Male Breast Cancer: Understanding the Biology for Improved Patient Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborators:
Breast International Group
the North American Breast Cancer Group
Swiss Group for Clinical Cancer Research
ICORG- All Ireland Cooperative Oncology Research Group
Borstkanker Onderzoek Groep
Swedish Association of Breast Oncologists
Hellenic Cooperative Oncology Group
Hellenic Oncology Research Group
Latin American Cooperative Oncology Group
Translational Breast Cancer Research Consortium
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01101425
First received: April 9, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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
Breast Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • 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 ]
  • Biological characterization of the disease [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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:

  • 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101425

Contacts
Contact: Nicolas Dif, PhD nicolas.dif@eortc.be
Contact: Carlo Messina, MD carlo.messina@eortc.be

Locations
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
Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium
Cliniques Universitaires St. Luc Recruiting
Brussels, Belgium
Hopital Universitaire Brugmann Recruiting
Brussels, Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium
Contact: Lissandra Dal lago       lissandra.dallago@bordet.be   
Principal Investigator: Lissandra Dal lago         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium
Hopital De Jolimont Recruiting
Haine St Paul, Belgium
AZ Groeninghe - Campus Loofstraat Recruiting
Kortrijk, Belgium
ZNA Jan Palfijn Recruiting
Merksem, Belgium
Clinique Sainte Elisabeth Recruiting
Namur, Belgium
AZ Damiaan - Campus Sint-Jozef Recruiting
Oostende, Belgium
Poland
Medical University Of Gdansk Recruiting
Gdansk, Poland
United Kingdom
Worthing Hospital 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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Breast International Group
the North American Breast Cancer Group
Swiss Group for Clinical Cancer Research
ICORG- All Ireland Cooperative Oncology Research Group
Borstkanker Onderzoek Groep
Swedish Association of Breast Oncologists
Hellenic Cooperative Oncology Group
Hellenic Oncology Research Group
Latin American Cooperative Oncology Group
Translational Breast Cancer Research Consortium
Investigators
Study Chair: Fatima Cardoso, MD Champalimaud Cancer Center (Portugal)
Study Chair: Sharon H. Giordano, MD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01101425     History of Changes
Other Study ID Numbers: EORTC-10085, BIG 2-07, TBCRC 029
Study First Received: April 9, 2010
Last Updated: January 20, 2014
Health Authority: Belgium: Ethics Committee
United Kingdom: Research Ethics Committee
Portugal: Health Ethic Committee
Spain: Ethics Committee
Poland: Ethics Committee

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
male
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014