Targeted axillary dissection for breast cancer after chemotherapy
Feasability Study of a New Technique of Axillary Evaluation in Patients With Node Positive Breast Cancer Following Neo-adjuvant Chemotherapy
Universitair Ziekenhuis Brussel · NCT05071911
This study is testing if a new surgery method that targets specific lymph nodes can help breast cancer patients who have had chemotherapy and still have cancer in their lymph nodes, while causing less harm than traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jette, Brussel) |
| Trial ID | NCT05071911 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of targeted axillary dissection (TAD) in breast cancer patients who have undergone neoadjuvant chemotherapy (NAC) and have confirmed axillary lymph node metastasis. The study aims to determine if TAD can reduce surgical morbidity by focusing on lymph nodes that still show metastasis after treatment, as many patients achieve a complete pathological response. By placing a clip in the affected lymph node at diagnosis, the researchers will assess the outcomes of this targeted approach compared to traditional axillary lymph node dissection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with cT1-3N1M0 breast cancer who are eligible for neoadjuvant chemotherapy.
Not a fit: Patients with advanced disease (cN2-3), previous axillary surgery, or those with certain medical conditions such as pregnancy or a pacemaker may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical complications for breast cancer patients while maintaining effective cancer management.
How similar studies have performed: While the approach of targeted axillary dissection is innovative, similar studies have shown promising results in reducing morbidity in breast cancer surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with cT1-3N1M0 breast cancer, histopathologically confirmed. * Age greater than or equal to 18 years and less than or equal to 85 years. * Necessity and agreement to neoadjuvant chemotherapy Exclusion Criteria: * Previous surgery ipsilateral axillary or radiation ipsilateral axillary / chest. * Extranodal metastases M1 * cN2-3 status * Breast cancer with direct invasion of chest wall and / or skin cT4 * Disease progression (clinical /radiological) under neoadjuvant treatment * Pregnancy * Presence of a pacemaker in the ipsilateral chest wall
Where this trial is running
Jette, Brussel
- Universitair Ziekenhuis Brussel — Jette, Brussel, Belgium (RECRUITING)
Study contacts
- Study coordinator: Ine Luyten, MD
- Email: ine.luyten@uzbrussel.be
- Phone: +32 2 477 9398
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.
Conditions: Breast Cancer