Clinical trial · Interventional
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.
Conditions
Conditions (5)
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 Dissection | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Radiotherapy | Radiation | — | UNRESOLVED |
| Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Axillary radiotherapy without lymphadenectomy
- description
- Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
- interventionNames
- Radiation: Axillary Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Axillary lymph node dissection
- description
- Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
- interventionNames
- Procedure: Lymphadenectomy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment * Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs * Post-CT axillary response by ultrasound or MRI * Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment. Exclusion Criteria: * cN2 * ypN0 * History of breast surgery for ipsilateral cancer in the last 10 years * History of other cancer in the last 5 years, except squamous carcinoma of the skin.
References
Publications (1)
- DERIVEDGarcia-Tejedor A, Ortega-Exposito C, Salinas S, Luzardo-Gonzalez A, Falo C, Martinez-Perez E, Perez-Montero H, Soler-Monso MT, Bajen MT, Benitez A, Ortega R, Petit A, Guma A, Campos M, Pla MJ, Pernas S, Penafiel J, Yeste C, Gil-Gil M, Guedea F, Ponce J, Laplana M. Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT trial). Front Oncol. 2023 Aug 9;13:1184021. doi: 10.3389/fonc.2023.1184021. eCollection 2023. PMID 37621686