Male Breast Cancer: Understanding the Biology for Improved Patient Care

This study is currently recruiting participants.
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

April 9, 2010
January 20, 2014
December 2010
June 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • Time to locoregional relapse [ Designated as safety issue: No ]
  • Time to second primary [ Designated as safety issue: No ]
  • Time to distant relapse [ Designated as safety issue: No ]
  • Survival and progression-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01101425 on ClinicalTrials.gov Archive Site
Not Provided
  • Patient and disease characteristics [ Designated as safety issue: No ]
  • Patterns of treatment offered to these patients [ Designated as safety issue: No ]
  • Histologic, pathologic, and molecular features of male BC [ Designated as safety issue: No ]
  • Biomarker status with baseline clinicopathologic variables and patient outcome using multivariable analysis [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Male Breast Cancer: Understanding the Biology for Improved Patient Care
Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.

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).

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.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
10 Years
Not Provided
Non-Probability Sample

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.

Breast Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
June 2016   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact: Nicolas Dif, PhD nicolas.dif@eortc.be
Contact: Carlo Messina, MD carlo.messina@eortc.be
United States,   Belgium,   Poland,   United Kingdom
 
NCT01101425
EORTC-10085, BIG 2-07, TBCRC 029
No
European Organisation for Research and Treatment of Cancer - EORTC
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
Study Chair: Fatima Cardoso, MD Champalimaud Cancer Center (Portugal)
Study Chair: Sharon H. Giordano, MD, MPH M.D. Anderson Cancer Center
European Organisation for Research and Treatment of Cancer - EORTC
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP