ASICS trial: Avoiding Sentinel lymph node biopsy In select Clinical node negative breast cancer patients after neoadjuvant Systemic therapy
- Conditions
- Breast cancer1000629110006295
- Registration Number
- NL-OMON48085
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 340
• Women, aged >= 18 years
• Invasive HER2-positive (Hormone receptor +/-) or triple negative breast cancer
• Primary tumor (T), clinical stage T1-3
• Neoadjuvant systemic therapy (NST), at least 3 cycles
• Tumor stage assessed with breast MRI before start NST
• Clinically node negative before start NST (no suspect axillary lymph nodes on
ultrasound and
FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
• MRI after or during NST shows radiologic complete response
• Written and signed informed consent
• Primary tumor (T) clinical stage T4
• Patients without ultrasound or FDG-PET/CT pre-NST
• History of breast cancer ipsilateral breast
• Synchronous contralateral breast cancer
• Synchronous metastatic disease
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is axillary recurrence after 5 years. Previous data<br /><br>indicate a 5-year axillary recurrence rate of 1-3% in cN0 patients who<br /><br>underwent NST. An upper margin of 5% axillary recurrences is considered an<br /><br>acceptable extent of clinical non-inferiority.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are quality of life (specifically axillary morbidity and<br /><br>level of cancer worry), recurrence free survival (RFS), distant metastasis-free<br /><br>survival, disease-specific survival and overall survival.</p><br>