Male Breast Cancer: Understanding the Biology for Improved Patient Care
- Conditions
- Breast Cancer
- Registration Number
- NCT01101425
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. end of study Biological characterization of the disease End of study Patient and disease characteristics. end of study Patterns of treatment offered to these patients end of study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (93)
University Of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University Of Alabama Comprehensive Cancer Cente
🇺🇸Birmingham, Alabama, United States
UCSF University of California San Francisco Medical Center-Mount Zion
🇺🇸San Francisco, California, United States
Georgetown Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University CRB1
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Scroll for more (83 remaining)University Of Alabama Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States