Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy

Launched by THE NETHERLANDS CANCER INSTITUTE · Jan 8, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at whether some women with breast cancer can skip a specific procedure called sentinel lymph node biopsy (SLNB) after receiving chemotherapy. The study focuses on women with certain types of breast cancer known as HER2-positive or triple-negative breast cancer. Researchers want to find out if it is safe to avoid SLNB if a woman’s MRI shows that her cancer has completely responded to the chemotherapy. By not doing this procedure, the hope is to reduce unnecessary surgeries and complications for patients.

To participate in this trial, women must be at least 18 years old and have been diagnosed with invasive HER2-positive or triple-negative breast cancer. They should have received at least three cycles of chemotherapy and have a tumor that meets specific size criteria. Before starting chemotherapy, they should not have any suspicious lymph nodes, and their MRI must show no signs of cancer after treatment. Women with certain other conditions, like advanced-stage tumors or a history of breast cancer in the same breast, are not eligible. If chosen for the study, participants will be closely monitored throughout the process to ensure their safety and the effectiveness of omitting the biopsy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women, aged ≥ 18 years
• • Invasive HER2+ (HR+/-) or TN breast cancer
• • Primary tumor (T), clinical stage T1-3
• • Neoadjuvant systemic therapy (NST), at least 3 cycles
• • Tumor stage assessed with breast MRI before start NST
• • Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
• • MRI after or during NST shows radiologic complete response
• • Written and signed informed consent
• Exclusion Criteria:
• • Primary tumor (T) clinical stage T4
• • Patients without ultrasound or FDG-PET/CT pre-NST
• • History of breast cancer ipsilateral breast
• • Synchronous contralateral breast cancer
• • Synchronous M1 disease