Study of Patients With Male Breast Cancer Treated Within the Past 20 Years
RATIONALE: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial will study medical charts and tumor samples from patients with male breast cancer treated within the past 20 years.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Clinical and Biological Characterization of Male Breast Cancer: An International Retrospective EORTC, BIG 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 ]
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- To perform a large international joint retrospective analysis of clinical and biological data of male breast cancer (BC) patients treated in the last 20 years.
- To create a database of patient characteristics, disease features, treatments received, and clinical outcomes of a large series of men diagnosed with BC over the last 20 years in centers in Europe, America, and third countries.
- 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.
- Provide important information regarding male BC and set the scene for a second phase that is a prospective, international, multicenter, registry of male BC with concomitant material collection that will enable us to decide if a clinical trial is feasible for male BC patients.
- To characterize the histologic, pathologic, and molecular features of male BC.
- To correlate biomarker status with baseline clinicopathologic variables and patient outcome using multivariable analysis.
- To perform IHC for quantitative ER and PgR protein levels, HER-2 status and Ki-67, using FISH when applicable.
- To construct tissue microarrays derived from the formalin-fixed, paraffin-embedded tissue specimens.
- To analyze potential biomarkers which either have previously been reported to correlate with outcome in male BC or are suspected of being of interest in this disease, such as (but not limited to) androgen receptor, cyclin D1, p21, p27, intratumoral aromatase and survivin.
- To perform from the available fresh frozen tumor samples, detailed biologic characterization of male BC using techniques such as enzyme-linked immunosorbent assay to evaluate uPA-PAI1 and AIB1, the prognostic value of the 70-gene profile and the wound signature.
- To evaluate by gene expression profiling technology the presence and relative incidence of the BC biologic subtypes (basal-like, Luminal A and B, HER-2 positive) as well as the presence and clinical significance of "intrinsic" subtype performed by PAM 50 assay.
- To identify and select biomarkers that should be incorporated in the prospective study.
OUTLINE: This is a multicenter study. Patients are stratified according to disease extent (metastatic vs non-metastatic).
Patient charts will be reviewed and data entered into a database. Data will be collected on patient epidemiology (e.g., age, ethnicity), possible risk factors (e.g., family history of cancer, chronic liver disease, obesity), and tumor characteristics (e.g., pathologic size, lymph node involvement, stage of disease, tumor grade, ER and PgR status, HER2 over-expression and results of BRCA 1 and 2 testing). Information regarding surgical therapy, radiotherapy, chemotherapy, and endocrine therapy will be collected. Patient outcomes, (e.g., disease recurrence or progression, new primary cancer, and overall survival) will be noted.
Tumor blocks must be collected and sent to central laboratories in United States (US samples) and in United Kingdom (Europe and the rest of the world samples) for central pathology assessment of several biomarkers in formalin-fixed, paraffin-embedded tissue. Fresh frozen tumor samples, when available, will be requested and analyzed in laboratories in Netherlands and US.
|Contact: Nicolas Dif, PhDfirstname.lastname@example.org|
|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 email@example.com|
|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|