Clinical trial · Interventional
RISAS Procedure in Node Positive Breast Cancer Following NAC
Primary Radioactive Iodine Seed Localisation in the Axilla in Axillary Node Positive Breast Cancer Combined With Sentinel Node Procedure (RISAS) Following Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chemotherapy in clinically node positive breast cancer patients is increasingly administrated in a neoadjuvant setting. The standard treatment regimen in these cases is then: neoadjuvant chemotherapy (NAC) followed by breast surgery and an axillary lymph node dissection (ALND). NAC results in axillary pathologic complete response (pCR) in 1 out of 3 patients, indicating a complete absence of axillary metastases after completion of NAC. In such events, ALND can be regarded as overtreatment that creates unnecessary morbidity. Less invasive axillary surgery which can accurately assess axillary pCR is therefore preferred over standard ALND in all patients. In case of detection of remaining axillary lymph node metastases by this less invasive axillary surgical procedure, completion axillary treatment is standard of care. The novel RISAS procedure is introduced as a possible less invasive axillary staging procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure. The iodine seed in the axillary lymph node metastasis will be placed prior to start of NAC.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Lymph Nodes | — | UNRESOLVED | — |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Pathological Complete Response | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RISAS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RISAS
- description
- All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.
- interventionNames
- Procedure: RISAS
Primary outcomes (1)
- measure
- Identification rate and accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of RISAS-procedure for identifying axillary pCR, with 95% confidence intervals will be calculated.
- timeFrame
- Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.
Secondary outcomes (1)
- measure
- The identification rate and accuracy (sensitivity, NPV and FNR) of both techniques used in RISAS-procedure (i.e. SLNB and MARI) for identifying axillary pCR, will be calculated separately as well.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patient with pathologically confirmed axillary lymph node positive invasive primary breast cancer, treated with neoadjuvant chemotherapy * Willing and able to undergo all study procedures. * Has personally provided written informed consent. Exclusion Criteria: * Age \< 18 * Pregnancy or lactation * Contra indications for undergoing iodine seed placement or sentinel lymph node biopsy, such as allergic reaction on iodine, 99m Technetium or patent blue. * Recurrent breast cancer * Previous axillary surgery or radiotherapy * Patients with periclavicular lymph node metastases (cN3) * Patients with advanced breast cancer (i.e. patients with distant metastases, treated without any furter surgical procedures)
References
Publications (2)
- BACKGROUNDvan Nijnatten TJA, Simons JM, Smidt ML, van der Pol CC, van Diest PJ, Jager A, van Klaveren D, Kam BLR, Lobbes MBI, de Boer M, Verhoef K, Koppert LB, Luiten EJT. A Novel Less-invasive Approach for Axillary Staging After Neoadjuvant Chemotherapy in Patients With Axillary Node-positive Breast Cancer by Combining Radioactive Iodine Seed Localization in the Axilla With the Sentinel Node Procedure (RISAS): A Dutch Prospective Multicenter Validation Study. Clin Breast Cancer. 2017 Aug;17(5):399-402. doi: 10.1016/j.clbc.2017.04.006. Epub 2017 Apr 19. PMID 28487053
- DERIVEDvan Amstel FJG, de Mooij CM, Simons JM, Mitea C, van Diest PJ, Nelemans PJ, van der Pol CC, Luiten EJT, Koppert LB, Smidt ML, van Nijnatten TJA; REFINE Study Group. Disease extent according to baseline [18F]fluorodeoxyglucose PET/CT and molecular subtype: prediction of axillary treatment response after neoadjuvant systemic therapy for breast cancer. Br J Surg. 2024 Aug 30;111(9):znae203. doi: 10.1093/bjs/znae203. PMID 39302345