Target axillary dissection after chemotherapy for locally advanced breast cancer
Official title: Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Run by Hospital Universitari de Bellvitge · NCT05763641 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 162 (estimated) |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (L'Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2021 |
| Main results expected | December 1, 2026 |
| Study ends | June 1, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT05763641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with clinically or radiologically confirmed axillary lymph node metastasis and extensive T4 tumors undergoing neoadjuvant chemotherapy.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using indocyanine green to find sentinel lymph nodes during mastectomy
This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.
-
Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery
This project tests whether indocyanine green dye and a fluorescence camera can be used instead of the radioactive tracer to find sentinel lymph nodes in adults having breast cancer surgery who are clinically node-negative.
-
Using advanced imaging technology for early-stage breast cancer surgery
This study is testing a new imaging tool during breast cancer surgery to see if it can help doctors find lymph nodes more accurately and improve treatment for patients.
-
New imaging technology for identifying breast cancer and lymph node status
This study is testing a new imaging technology to help doctors better identify breast cancer and check lymph nodes during surgery for patients with breast cancer.
-
Tailoring axillary surgery for breast cancer patients
This study is testing if some early breast cancer patients can skip certain surgeries to remove lymph nodes, which might help them avoid unnecessary complications and costs.
-
Using a low dose of Magtrace to locate lymph nodes in breast cancer patients
This study is testing if a low dose of a new tracer can help find lymph nodes in breast cancer patients as well as the traditional methods do.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.