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Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy
Sponsor: The Netherlands Cancer Institute
Summary
This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy
Official title: Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2020-01
Completion Date
2027-07
Last Updated
2020-01-13
Healthy Volunteers
No
Interventions
Omission of sentinel lymph node biopsy
No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible.