Male Breast Cancer: Understanding the Biology for Improved Patient Care

Breast Cancer Clinical Trial

Official title:

Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01101425
• Other study ID #: EORTC-10085
• Secondary ID: BIG 2-07TBCRC 02
• Status: Active, not recruiting
• Start date: December 2010
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Retrospective part (closed to patients registration):

• Men with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Neoplasms, Male

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Belgium	CHU St Pierre	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Cliniques Universitaires St. Luc	Brussels
Belgium	Hopital Universitaire Brugmann	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Hopital De Jolimont	Haine St Paul
Belgium	UZ Leuven	Leuven
Belgium	ZNA Jan Palfijn	Merksem
Belgium	CHU Ucl Namu - Clinique Sainte Elisabeth	Namur
Belgium	AZ Damiaan - Campus Sint-Jozef	Oostende
Brazil	Centro Regional Integrado de Oncologia	Fortaleza
Brazil	Centro de Pesquisas Clinicas em Oncologia	Porto Alegre
Egypt	Ain Shams University Hospital	Cairo
Greece	Alexandra Hospital	Athens
Greece	Aretaieio Hospital	Athens
Greece	General Hospital of Air Force	Athens
Greece	Hippokration General Hospital Of Athens	Athens
Greece	Hygeia Hospital	Athens
Greece	IASO general hospital	Athens
Greece	University General Hospital Heraklion	Heraklion
Greece	Agioi Anargiroi Hospital	Kifisiá
Greece	General University Hospital Papageorgiou	Thessaloniki
Greece	Thermi Clinic	Thessaloniki
Ireland	Cork University Hospital	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordia Hospital	Dublin
Ireland	St. James'S Hospital	Dublin
Ireland	St. Vincent'S Hospital	Dublin
Ireland	Waterford Regional Hospital	Waterford
Mexico	Instituto Nacional De Cancerologia	Mexico
Netherlands	BOOG	Amsterdam
Peru	Instituto De Enfermedades Neoplasicas	Lima
Poland	Medical University Of Gdansk	Gdansk
Poland	Maria Sklodowska-Curie Memorial Cancer Centre	Warsaw
Portugal	Champalimaud Cancer Center	Lisbon
Portugal	Instituto Portugues De Oncologia - Centro Do Porto	Porto
Serbia	Institute of Oncology and Radiology	Belgrade
Spain	Hospital General Vall D'Hebron	Barcelona
Spain	Hospital Universitario 12 De Octubre	Madrid
Sweden	Swedish Association of Breast Oncologists	Göteborg
Switzerland	Kantonsspital Baden	Baden
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Sonnenhofklinik Engeriedspital	Bern
Switzerland	Spitalzentrum Biel	Biel
Switzerland	Kantonales Spital Herisau	Herisau
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Cantonal Hospital Liestal	Liestal
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Ospedale Beata Vergine	Mendrisio
Switzerland	Hopital de Sion	Sion
Switzerland	Kantonsspital St Gallen	St Gallen
Switzerland	ZeTuP St.Gallen	St Gallen
Switzerland	Radio-Onkologie Berner Oberland AG	Thun
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	UniversitaetsSpital Zurich	Zurich
United Kingdom	City Hospital	Birmingham
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	LLandough Hospital	Cardiff
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	Leighton Hospital	Crewe
United Kingdom	Queen Margaret Hospital	Dunfermline
United Kingdom	Eastbourne District General Hospital	Eastbourne
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	New Victoria Hospital	Glasgow
United Kingdom	Crosshouse Hospital	Kilmarnock
United Kingdom	Forth Valley Royal Hospital	Larbert
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Royal Alexandra Hospital	Paisley
United Kingdom	University Hospital of North Tees	Stockton on Tees
United Kingdom	The Great Western Hospital	Swindon
United Kingdom	Wishaw General Hospital	Wishaw
United Kingdom	Worthing Hospital	Worthing	West Sussex
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Johns Hopkins University CRB1	Baltimore	Maryland
United States	University Of Alabama Comprehensive Cancer Cente	Birmingham	Alabama
United States	University Of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago Medicine	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College - Ucop	Houston	Texas
United States	Baylor college of Medicine	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Memorial Sloan-Kettering Cancer Center - Memorial hospital	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UCSF University of California San Francisco Medical Center-Mount Zion	San Francisco	California
United States	Fred Hutchison Seattle Cancer Care Alliance	Seattle	Washington
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (10)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Borstkanker Onderzoek Groep, Breast International Group, Cancer Trials Ireland, Hellenic Cooperative Oncology Group, Hellenic Oncology Research Group, Latin American Cooperative Oncology Group, Swedish Association of Breast Oncologists, Swiss Group for Clinical Cancer Research, Translational Breast Cancer Research Consortium

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Egypt,  Greece,  Ireland,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Serbia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.		end of study
Primary	Patient and disease characteristics.		end of study
Primary	Patterns of treatment offered to these patients		end of study
Primary	Biological characterization of the disease		End of study