Male Breast Cancer: Understanding the Biology for Improved Patient Care
|ClinicalTrials.gov Identifier: NCT01101425|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2010
Last Update Posted : September 11, 2017
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).
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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.|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||February 2027|
|Estimated Study Completion Date :||March 2027|
- Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. [ 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 ]
- Biological characterization of the disease [ Time Frame: End of study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101425
Show 93 Study Locations
|Study Chair:||Fatima Cardoso, MD||Champalimaud Cancer Center (Portugal)|
|Study Chair:||Sharon H. Giordano, MD, MPH||M. D. Anderson Cancer Center (TX, USA)|