NCT06518135 Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
| NCT ID | NCT06518135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henan Cancer Hospital |
| Condition | Sentinel Lymph Node Biopsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 508 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 508 participants in total. It began in 2024-04-30 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Zhenzhen Liu
PRINCIPAL INVESTIGATOR
Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT06518135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Sentinel Lymph Node Biopsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06518135 currently recruiting?
Yes, NCT06518135 is actively recruiting participants. Contact the research team at liuzhenzhen73@126.com for enrollment information.
Where is the NCT06518135 trial being conducted?
This trial is being conducted at Henan, China.
Who is sponsoring the NCT06518135 clinical trial?
NCT06518135 is sponsored by Henan Cancer Hospital. The principal investigator is Zhenzhen Liu at Henan Cancer Hospital. The trial plans to enroll 508 participants.