A Clinical Trial Evaluating the Safety and Clinical Activity of Radioiodide (131I-) as a Novel Targeted Therapy for Metastatic Breast Cancer That Overexpresses Functional Na/I Symporter

Inclusion Criteria

• •Histologically confirmed breast cancer with clinical and/or radiological evidence of measurable or evaluable metastatic disease by Response Evaluation in Solid Tumors (RECIST) 1.1.
• •Life expectancy ≥12 weeks.
• •Radiologic or clinical evidence of disease progression on prior hormonal and/or chemotherapy
• •There is no restriction on the number of prior lines of therapy.
• •Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2.
• •Full recovery to Grade ≤ 2 from any prior side effects of prior therapy for cancer including radiation therapy, chemotherapy, and/or immunotherapy.
• •Adequate bone marrow function defined as white blood cells (WBCs) ≥ 3.0 × 109/L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L.
• •Adequate renal function defined as serum creatinine \< 1.5 mg/dL or creatinine clearance (GFR) \> 40 mL/min calculated using the following formula: GFR = 175 x Serum Cr-1.154 x age-0.203 x 0.742 (female) and x 1.212 (if patient is African American).
• •Adequate liver function defined as AST, ALT ≤ 3 × upper limit of normal (UNL) in the absence of liver metastasis and ≤ 5 × UNL with liver metastases; bilirubin \< 1.5 × UNL; alkaline phosphatase ≤ 2.5 × UNL in the absence of liver metastasis and \< 5 × UNL in case of bone metastases.
• •TSH, T3 and free T4 must be within normal range.
• •The patient should not have had intravenous or intrathecal iodinated contrast agents (IVP, CT with contrast, myelogram, angiogram) for 4 weeks prior to screening to their 124I- PET/CT scans and/or 131I- treatment.
• •Normal urine or serum Beta-HCG in premenopausal women of childbearing potential
• •Women of childbearing potential must agree to use effective contraception during the treatment period and for at least 6 months after the last dose of 124I- and/or 131I- as these agents interfere with radioactive iodide uptake
• •Signed informed consent.