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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, Prospective, Multi-center, Single-arm studyTrial (ASLAN)

Primary Purpose

Breast Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
Sponsored by
Jeong Eon Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring ASLAN

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2021
Last Updated
October 13, 2022
Sponsor
Jeong Eon Lee
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1. Study Identification

Unique Protocol Identification Number
NCT04993625
Brief Title
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, Prospective, Multi-center, Single-arm studyTrial
Acronym
ASLAN
Official Title
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, Prospective, Multi-center, Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeong Eon Lee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ASLAN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
5-year recurrence free survival
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.
Time Frame
5-year after last patient enrollment
Secondary Outcome Measure Information:
Title
LRFS
Description
5-year local recurrence-free survival
Time Frame
5-year after last patient enrollment
Title
CSS
Description
5-year cancer-specific survival
Time Frame
5-year after last patient enrollment
Title
OS
Description
5-year overall survival
Time Frame
5-year after last patient enrollment
Title
IBTR
Description
5-year ipsilateral breast tumor recurrence interval
Time Frame
5-year after last patient enrollment
Title
IARI
Description
5-year ipsilateral axillary recurrence interval
Time Frame
5-year after last patient enrollment
Title
toxicity rate
Description
5-year cumulative toxicity rate
Time Frame
5-year after last patient enrollment
Title
EORTC QLQ
Description
5-year quality of life
Time Frame
5-year after last patient enrollment
Title
Adverse Event
Description
5-year quality of life
Time Frame
5-year after last patient enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 20≤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 no previous ipsilateral breast surgery for invasive cancer no Pregnancy-associated breast cancer ECOG performance status 0-1 Serum or urine b-HCG negative agree to the consent form Exclusion criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Eon Lee, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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, Prospective, Multi-center, Single-arm studyTrial

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