Clinical trial NCT06518135: Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
Official title: Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer: a Prospective, Multicenter, Single Arm, Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sentinel Lymph Node Biopsy
Keywords: Axillary sentinel lymph node biopsy
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-24
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients with positive initial cT1-3N1 axillary lymph nodes

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients With ECOG Score 0-1 Points
2. Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
3. Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
4. Patients With Effective Neoadjuvant Therapy (CR+PR)
5. Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
6. Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
7. Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
8. Patients Without Obvious Contraindications for Surgery or Radiation Therapy
9. No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
10. Patients Who Participate in Other Clinical Trials at the Same Time and Are Judged by the Researchers Not to Affect the Study Protocol Can be Enrolled Normally
11. The patient voluntarily joined this study and signed an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer；
2. Simultaneous double breast cancer；
3. Baseline cT4;
4. Baseline cN2-3
5. gestation
6. There are contraindications for SLNB;
7. Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study

Primary outcomes:
measure: Axillary recurrence-free survival
timeFrame: 5th year after surgery
Secondary outcomes:
measure: regional lymph node recurrence-free survival
timeFrame: 5th year after surgery
measure: Disease-free survival
timeFrame: 5th year after surgery
measure: Overall survival
timeFrame: 5th year after surgery
measure: The incidence of postoperative upper limb lymphedema
timeFrame: 5th year after surgery
measure: EORTC-QLQ-C30 V3 rating
timeFrame: 5th year after surgery
Other outcomes:
Locations:
city: Henan
country: China
facility: Henan cacer hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Zhenzhen Liu
role: PRINCIPAL_INVESTIGATOR
References: