Clinical trial · Interventional
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
Selective Avoidanve 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 Study
- 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)
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.
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 |
|---|---|---|---|
| avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
- interventionNames
- Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
Primary outcomes (1)
- measure
- 5-year recurrence free survival
- timeFrame
- 5-year after last patient enrollment
- 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 expected complete remission.
Secondary outcomes (8)
- measure
- LRFS
- timeFrame
- 5-year after last patient enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion criteria 1. 20≤Age\<70 2. undergone neoadjuvant chemotherapy 3. HER-2 or triple negative breast cancer 4. clinical stage T1-3, N0-1, M0 (AJCC 8th) 5. not Inflammatory breast cancer 6. neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed) * least four times anthacycline or taxane-based regimens * no axilla lesion progression during chemotherapy * no period of adverse response during chemotherapy 7. undergone anti HER-2 therapy in HER-2 positive patient 8. no preoperative anti hormonal therapy 9. no preoperative radiation therapy 10. did not axillary lymph node biopsy before neoadjuvant chemotherapy 11. physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm 12. no previous axilla surgery 13. no previous ipsilateral breast surgery for invasive cancer 14. no Pregnancy-associated breast cancer 15. ECOG performance status 0-1 16. Serum or urine b-HCG negative 17. agree to the consent form Exclusion criteria 1. During pregnancy 2. major depression or taking psychiatric medication 3. significant psychiatric disorder or history of taking antipsychotic drugs 4. any other lymph node metastasis than axillary lesion 5. undergoing total mastectomy 6. do not agree to the consent form
References
Publications (1)
- DERIVEDRyu JM, Lee H, Han W, Lee HB, Ahn SG, Kim HJ, Park HS, Choi JS, Kim H, Cho WK, Lee JE. 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. J Breast Cancer. 2024 Apr;27(2):130-140. doi: 10.4048/jbc.2023.0264. PMID 38685868