Primary Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with Sentinel node procedure (RISAS) following neoadjuvant chemotherapy (NAC): a novel surgical approach to accurately assess axillary response to neoadjuvant systemic therapy, thereby reducing future need for completion axillary lymph node dissection and subsequent morbidity
Completed
- Conditions
- 10006295lymph node metastasis10006291
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 248
Inclusion Criteria
1. Female patient with pathologically confirmed axillary lymph node positive
invasive primary breast cancer, treated with neoadjuvant chemotherapy
2. Willing and able to undergo all study procedures
3. Has personally provided written informed consent
Exclusion Criteria
1. Age < 18
2. Pregnancy or lactation
3. Contra indication for undergoing SLNB, such as allergic reaction on 99m
Technetium or patent blue.
4. Recurrent breast cancer
5. Previous axillary surgery or radiotherapy, (e.g. Hodgkin disease treatment)
6. Patients with periclavicular lymph node metastases (cN3)
7. Patients with advanced breast cancer (i.e. patients with distant metastases,
treated without any further surgical procedures)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main goal of this study is to examine the accuracy (identification rate,<br /><br>sensitivity, NPV and FNR) of the RISAS procedure to identify axillary pCR,<br /><br>compared to the current axillary surgical procedure ALND. The pathologic<br /><br>examination of the ALND is the gold standard for nodal involvement and staging.<br /><br><br /><br>If the RISAS procedure is accurate in the evaluation of axillary pCR, this can<br /><br>result in reducing an ALND in these patients, thereby reducing the risk of<br /><br>developing potential morbidity of axillary surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study is to examine the accuracy<br /><br>(identification rate, sensitivity, NPV and FNR) of both techniques used in<br /><br>RISAS separately (i.e. SLNB and MARI), compared to ALND. Again, the pathologic<br /><br>examination of the ALND will be regarded as the gold standard for nodal<br /><br>involvement and staging.<br /><br><br /><br>Subgroup analyses might demonstrate that the use of a single technique is<br /><br>sufficiently accurate to identify axillary pCR in certain subgroups, indicating<br /><br>these patients only require either SLNB or MARI.</p><br>