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 (ASLAN)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy	Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy; Selective Omission 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year recurrence free survival	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.	5-year after last patient enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jeong Eon Lee
• Collaborators: Asan Medical Center; Seoul National University Hospital; Gangnam Severance Hospital; Severance Hospital
• Investigators: Principal Investigator: Jeong Eon Lee, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ASLAN
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: SMC 2021-02-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No