Surgical management of the axilla in primary systemic treatment of breast cancer
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00009793
- Lead Sponsor
- niversitätsfrauenklinik am Klinikum Südstadt
- Brief Summary
Introduction: Clipping and selective removal of initially suspicious axillary lymph nodes in breast cancer patients who have been sonographically down-staged by primary systemic therapy improves the accuracy of surgical staging and provides the opportunity for more conservative axillary surgery. This study evaluated whether preoperative ultrasound-guided wire localization of the clipped node is useful for routine clinical practice. Material and methods: This prospective, single-center feasibility trial included patients with invasive breast cancer (cT1-3N1-3M0) treated by primary systemic therapy. They underwent ultrasound-guided core needle biopsy and clip placement into the most suspicious axillary lymph node prior to chemotherapy. After primary systemic therapy the clipped lymph node was localized by a wire. All patients underwent target lymph node biopsy, completion axillary lymph node dissection and, if yiN0, axillary sentinel lymph node biopsy. The primary study endpoint was the identification rate of the target lymph node. Results: All patients (n = 30) underwent successful clip insertion into the lymph node. After chemotherapy, the clipped target lymph node was visible by ultrasound in 83.3% (25/30). Wire localization was possible in 24 cases (80%), and the clipped node identification rate was 70.8% (17/24 cases). In 9/30 patients (30%) clipped node removal was not confirmed by intraoperative radiography. Conclusion: Ultrasound-guided wire localization of the target lymph node is not suitable for clinical practice because of limitations regarding clip visibility and selective surgical preparation of the target lymph node. Further prospective evaluation of alternative techniques is needed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 30
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
male patients, pregnancy, age <18 years, T4-tumors, distant metastases (M1)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method concordance of primary minimal-invasive histologically proven suspicious axillary, clipmarked lymphnodes and sentinel lymphnodes after primary systemic treatment<br>work measurement: surgery
- Secondary Outcome Measures
Name Time Method -creation of an oncologically safe concept to reduce axillary surgical radicalness after primary sytemic treatment in breast cancer patients with suspicious ipsilateral lymphnodes<br>-rate of detection of axillary sentinel nodes after primary systemic treatment<br>-predicitve value of the clipmarked lymphnode for metastatic disease in further lymphnodes after primary systemic treatment<br>-adverse events caused by clipmarking lymphnodes