Evaluating axillary management after chemotherapy for breast cancer
Axillary Management After Neoadjuvant Chemotherapy: May Axillary Biopsy Replace Sentinel Lymph Node Biopsy?
This study is testing if a less invasive lymph node biopsy method can safely be used in women with locally advanced breast cancer after they have had chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Medipol University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (İstanbul, Bagcilar and 1 other locations) |
| Trial ID | NCT06096545 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of sentinel lymph node biopsy (SLNB) in women with locally advanced breast cancer who have undergone neoadjuvant chemotherapy. The study aims to determine if less invasive techniques can be safely used in patients with proven axillary lymph node metastasis. Participants will be randomized into two groups based on the biopsy method used prior to surgery, and their outcomes will be assessed to evaluate the predictability of SLNB. The trial is conducted at two centers in Istanbul, focusing on improving surgical approaches for breast cancer management.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18-65 with clinical stage T1-3 and biopsy-proven N1 breast cancer who have received neoadjuvant chemotherapy.
Not a fit: Patients with a history of axillary surgery, inflammatory breast cancer, or distant metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive surgical options for women with breast cancer, reducing complications and recovery time.
How similar studies have performed: Previous studies have shown promise in using less invasive techniques for axillary management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years-old female patients * Clinical stage T1-3 and biopsy-proven N1 breast cancer * Axillary nodal involvement * Volunteer to participate in to study Exclusion Criteria: * A history of axillary surgery or SLNB, prior axillary excisional lymph node surgery, * N2-3 disease with a decision for initial axillary lymph node dissection (ALND), * Diagnosis of inflammatory breast cancer, * Presence of distant metastasis * Incomplete chemotherapy, pregnancy, and lactation * T4 tumors * Refusal to participate in to study
Where this trial is running
İstanbul, Bagcilar and 1 other locations
- Istanbul Medipol University Hospital — İstanbul, Bagcilar, Turkey (Recruiting)
- Istanbul Gaziosmanpasa Training and Research Hospital — İstanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Pelin Basim, As. prof, MD — Medipol University / General Surgery Department
- Study coordinator: Pelin Basim, As. prof, MD
- Email: pelinakbaba@gmail.com
- Phone: +905337186679
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.