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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy<br> | Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASLAN