Prospective, randomized, controlled, multicenter, operative study to evaluate the role of intraoperative sonography compared to the preoperative wire localization in the treatment of non-palpable breast cancer

Not Applicable

Recruiting

Conditions: C50
Malignant neoplasm of breast

Registration Number: DRKS00010174

Lead Sponsor: niversitätsfrauenklinik

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 230

Inclusion Criteria

written consent after verbal clarification by an
Study physician for this study is available
- Histologically proven invasive breast cancer
- Non-palpable tumor
- Indication for BEI
- CT1b-cT2
- Female patient> 18 years
- Sonographically detectable tumor in two levels
- Karnofsky Performance Status - Index =70% or ECOG <2

Exclusion Criteria

- Multifocal tumor
- Recurrence of breast cancer
- Tumor <5mm
- Inability to understand the meaning and purpose of the clinical trial or the comply with conditions for studying

OP capability not available

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of R0 resections, ie the rate of histologically safe in healthy distant breast cancer, with a safety margin of 1mm, at BEI after wire localization vs. BEI after intraoperative US, with the objective of demonstrating non-inferiority of the intraoperative ultrasound with respect to the wire marking.

Secondary Outcome Measures

Name	Time	Method
Secondary study objectives:<br>- Comparison of the rate of intraoperative resections under two localization methods<br>- Comparison of the rate of second operations under both localization methods<br>- Comparison of the remote resection volume in both arms<br>- Cosmetic Results<br>- Operation time<br>- Determining an optimum ultrasound distance between the tumor and the resection margin in order to achieve a minimal histological safety margin of 1mm<br>- Evaluation of the measured tumor size in breast ultrasound, mammography and possibly in MR mammography compared to pathologically measured tumor size<br>- Determination of characteristics of tumor biology, which are associated with an extensive intraductal component.