Clinical trial · Interventional
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes in the Presence of Sentinel Lymph Node Metastases (SINODAR ONE)
- 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 two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preservation of axillary lymph nodes | Procedure | — | UNRESOLVED |
| Removal of axillary lymph nodes. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Axillary dissection (standard treatment)
- description
- Axillary dissection in women with sentinel lymph node metastases. (removal of at least 10 lymph nodes recommended)
- interventionNames
- Procedure: Removal of axillary lymph nodes.
- type
- EXPERIMENTAL
- label
- Preservation of axillary lymph nodes
- description
- Omission of Axillary dissection in women with sentinel lymph node metastases.
- interventionNames
- Procedure: Preservation of axillary lymph nodes
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 40 ≤75 years old * Breast cancer with infiltrating histology * Tumor size ≤50 mm (T1 - T2) * Clinically and ultrasound node-negative (cN0) breast cancer * No distant metastases (M0) * No neoadjuvant therapy * Negative history of previous infiltrating neoplasm * Maximum number of metastatic sentinel lymph nodes: 2 * Lymph node macro-metastases \> 2mm Exclusion Criteria: * Pregnancy or breastfeeding in progress * Inflammatory breast cancer * Breast cancer in situ * Synchronous contralateral breast cancer * Co-morbidities such as to preclude the possible use of adjuvant therapy * Conditions that make it impossible to carry out a regular follow-up * Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca) * Breast cancer with non-infiltrating or inflammatory histotype * Tumor size\> 50 mm * No sentinel lymph nodes identified * No positive sentinel lymph nodes (pN0) * Positive sentinel lymph node number \> 2 * Lymph node micro-metastases \<= 2
References
Publications (1)
- DERIVEDTinterri C, Canavese G, Gatzemeier W, Barbieri E, Bottini A, Sagona A, Caraceni G, Testori A, Di Maria Grimaldi S, Dani C, Boni L, Bruzzi P, Fernandes B, Scorsetti M, Zambelli A, Gentile D; SINODAR-ONE Collaborative Group. Sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer patients undergoing mastectomy with one to two metastatic sentinel lymph nodes: sub-analysis of the SINODAR-ONE multicentre randomized clinical trial and reopening of enrolment. Br J Surg. 2023 Aug 11;110(9):1143-1152. doi: 10.1093/bjs/znad215. PMID 37471574