Selective Image-Guided Surgery in Determining Accuracy of Metastatic Lymph Node Removal in Patients with Breast Cancer

Inclusion Criteria

• Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum three abnormal axillary nodes on ultrasound exam) M0
• Core needle biopsy (or fine needle aspiration [FNA]) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy or surgery; clinical care marker clip placed in the one or two abnormal axillary nodes identified at ultrasound at the time of core needle or FNA of an axillary node that documented nodal disease
• Subjects must be undergoing neoadjuvant systemic therapy (including cytotoxic, endocrine and/or immunotherapy) (or have just completed it) prior to the surgical intervention
• No prior axillary lymph node surgery for pathological confirmation of axillary status
• No nitinol (nickel-titanium) allergy; the Savi Scout marker device contains nitinol
• Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to receipt of chemotherapy; NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
• Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 30 days after chemotherapy discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria

• Active infection requiring systemic therapy
• Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer
• Any distant metastasis by imaging and biopsy (cM1)
• Patients not having neoadjuvant systemic therapy