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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

• Registration Number: NCT04993625
• Lead Sponsor: Jeong Eon Lee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-06
• Study Start: 2021-09-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 178

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy	avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy	-

Primary Outcome Measures

Name	Time	Method
5-year recurrence free survival	5-year after last patient enrollment	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 Outcome Measures

Name	Time	Method
LRFS	5-year after last patient enrollment	5-year local recurrence-free survival
IBTR	5-year after last patient enrollment	5-year ipsilateral breast tumor recurrence interval
OS	5-year after last patient enrollment	5-year overall survival
toxicity rate	5-year after last patient enrollment	5-year cumulative toxicity rate
Adverse Event	5-year after last patient enrollment	5-year quality of life
CSS	5-year after last patient enrollment	5-year cancer-specific survival
IARI	5-year after last patient enrollment	5-year ipsilateral axillary recurrence interval
EORTC QLQ	5-year after last patient enrollment	5-year quality of life

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of