Target axillary dissection after chemotherapy for locally advanced breast cancer
Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
This study is testing if a new surgery method for removing lymph nodes after chemotherapy can help people with locally advanced breast cancer have better outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (L'Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Trial ID | NCT05763641 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the effectiveness of target axillary dissection (TAD) in patients with locally advanced breast cancer who have undergone neoadjuvant chemotherapy. The procedure involves marking a pathological lymph node with a clip before chemotherapy and performing surgery afterward to excise the marked node and sentinel nodes. The study will analyze the false negative rate of the procedure by initially evaluating 30 cases and continuing until 81 cases are collected if necessary. This approach seeks to improve surgical outcomes and lymph node assessment in breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with clinically or radiologically confirmed axillary lymph node metastasis and extensive T4 tumors undergoing neoadjuvant chemotherapy.
Not a fit: Patients with cN3 verified by imaging tests, those with luminal A subtype tumors, or those undergoing neoadjuvant endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical precision and reduce the false negative rate in lymph node assessments for breast cancer patients.
How similar studies have performed: While this approach is being validated in this specific context, similar methodologies have shown promise in other studies focusing on lymph node management in breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Axillary lymph node metastasis proven by cytology * Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis) * Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria * Neoadjuvant chemotherapy Exclusion Criteria: * cN3 verified by imaging tests * N2 due to internal mammary involvement (N2b). * Tumors whose surrogate molecular subtype is luminal A. * Patients undergoing neoadjuvant endocrine therapy * Patients with local recurrences and metastatic tumors.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona and 1 other locations
- Hospital de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Clínico y Provincial de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: amparo Garcia-Tejedor, MDPhD — Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
- Study coordinator: Amparo García-Tejedor, MDPhD
- Email: agarciat@bellvitgehospital.cat
- Phone: 0034-932607702
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.