Actively Recruiting
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
Led by Henan Cancer Hospital · Updated on 2024-12-17
508
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status of 0 to 1
- Breast cancer stage cT1-3N1M0 with invasive breast cancer and ipsilateral axillary lymph node metastasis
- Abnormal axillary lymph nodes detected by imaging, no more than 3
- Effective response to neoadjuvant therapy (complete or partial response)
- Clinical axillary node-negative status (ycN0) after neoadjuvant therapy
- No prior surgery or radiation therapy on the ipsilateral axilla
- No previous history of ipsilateral breast cancer, including carcinoma in situ
- No obvious contraindications for surgery or radiation therapy
- No other history of malignant tumors within 5 years before enrollment
- Participation in other clinical trials allowed if not affecting this study protocol
- Voluntary participation with signed informed consent
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Simultaneous double breast cancer
- Baseline tumor stage cT4
- Baseline lymph node stage cN2-3
- Pregnancy
- Contraindications for sentinel lymph node biopsy
- Serious comorbidities or other conditions that interfere with planned treatment or make the patient unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan cacer hospital
Henan, Henan, China, 450008
Actively Recruiting
Research Team
Z
Zhenzhen Liu
CONTACT
M
Minhao Lv
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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