Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma

Launched by INSTITUT CANCEROLOGIE DE L'OUEST · Aug 10, 2018

Keywords

ClinConnect Summary

GANEA3 is a prospective multicenter diagnostic study assessing the benefit of targeting initial involved node in complement to SLND and breast tumor characteristics to predict axillary status after NAC.

The diagnostic performances of this strategy will be primarily assessed by the decrease of the FNR with the combined strategy compared to SLND alone.

The primary objective is to evaluate the interest of identifying, before NAC, the initial involved lymph node to improve the prediction of axillary status after NAC.

The main secondary objectives are :

* To assess the feasibility, at the ti...

Gender

FEMALE

Eligibility criteria

• 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