Clinically node-negative by physical examination and axillary ultrasound
No neoadjuvant systemic therapy
Not planned to receive whole-breast radiotherapy
Planned for one of the following local treatments:
Cohort 1: Breast-conserving surgery without radiotherapy
Age under 65 years with clinical T1 tumor and biologically low risk, defined as Oncotype DX Recurrence Score 18 or less, OncoFREE Decision Index 15 or less, or Ki-67 13.25% or less with histologic grade 1 or 2
Age 65 years or older with clinical tumor size 3 cm or less and histologic grade 1 or 2
Cohort 2: Breast-conserving surgery with accelerated partial breast irradiation, with clinical T1 tumor and histologic grade 1 or 2
Cohort 3: Mastectomy without radiotherapy, with histologic grade 1 or 2
Written informed consent
You may not be if
Clinically or radiologically suspicious axillary lymph nodes
Prior ipsilateral invasive breast cancer or prior axillary surgery
Bilateral breast cancer
Inflammatory breast cancer
Pregnancy
Any condition that precludes protocol-specified surgery or follow-up
Concurrent participation in another interventional clinical trial that may affect the primary endpoint of this study
Clareo Health | NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy
