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NCT04993625: ASLAN
Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy In HER-2 Positive/Triple Negative Breast Cancer Patients With Excellent Radiologic Response to the Breast and Axilla, Prospective, Multi-center, Single-arm (ASLAN) Study
NA trial testing avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy in Breast Cancer in 178 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2028
Quick facts
| Lead sponsor | Jeong Eon Lee |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 178 |
| Start date | 27 September 2021 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Jeong Eon Lee
Who can join
Adults 20 to 69, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial.
Jung JJ, Cheun JH, Kim SY, Koh J, et al · · 2024 · cited 19× · PMID 38433091 · DOI 10.4048/jbc.2023.0265 -
Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response.
Ryu JM, Lee H, Han W, Lee HB, et al · · 2024 · cited 7× · PMID 38685868 · DOI 10.4048/jbc.2023.0264 -
Locoregional Therapy: From Mastectomy to Reconstruction, Targeted Surgery, and Ultra-Hypofractionated Radiotherapy.
Banys-Paluchowski M, Hartmann S, Ditsch N, Krawczyk N, et al · · 2023 · cited 2× · PMID 38130814 · DOI 10.1159/000533748 -
A Survey of Practice Patterns for Clinical Nodal Staging Prior to Neoadjuvant Chemotherapy in Breast Cancer.
Lee HB, Lee KH, Song SH, Kim K, et al · · 2023 · cited 1× · PMID 37279777 · DOI 10.1093/oncolo/oyad156 -
Omission of Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: Expanding Evidence in Clinically Node-Negative and Neoadjuvant Therapy Responders.
Grapes A, Young J, Takabe K. · · 2026 · PMID 42147263 · DOI 10.14740/wjon2776 -
Axillary Surgery in Breast Cancer: Evidence-Based De-escalation Across Upfront and Post-Neoadjuvant Settings.
Park WK, Nam SJ, Kim SW, Yu J, et al · · 2026 · PMID 41612659 · DOI 10.4048/jbc.2025.0290 -
A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer.
Jung JJ, Kim HJ, Chae BJ, Kim EK, et al · · 2025 · PMID 41311332 · DOI 10.4048/jbc.2025.0157
Verify or expand the search:
- PubMed search for NCT04993625
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jeong Eon Lee trials
Trials by the same sponsor.
- NCT07245316 — Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine · NA · not yet recruiting
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 NCT04993625 (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 Jeong Eon Lee
- Last refreshed: 26 January 2024
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/NCT04993625.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing