Male Breast Cancer: Understanding the Biology for Improved Patient Care

Objectives retrospective part (closed to patients registration in September 2013):

- To perform a large international joint retrospective analysis of clinical and
biological data of male breast cancer (BC) patients treated from 1990 to 2010.

- To create a database of patient characteristics, disease features, treatments received,
and clinical outcomes of a large series of men diagnosed with BC from 1990 to 2010 in
centers in Europe and USA.

- To perform a central pathological review of the corresponding large series of male BC
tumors to determine their biologic characteristics and identify relevant prognostic and
predictive markers.

Objectives prospective part (opened early 2014):

- To run a prospective registry of all male BC patients (including newly diagnosed)
irrespective of the stage and treatment, in the participating institutions for a period
of 30 months; collection of FFPE, fresh frozen and blood samples is optional but highly
encouraged.

- Quality of Life sub-study

The two parts of this study will provide important information regarding male BC biology and
clinical evolution. The collected follow-up information will provide an overview of the
current practice in the early and the advanced disease and also offer precious information
of the disease evolution in such rare patients' population.

Retrospective part (closed to patients registration):

- Men with histologically proven invasive breast carcinoma diagnosed since 1990 to
2010.

- A FFPE tissue sample from the primary tumor (e.g. biopsy or surgery) is mandatory

Prospective part:

- All men, with histologically proven invasive breast cancer, newly presenting at the
center irrespective of the stage of disease, initial diagnosis date or treatment
received.

- patients cannot be registered in both the retrospective and protective parts of
the study

- patients who newly present at the center in the 3 months prior to center
activation are still eligible as long as they were not previously included in
the retrospective part of the study

- Before patient registration, written informed consent must be obtained according to
ICH/GCP, and national/local regulations.

- Collection of left-over FFPE and frozen tumor samples as well as blood is optional.

Both parts:

- Concomitant DCIS or LCIS are allowed only if invasive cancer is present.

- Patients should be 18 years or over at the time of diagnosis.

- The study will accept all stages of disease (e.g. early BC, locally advanced and
metastatic disease) independent of the treatment received. Patients with past or
concurrent other malignancies are eligible.