Actively Recruiting
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer: a Prospective, Multicenter, Single Arm, Real World Study
Led by Henan Cancer Hospital · Updated on 2024-12-17
508
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best technical approach and long-term tumor safety of sentinel lymph node biopsy (SLNB) in patients with initial cN1 breast cancer who have undergone neoadjuvant chemotherapy (NAC) and have downgraded to clinical axillary node-negative status (ycN0). Although SLNB is recommended by guidelines, the optimal technique and long-term safety data are still unclear, prompting this real-world study to explore these aspects further. The primary focus is on axillary recurrence-free survival, alongside other important outcomes related to lymph node recurrence, disease-free survival, overall survival, lymphedema incidence, and quality of life. This prospective, multicenter, single-arm study involves patients receiving SLNB after completing NAC and before breast surgery. If the frozen pathology of sentinel lymph nodes (SLNs) is negative, no axillary lymph node dissection (ALND) is performed. If SLNs are positive or the frozen pathology is falsely negative, ALND is recommended, with completion within 12 weeks after SLNB surgery if needed. The study aims to evaluate this optimized pathway and its outcomes in a real-world clinical setting. Participants will be monitored over five years after surgery to assess axillary recurrence-free survival and secondary outcomes such as regional lymph node recurrence, disease-free survival, overall survival, and postoperative upper limb lymphedema. Quality of life will also be evaluated using the EORTC-QLQ-C30 V3 scale. The study involves regular follow-up and assessments to track these outcomes and understand the long-term safety and effectiveness of the SLNB approach in this patient group.
CONDITIONS
Brief 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...
- Patients with ECOG score 0-1 points
- Diagnosed with invasive breast cancer stage cT1-3N1M0 with ipsilateral axillary lymph node metastasis
- Abnormal axillary lymph nodes detected by imaging are 3 or fewer
- Patients with effective neoadjuvant therapy response (complete or partial response)
- Clinical axillary negative status (ycN0) after neoadjuvant therapy
- No prior ipsilateral axillary surgery or radiation therapy
- No previous ipsilateral breast cancer history, including carcinoma in situ
- No obvious contraindications for surgery or radiation therapy
- No other malignancies within 5 years before enrollment
- Patients participating in other clinical trials judged not to affect this study can enroll
- 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 nodal stage cN2-3
- Pregnancy
- Contraindications to sentinel lymph node biopsy
- Serious comorbidities or other conditions interfering with planned treatment or making participation unsuitable according to researcher judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks after neoadjuvant chemotherapy
Participants undergo axillary sentinel lymph node biopsy (SLNB) after completion of neoadjuvant chemotherapy and before breast surgery. If frozen pathology of sentinel lymph nodes is negative, axillary lymph node dissection (ALND) is not performed. If frozen pathology is positive, ALND is performed directly. In cases of false negative frozen pathology, ALND is recommended within 12 weeks after SLNB surgery.
1 surgical visit and additional visits if ALND is needed
Duration - Up to 5 years after surgery
Participants are monitored for axillary recurrence-free survival, regional lymph node recurrence-free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and quality of life.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Henan cacer hospital
Henan, Henan, China, 450008
Actively Recruiting
Research Team
Z
Zhenzhen Liu
M
Minhao Lv
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here