Clinical trial NCT01101425: Male Breast Cancer: Understanding the Biology for Improved Patient Care
Official title: Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: male
breast cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Breast International Group
name: Swiss Group for Clinical Cancer Research
name: Cancer Trials Ireland
name: Borstkanker Onderzoek Groep
name: Swedish Association of Breast Oncologists
name: Hellenic Cooperative Oncology Group
name: Hellenic Oncology Research Group
name: Latin American Cooperative Oncology Group
name: Translational Breast Cancer Research Consortium
First posted: 2010-04-12
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective part: males with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.

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.

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.

Eligibility criteria: 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.

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