Studieoverzicht - 2009-04 Male BC retrospectief

 
Number 2009-04 Male BC retrospectief
Nickname Retrosp Male BC
Status Closed Date: 29-10-2013
Inclusion closed
Other study number(s) EORTC 10085
Participating parties/groups EORTC, BIG, SOLTI, NABCG, SWOG
Full title Clinical and biological characterization of Male Breast Cancer: an international retrospective EORTC, BIG and NABCG intergroup study
Phase and type Observational
Age ≥18
Menopausal status Not applicable
Indication Data registration
Subindication Not applicable
Target sample size 1200
Actual accrual Date:
Estimated study completion date 31-12-2013
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2009-011581-29
Trial Register
METC approval Submitted Date: 25-09-2010 METC: Erasmus Medisch Centrum Rotterdam Nr: statement of no objection
Amendments Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website http://www.bigagainstbreastcancer.org/projects/big-02/
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
Monitoring
Local datamanagement
Funding Logo Pink Ribbon.jpgFunding by Pink Ribbon
Extra

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.
Main 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.
Documents (public):
Documents (protected):
In order to see this content you need to be logged on.

Login.

Back