Trial document




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  DRKS00009793

Trial Description

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Title

Surgical management of the axilla in primary systemic treatment of breast cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

primary endpoint:
concordance of primary minimal-invasive histologically proven suspicious axillary, clipmarked lymphnodes and sentinel lymphnodes after primary systemic treatment
secondary endpoint:
-creation of an oncologically safe concept to reduce axillary surgical radicalness after primary sytemic treatment in breast cancer patients with suspicious ipsilateral lymphnodes
-rate of detection of axillary sentinel nodes after primary systemic treatment
-predicitve value of the clipmarked lymphnode for metastatic disease in further lymphnodes after primary systemic treatment
-adverse events caused by clipmarking lymphnodes

After infromed consent the suspicious axillary lymphnode will be marked by a clip (HYDROMARK). The surgical procedure after primary systemic treatment depends on axillary response:
-iN+/pN0 before chemotherapy --> axillary SLNB and exstirpation of clipped lymph node, fresh frozen section, in case of metastatic lymph node complete axillary lymph node dissection
-pN+ before chemotherapy -->yiN0 --> axillary SLNB and exstirpation of clipped lymph node, fresh frozen section, in case of metastatic lymph node complete axillary lymph node dissection
-pN+ before chemotherapy --> yiN+ --> exstirpation of clipped lymph node and complete axillary lymph node dissection

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Organizational Data

  •   DRKS00009793
  •   2015/12/18
  •   [---]*
  •   yes
  •   Approved
  •   A 2015-0160, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Before starting primary chemotherapy suspicious axillary lymphnodes will be marked by a clip (HYDROMARK)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

concordance of primary minimal-invasive histologically proven suspicious axillary, clipmarked lymphnodes and sentinel lymphnodes after primary systemic treatment
work measurement: surgery

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Secondary Outcome

-creation of an oncologically safe concept to reduce axillary surgical radicalness after primary sytemic treatment in breast cancer patients with suspicious ipsilateral lymphnodes
-rate of detection of axillary sentinel nodes after primary systemic treatment
-predicitve value of the clipmarked lymphnode for metastatic disease in further lymphnodes after primary systemic treatment
-adverse events caused by clipmarking lymphnodes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/01/04
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

all patients diagnosed with invasive breast cancer (c/iT1-3, uni- or bilateral) at the university of rostock, who receive a primary systemic treatment and present with clinically/sonographically suspicious ipsilateral axillary lymphnodes (c/iN+) without distant metastases

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Exclusion Criteria

male patients, pregnancy, age <18 years, T4-tumors, distant metastases (M1)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik am Klinikum Südstadt
    • Ms.  Dr. med.  Steffi  Hartmann 
    • Südring 81
    • 18059  Rostock
    • Germany
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    • Universitätsfrauenklinik am Klinikum Südstadt
    • Ms.  Dr. med.  Steffi  Hartmann 
    • Südring 81
    • 18059  Rostock
    • Germany
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    • Universitätsfrauenklinik am Klinikum Südstadt
    • Ms.  Dr. med.  Steffi  Hartmann 
    • Südring 81
    • 18059  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsfrauenklinik am Klinikum Südstadt
    • Südring 81
    • 18059  Rostock
    • Germany
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    •   0381/44014500
    •   0381/44014599
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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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.