NCT04993625

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
31mo left

Started Sep 2021

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Sep 2021Dec 2028

First Submitted

Initial submission to the registry

July 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

7.3 years

First QC Date

July 7, 2021

Last Update Submit

January 24, 2024

Conditions

Breast Cancer

Keywords

ASLAN

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • LRFS

    5-year after last patient enrollment

  • CSS

    5-year after last patient enrollment

  • OS

    5-year after last patient enrollment

  • IBTR

    5-year after last patient enrollment

  • IARI

    5-year after last patient enrollment

  • +3 more secondary outcomes

Study Arms (1)

Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

EXPERIMENTAL
Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

Interventions

avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapyPROCEDURE

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

Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

Eligibility Criteria

Age20 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤Age\<70
  • undergone neoadjuvant chemotherapy
  • HER-2 or triple negative breast cancer
  • clinical stage T1-3, N0-1, M0 (AJCC 8th)
  • not Inflammatory breast cancer
  • 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
  • undergone anti HER-2 therapy in HER-2 positive patient
  • no preoperative anti hormonal therapy
  • no preoperative radiation therapy
  • did not axillary lymph node biopsy before neoadjuvant chemotherapy
  • physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm
  • no previous axilla surgery
  • +5 more criteria

You may not qualify if:

  • During pregnancy
  • major depression or taking psychiatric medication
  • significant psychiatric disorder or history of taking antipsychotic drugs
  • any other lymph node metastasis than axillary lesion
  • undergoing total mastectomy
  • do not agree to the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Ryu 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: 38685868DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeong Eon Lee, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Samsung Medical Center

Study Record Dates

First Submitted

July 7, 2021

First Posted

August 6, 2021

Study Start

September 27, 2021

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)