Last reviewed · How we verify
NCT05160324: SINODAR ONE
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)
NA trial testing Removal of axillary lymph nodes. in Breast Cancer in 889 participants. Status unknown.
30 April 2025
Quick facts
| Lead sponsor | Fondazione Humanitas per la Ricerca |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 889 |
| Start date | 14 April 2015 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 April 2025 |
Drugs / interventions tested
- Removal of axillary lymph nodes.
- Preservation of axillary lymph nodes
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Fondazione Humanitas per la Ricerca
Who can join
Adults 40 to 75, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Tinterri C, Canavese G, Gatzemeier W, Barbieri E, et al · · 2023 · cited 46× · PMID 37471574 · DOI 10.1093/bjs/znad215 -
Oncologic safety of breast-conserving surgery in node-positive breast cancer: a systematic review and meta-analysis.
Sun J, Lin S. · · 2026 · PMID 41668907 · DOI 10.21037/gs-2025-406
Verify or expand the search:
- PubMed search for NCT05160324
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05160324 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Humanitas per la Ricerca
- Last refreshed: 5 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05160324.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing