Trial document





This trial has been registered retrospectively.
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  DRKS00009536

Trial Description

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Title

Male breast cancer -
A prospective registry study
the University Women's Hospital Magdeburg in cooperation with the
GBG (German Breast Group)
the diagnosis and treatment of breast cancer man

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Breast cancer in male is very rare, but the observations in recent years showed an increase. For this particular case, there are no standardized guidelines for diagnosis and therapy. This study aims to assess the current register diagnostic and therapeutic approach in more detail.
In the study, tumor samples are collected for further studies too.
To learn more about the compatibility of applied treatments and the course of the disease out, all collected data will be centrally collected anonymously.
Data acquisition is multicentric in Germany and is to be at least 5 years.

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Brief Summary in Scientific Language

The man's breast cancer is, with an estimated European prevalence of 1 per 100,000, a rare tumor disease represents. This is associated with a poor uniform data situation regarding the diagnosis and treatment. The clinical management of this disease is still based on the results generated by the research of breast cancer in women.
The purpose of this registry study is the detection of extensive data on history, diagnosis, pathology, therapy and course of the disease. These data will be the basis for the development of therapeutic concepts. Furthermore, the register study should be a prerequisite for the development of clinical trials, because only from the knowledge of "the current situation" can be meaningful clinical trials design.

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Organizational Data

  •   DRKS00009536
  •   2015/10/30
  •   [---]*
  •   yes
  •   Approved
  •   114/09, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1175-5881 
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Health Condition or Problem studied

  •   C50.9 -  Malignant neoplasm: Breast, unspecified
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Interventions/Observational Groups

  •   The documentation of the data history, diagnosis, pathology, therapy and follow-up is made by the physician in charge of the participating institutions. The completed case report forms are sent to the study office at the University Women's Hospital.

    The following data are collected:

    1. Patient data:
    - Signed agreement clarifying including for tumor removal.
    - Date of diagnosis, surgical data,
    - Data on radiation, chemotherapy, endocrine therapy, immunotherapy

    2.Tumor data: localization, histology, TNM, histology, grading, ER / PR receptor cerb-2 receptor, FISH, information resection margin, R classification, max. tumor diameter

    3. nodal status: total number of positive lymph nodes, the total number of lymph nodes examined,
    Total number of infected sentinel lymph nodes, the total number of examined sentinel nodes
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome


> Prospective recognition of the primary cases of breast cancer in men with the determination of recurrence-free survival

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Secondary Outcome


> Determination of overall survival
> Stage and biological characteristics of breast cancer
> Validation of therapeutic modalities (medications, CHT, Op-type radiation)
> Sensitivity of diagnosis (clinical examination, ultrasound, mammography)
> Determining histopathological factors on tumor tissue

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/09/09
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patient with histologically confirmed, primary breast cancer
- Written consent of the patient for data collection and for the histopathological provisions on tumor tissue.
- Inclusion of patients can only up to the beginning of chemotherapy
- If no chemotherapy must be given, inclusion within 6 months is possible after surgery

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Exclusion Criteria

no

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik
    • Mr.  Prof. Dr. med. Dr. med. h.c.  Serban Dan  Costa 
    • Gerhart-Hauptmann-Str. 35
    • 39108  Magdeburg
    • Germany
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    • GBG Forschungs GmbH
    • Mr.  Prof. Dr. med.  Gunter  von Minckwitz 
    • Martin-Behaim-Str. 12
    • 63263  Neu-Isenburg
    • Germany
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    • Universitätsfrauenklinik
    • Mr.  OA Dr. med.  Holm  Eggemann 
    • Gerhart-Hauptmann-Str. 35
    • 39108  Magdeburg
    • Germany
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    • Universitätsfrauenklinik
    • Ms.  Sabrina  Rudolph 
    • Gerhart-Hauptmann-Str. 35
    • 39108  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Warburg - Melchior - Olearius Stiftung
    • Ferdinandstr. 75
    • 20095  Hamburg
    • Germany
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    •   040-32820
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.