Guided treatment of lymph nodes in breast cancer after chemotherapy
Precise Treatment of Axillary Lymph Nodes After Neoadjuvant Chemotherapy Guided by Long-term Nanocarbon Tracing: a Clinical Cohort Study
This study is testing if using a special dye to guide treatment can help improve the accuracy of lymph node surgery for early breast cancer patients who have had chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Shenyang, Liaoning and 1 other locations) |
| Trial ID | NCT05241119 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using nanocarbon tracing to guide axillary lymph node treatment in patients with early breast cancer who have undergone neoadjuvant chemotherapy. A total of 100 patients diagnosed with stage N2 or N3 breast cancer will be recruited and treated at Liaoning Oncology Hospital. The study will assess the accuracy of sentinel lymph node biopsy (SLNB) following chemotherapy, aiming to reduce the false negative rate associated with conventional methods. Participants will receive ultrasound-guided injections of nanocarbon into the largest metastatic lymph node, followed by surgical evaluation within four weeks after completing chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with invasive breast cancer at stage N2 or N3 who are eligible for neoadjuvant chemotherapy.
Not a fit: Patients with a previous history of breast cancer or other malignant tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of lymph node involvement, potentially improving long-term survival rates for breast cancer patients.
How similar studies have performed: While the use of nanocarbon tracing is a novel approach, other studies have explored similar techniques in lymph node assessment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * invasive breast cancer confirmed by biopsy and histology; * based on prone CT scan and Doppler ultrasound, axillary stage cN2-3; * agree and meet the requirements for NAC; * meet surgical requirements and agree to undergo surgery after NAC; * the regime of NAC follows the NCCN recommendations. Exclusion Criteria: • previous history of breast cancer or other malignant tumors.
Where this trial is running
Shenyang, Liaoning and 1 other locations
- Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (Recruiting)
- Jianyi Li — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Jianyi Jianyi, Master — Cancer Hospital of China Medical University, Liaoning Cancer Hospital
- Study coordinator: Jianyi Li, Master
- Email: sjbreast@yeah.net
- Phone: 8618940257177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.