Male Breast Cancer: Understanding the Biology for Improved Patient Care
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).
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||10 Years|
|Official Title:||Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.|
- Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. [ Time Frame: end of study ] [ Designated as safety issue: No ]
- Patient and disease characteristics. [ Time Frame: end of study ] [ Designated as safety issue: No ]
- Patterns of treatment offered to these patients [ Time Frame: end of study ] [ Designated as safety issue: No ]
- Biological characterization of the disease [ Time Frame: End of study ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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:
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101425
|Contact: Nicolas Dif, PhDfirstname.lastname@example.org|
|Contact: Carlo Messina, MDemail@example.com|
|United States, Texas|
|Md Anderson Cancer Center||Recruiting|
|Houston, Texas, United States|
|United States, Washington|
|Fred Hutchison Seattle Cancer Care Alliance||Recruiting|
|Seattle, Washington, United States|
|Cliniques Universitaires St. Luc||Recruiting|
|Hopital Universitaire Brugmann||Recruiting|
|Institut Jules Bordet||Recruiting|
|Contact: Lissandra Dal lago firstname.lastname@example.org|
|Principal Investigator: Lissandra Dal lago|
|Universitair Ziekenhuis Antwerpen||Recruiting|
|Hopital De Jolimont||Recruiting|
|Haine St Paul, Belgium|
|AZ Groeninghe - Campus Loofstraat||Recruiting|
|ZNA Jan Palfijn||Recruiting|
|Clinique Sainte Elisabeth||Recruiting|
|AZ Damiaan - Campus Sint-Jozef||Recruiting|
|Medical University Of Gdansk||Recruiting|
|Worthing, West Sussex, United Kingdom|
|Royal Sussex County Hospital||Recruiting|
|Brighton, United Kingdom|
|Cheltenham General Hospital||Recruiting|
|Cheltenham, United Kingdom|
|Eastbourne District General Hospital||Recruiting|
|Eastbourne, United Kingdom|
|NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, United Kingdom|
|University Hospital of North Tees||Recruiting|
|Stockton on Tees, United Kingdom|
|Study Chair:||Fatima Cardoso, MD||Champalimaud Cancer Center (Portugal)|
|Study Chair:||Sharon H. Giordano, MD, MPH||M.D. Anderson Cancer Center|