Clinical trial · Interventional
Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sentinel lymph node dissection (SLND) after NAC, aimed to reduce the rate of unnecessary axillary lymphadenectomy, is not a standard of care in case of patient with previously involved node before NAC because of a too high false negative rate (FNR). Clinical consequences of FNR of SLND after NAC are currently unknown. Consequently, contrary to adjuvant setting, a risk of SLND false negative case after NAC is not acceptable. GANEA3 aims to evaluate the results of an innovative multiparametric strategy combining (1) an identification before chemotherapy of a lymph node involvement using a metal clip and then its analysis after treatment, (2) the analysis of sentinel lymph node (SLN) after NAC, and (3) analysis of biological parameters of breast tumor before and after NAC, to predict axillary status after NAC. This will identify patients with initial lymph node involvement who could benefit from SLN after NAC without additional axillary dissection with a very low FNR (≤1%). The most "pathological" metastatic lymph node will be identified with a metal clip under ultrasound. They will then receive a NAC before breast and axillary surgery. An assessment of the NAC response at the breast and axillary will be performed by imagery. Then, all patients undergo the resection of the tagged axillary node with the metal clip, SLN detection and biopsy and a complementary axillary lymphadenectomy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Metastases | — | UNRESOLVED | — |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tagged axillary metastatic node | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tagged axillary metastatic node
- description
- Patients undergo axillary sonography assessment routinely performed to seek suspicious nodes. A cytological examination (biopsy is optional) of the suspicious node is performed. The involved node is then tagged with a metal clip under sonography. Then, patients receive NAC before surgery. Breast surgery (conservative or radical) and axillary surgery are performed during the same procedure, 4 to 6 weeks after completion of NAC.
- interventionNames
- Procedure: Tagged axillary metastatic node
Primary outcomes (1)
- measure
- False negative rate
- timeFrame
- 30 days after surgery
- description
- number of cases of false prediction of absence of lymph node involvement to the total number of cases with metastatic lymph node. The rate of FN will be calculated for the involved lymph node tagged with the metal clip, the sentinel node, and the both
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥ 18 years old 2. Initial diagnosis of operable invasive breast carcinoma 3. Histologically proven axillary metastasis (cytology or biopsy) before NAC 4. Patient included in a therapeutic approach of neoadjuvant chemotherapy 5. Procedure for the detection of sentinel lymph node by isotopic method +/- colorimetric 6. Information of the patient and obtaining written consent, signed by the patient and the investigator 7. Affiliated patient or beneficiary of the social security Exclusion Criteria: 1. pT4d (inflammatory breast cancer) 2. Metastatic breast cancer 3. Any prior chemotherapy for contralateral breast cancer 4. Local relapse of breast cancer 5. Axillary metastasis not histologically proven before NAC 6. Allergy known to the 2 detection products (Blue and radioactive tracer) 7. Pregnant or lactating woman 8. Neo Adjuvant chemotherapy contraindicated 9. Patient protected or under guardianship or unable to give consent 10. Impossibility of submitting to the medical examination for geographical, social or psychological
References
Publications (1)
- DERIVEDDitsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593. PMID 31833973