# Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial

**Autores:** Jana de Boniface, Jan Frisell, Yvette Andersson et al.
**Revista:** BMC Cancer (2017)
**PMID:** 28549453 | **PMCID:** PMC5446737
**DOI:** [10.1186/s12885-017-3361-y](https://doi.org/10.1186/s12885-017-3361-y)
**Fuente:** PubMed Central (open access full-text)

## Relevancia
Protocolo del ensayo SENOMAC — randomizado para evaluar la no inferioridad de omitir ALND en cN0 con 1-2 macrometástasis en SLNB. Incluye pacientes con tumores T1-T3, mastectomía y NAC previo. Aunque diseñado en cN0, sus resultados son extrapolables al manejo postoperatorio de la enfermedad ganglionar residual y forman parte del paisaje de de-escalación quirúrgica.

## Abstract
The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference.

The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1:1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years.

Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.

NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015.

## Texto completo
Texto completo disponible en PMC: [PMC5446737](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5446737/). Protocolo del ensayo SENOMAC. Aunque el objetivo primario es cN0 con SLNB positivo (macrometástasis 1-2), el diseño incluye explícitamente pacientes con NAC previo y tumores T1-T3, contribuyendo a la evidencia de de-escalación quirúrgica en escenarios más amplios. Tamaño meta 3500 pacientes, endpoint primario BCSS a 5 años. Es la cobertura del lado complementario al escenario cN+→ypN0: qué hacer con enfermedad residual mínima en SLNB.

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*Datos de PubMed. Citar: doi 10.1186/s12885-017-3361-y*
