# RISAS — Protocolo del Ensayo Prospectivo Multicéntrico Holandés (MARI + SLNB combinados)

**Autores:** van Nijnatten TJA, Simons JM, Smidt ML, van der Pol CC, van Diest PJ, Jager A, et al. (consorcio holandés MUMC+/UMC Utrecht/Erasmus/Amphia)
**Revista:** Clinical Breast Cancer (2017)
**PMID:** 28487053 | **PMCID:** —
**DOI:** [10.1016/j.clbc.2017.04.006](https://doi.org/10.1016/j.clbc.2017.04.006)
**Fuente:** PubMed (abstract only — full text vía DOI/institución)
**Trial registration:** NCT02800317

## Relevancia ⭐ PIVOTAL
Protocolo del **RISAS trial** que valida la combinación **MARI + SLNB** (Radioactive Iodine Seed in Axilla + Sentinel) en 225 pacientes cN+ post-NAC, con ALND de confirmación. Define el procedimiento estándar holandés para staging axilar minimamente invasivo. Resultados finales publicados en 2022 (Simons et al.).

## Abstract

**Background:** In 1 of 3 patients with initial lymph node-positive (cN+) breast cancer, neoadjuvant chemotherapy (NAC) results in an axillary pathologic complete response (ax-pCR). This urges the need for a less-invasive axillary staging method. Recently introduced less-invasive procedures have been insufficient in accurately identifying ax-pCR. Therefore, we propose a novel less-invasive axillary staging procedure: **the Radioactive Iodine Seed localization in the Axilla with the Sentinel node procedure (RISAS)**, a combination of MARI and sentinel lymph node biopsy (SLNB).

**Methods:** In the present open single-arm multicenter validation study, **225 cN+ (biopsy-proven) patients** will undergo the RISAS procedure, in which a positive lymph node is marked by an iodine-125 seed before NAC. After NAC completion, this seed-marked lymph node is removed, together with any additional sentinel lymph nodes. The RISAS procedure is subsequently followed by completion ALND. The RISAS lymph nodes will be compared with the lymph nodes from the completion ALND specimen. **Primary endpoint:** accuracy of RISAS. IR, FNR, NPV and concordance MARI vs SLNB are reported.

**Conclusion:** The present prospective multicenter RISAS trial will enable us to validate the combination of MARI and SLNB for assessing the axillary response to NAC in cN+ patients. If RISAS proves to be an accurate axillary staging procedure, **ALND could safely be abandoned in the case of ax-pCR confirmed using the RISAS procedure**.

## Acceso
Artículo no disponible en PMC. Acceder vía [DOI](https://doi.org/10.1016/j.clbc.2017.04.006) o suscripción institucional.

---
*Datos de PubMed. Citar: doi 10.1016/j.clbc.2017.04.006*
