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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Severance Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Asan Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy | Procedure | 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 |
| 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 |
| 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 |
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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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Eon Lee, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38685868 | Derived | 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. |
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| OTHER |
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|
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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