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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

Active, enrolled NA Last updated 26 January 2024
What this trial tests

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.

Timeline
27 September 2021
Primary endpoint
31 December 2028
31 December 2028

Quick facts

Lead sponsorJeong Eon Lee
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment178
Start date27 September 2021
Primary completion31 December 2028
Estimated completion31 December 2028
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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

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Other recruiting trials for Breast Cancer

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Data sources for this page

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.

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