Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 200
- Locations
- 122
- Primary Endpoint
- Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.
Study Overview
Brief Summary
Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease.
Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010.
Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Retrospective part (closed to patients registration):
- •Men with histologically proven invasive breast carcinoma diagnosed since 1990 to
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.
Time Frame: end of study
Biological characterization of the disease
Time Frame: End of study
Patient and disease characteristics.
Time Frame: end of study
Patterns of treatment offered to these patients
Time Frame: end of study
Secondary Outcomes
No secondary outcomes reported