Retrosp Male BC

BOOG 2009-04

General Information

BOOG number

BOOG 2009-04

Nickname

Retrosp Male BC

Status

Date: 29/10/2013

Participating parties / group

EORTC, BIG, SOLTI, NABCG, SWOG

Other study number

EORTC 10085

Full title

Clinical and biological characterization of Male Breast Cancer: an international retrospective EORTC, BIG and NABCG intergroup study

Indication

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.

Regulatory Information

CCMO approval

Yes

EC approval

Submitted
Date: 25/09/2010
Nr:statement of no objection

EC

Erasmus Medisch Centrum Rotterdam

EudraCT number

2009-011581-29

Downloads

Inloggen