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Male Breast Cancer: Understanding the Biology for Improved Patient Care

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ClinicalTrials.gov Identifier: NCT01101425
Recruitment Status : Active, not recruiting
First Posted : April 12, 2010
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
Breast International Group
Swiss Group for Clinical Cancer Research
Cancer Trials Ireland
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

Tracking Information
First Submitted Date April 9, 2010
First Posted Date April 12, 2010
Last Update Posted Date September 11, 2017
Study Start Date December 2010
Estimated Primary Completion Date February 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2014)
  • Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. [ Time Frame: end of study ]
  • Patient and disease characteristics. [ Time Frame: end of study ]
  • Patterns of treatment offered to these patients [ Time Frame: end of study ]
  • Biological characterization of the disease [ Time Frame: End of study ]
Original Primary Outcome Measures
 (submitted: April 9, 2010)
  • Survival and progression-free survival
  • Time to locoregional relapse
  • Time to distant relapse
  • Time to second primary
Change History Complete list of historical versions of study NCT01101425 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: April 9, 2010)
  • Patient and disease characteristics
  • Patterns of treatment offered to these patients
  • Histologic, pathologic, and molecular features of male BC
  • Biomarker status with baseline clinicopathologic variables and patient outcome using multivariable analysis
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.

Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: January 20, 2014)
200
Original Estimated Enrollment
 (submitted: April 9, 2010)
1800
Estimated Study Completion Date March 2027
Estimated Primary Completion Date February 2027   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Brazil,   Egypt,   Greece,   Ireland,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   Serbia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01101425
Other Study ID Numbers EORTC-10085
BIG 2-07
TBCRC 029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
  • Breast International Group
  • Swiss Group for Clinical Cancer Research
  • Cancer Trials Ireland
  • 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 (TX, USA)
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2017