Male BC
Status Follow up Date: 07-12-2017
Inclusion closed
Other study number(s) EORTC 10085
Participating parties/groups EORTC
Full title Male Breast Cancer: prospective into perspective
Phase and type Observational
Age ≥18
Menopausal status Not applicable
Indication Data registration
Subindication Not applicable
Target sample size 270
Actual accrual 270 Date: 01-02-2018
Estimated study completion date 31-12-2017
CCMO approval Not applicable Date: Nr:
EudraCT nr. Not applicable
Trial Register
METC approval Date: METC: Nr:
Amendments No Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website http://www.bigagainstbreastcancer.org/projects/big-02/
Sponsor BOOG Study Center
Principal Investigator(s) C.P. Schröder, J.W.M. Martens, C.J. van Asperen
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization
Monitoring Not applicable
Local datamanagement
Funding Logo Pink Ribbon.jpgFunding by Pink Ribbon
Extra Submitted to METC Groningen dd 19-8-2013 (2013/291) and judged being not applicable to WMO registration

Design:

This nationwide study is a multicentre, prospective, observational and non-interventional study.

Objectives:

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). 

Endpoints:

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.

Main eligibility criteria:

 

- gender: male

- diagnosis: primary invasive breast cancer (all stages of the disease)

- age: over 18 years old at moment of diagnosis

- mental competence and understanding of the Dutch language are required

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