Sentinel Node Vs Observation After Axillary Ultra-souND

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Jun 18, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating whether some women with early-stage breast cancer can avoid a specific type of surgery called sentinel lymph node biopsy (SLNB) when their preoperative tests show no signs of cancer in the lymph nodes. The researchers believe that if imaging tests show no issues in the axilla (the area under the arm), patients can have a less invasive treatment without negatively affecting their health outcomes. The goal is to see if skipping this surgery can help patients maintain a better quality of life while still making treatment decisions based on the characteristics of their tumors.

To participate in this study, women must have breast cancer that is smaller than 2 cm and show no signs of cancer in their axilla. They should be eligible for breast-conserving surgery followed by radiation and must agree to participate by signing a consent form. Women who have other serious health conditions, previous cancers, or certain complications related to their breast cancer may not be eligible. If you qualify and choose to join the trial, you can expect to undergo regular follow-ups and be part of a study that aims to improve treatment approaches for breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • breast cancer \<2 cm, and a clinically negative axilla
• • any age
• • candidates to receive breast conserving surgery + radiotherapy
• • negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found)
• • written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
• • patients must be accessible for follow-up.
• Exclusion Criteria:
• • synchronous distant metastases
• • previous malignancy
• • bilateral breast cancer
• • multicentric or multifocal breast cancer
• • previous primary systemic therapy
• • pregnancy or breastfeeding
• • pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
• • pre-operative radiological evidence of multiple involved or suspicious nodes
• • patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.