Clinical trial · Interventional
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2
- 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)
Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omission of Axillary dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1: experimental
- description
- patients with micro metastatic sentinel lymph node and/or parasentinella lymph node (ypN1mi). Axillary dissection is not performed.
- interventionNames
- Procedure: Omission of Axillary dissection
- type
- ACTIVE_COMPARATOR
- label
- Group 2: standard
- description
- patients with negative sentinel lymph node (ypN0) or with ITC finding (ypN0 / YpN0 (i +)). Axillary dissection is not performed as standard treatment.
- interventionNames
- Procedure: Omission of Axillary dissection
Primary outcomes (1)
- measure
- Disease-free or death-free survival for any reason (DFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18 ≤75 years 2. Breast carcinoma with infiltrating histotype 3. Tumor size: cT1 - cT2 - cT3 4. Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation 5. Neoadjuvant chemotherapy performed 6. Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment 7. Absence of distant metastases (M0) 8. Negative medical history for previous infiltrating breast cancer Exclusion Criteria: 1. Current pregnancy or lactation status 2. Inflammatory breast cancer 3. In situ breast cancer 4. Synchronous contralateral breast cancer 5. Co-morbidity and/or medical disorder precluding any adjuvant therapy 6. Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up 7. Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
References
Publications (0)
Data not yet available