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SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies. The main endpoint of the study was axillary recurrence free survival. The secondary study endpoints were regional lymph node recurrence free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLNB group | Standard sentinel lymph node biopsy group, if frozen pathology SLNs are negative, no ALND will be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If the frozen pathology is false negative, it is recommended to complete ALND within 12 weeks after SLNB surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLNB group | Other | After the completion of neoadjuvant therapy, axillary SLNB should be performed first before breast surgery; If the frozen pathology SLNs are negative, ALND will no longer be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If frozen pathology is false negative. |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary recurrence-free survival | The time from surgery to axillary recurrence or last follow-up | 5th year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| regional lymph node recurrence-free survival | The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up | 5th year after surgery |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients with positive initial cT1-3N1 axillary lymph nodes
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenzhen Liu | Contact | 0371-65587005 | liuzhenzhen73@126.com | |
| Minhao Lv | Contact | 0371-65587406 |
| Name | Affiliation | Role |
|---|---|---|
| Zhenzhen Liu | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan cacer hospital | Recruiting | Henan | Henan | 450008 | China |
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The time from surgery to the occurrence of recurrence, metastasis, or last follow-up
| 5th year after surgery |
| Overall survival | The time from surgery to patient death or last follow-up | 5th year after surgery |
| The incidence of postoperative upper limb lymphedema | By using the circumference method, the styloid process of the ulna is taken as the starting point, with an interval of 10cm and measured up to 40cm. The circumference is measured, and the volume of the affected limb is ≥ 10% or>200ml. | 5th year after surgery |
| EORTC-QLQ-C30 V3 rating | The EORTC-QLQ-C30 V3 is the core scale of the quality of life measurement system developed by the European Organization for Research and Treatment of Cancer (EORTC) for cancer patients. The scale consists of 30 items, including 5 functional scales (physical function, role function, cognitive function, emotional function, social function), 3 symptom scales (fatigue, pain, malignant vomiting), 6 individual measurement items (swallowing difficulties, loss of appetite, sleep disorders, constipation, diarrhea, economic difficulties), and 1 patient self-assessment item (overall health status). The original scores for each item need to be converted into standardized scores ranging from 0 to 100 using a linear formula. The higher the score for each functional dimension, the better the functional status; The higher the score of the symptom scale and individual items, the more obvious the symptoms and the poorer the quality of life. | 5th year after surgery |