T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)

Launched by FONDAZIONE HUMANITAS PER LA RICERCA · Dec 2, 2021

Keywords

ClinConnect Summary

The SINODAR ONE trial is studying whether it is safe to skip the removal of certain lymph nodes in women with early-stage breast cancer who have a small number of cancerous sentinel lymph nodes. The main goal is to see if not removing these lymph nodes affects survival or the chance of cancer returning in the same area compared to the standard treatment, which involves removing these lymph nodes. This research is important as it may help reduce surgery for patients while keeping their treatment effective.

Women aged 40 to 75 with specific types of breast cancer might be eligible to participate. To qualify, they should have a tumor size of 50 mm or smaller, no signs that the cancer has spread to other parts of the body, and only up to two positive sentinel lymph nodes. Participants can expect to be randomly assigned to either the experimental treatment or the standard treatment. Additionally, this trial is currently active but not recruiting new participants. It aims to provide valuable insights into a less invasive approach to treating early-stage breast cancer while ensuring patient safety and effective care.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age: 40 ≤75 years old
• • Breast cancer with infiltrating histology
• • Tumor size ≤50 mm (T1 - T2)
• • Clinically and ultrasound node-negative (cN0) breast cancer
• • No distant metastases (M0)
• • No neoadjuvant therapy
• • Negative history of previous infiltrating neoplasm
• • Maximum number of metastatic sentinel lymph nodes: 2
• • Lymph node macro-metastases \> 2mm
• Exclusion Criteria:
• • Pregnancy or breastfeeding in progress
• • Inflammatory breast cancer
• • Breast cancer in situ
• • Synchronous contralateral breast cancer
• • Co-morbidities such as to preclude the possible use of adjuvant therapy
• • Conditions that make it impossible to carry out a regular follow-up
• • Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca)
• • Breast cancer with non-infiltrating or inflammatory histotype
• • Tumor size\> 50 mm
• • No sentinel lymph nodes identified
• • No positive sentinel lymph nodes (pN0)
• • Positive sentinel lymph node number \> 2
• • Lymph node micro-metastases \<= 2