PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

PRIMARY OBJECTIVES: I. Study fludeoxyglucose [18F]
2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine (FMAU) (fluorine F 18-clevudine
) in 10 patients with known breast cancer to obtain data on safety, circulating metabolite,
tumor imaging feasibility, and radiation dosimetry. II. Assess the potential utility of
FMAU-PET in the imaging evaluation of chemotherapeutic response in 15 patients with breast
cancer. OUTLINE: Patients receive fluorine F18-clevudine intravenously (IV) over 1 minute and
then undergo PET/CT scan at baseline. Patients with human epidermal growth factor receptor 2
positive (HER2+) breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks
after the first course of treatment and after completion of treatment. After completion of
study treatment, patients are followed up at 24 hours.

Inclusion Criteria:

- Inclusion criteria for Aim 1:

- Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard
care

- Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic
resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week
prior to 18-F FMAU

Inclusion criteria for Aim 2:

- Have been diagnosed with a HER2+ invasive cancer of the breast

- Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part
of standard care

- Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to
the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU

Exclusion Criteria:

- Have undergone chemotherapy or radiation therapy within the previous one month

- Women of childbearing potential, unless they have had a negative urine human chorionic
gonadotropin (HCG) within the previous 24 hours of the procedure

- Patients who have had surgery at the site of the suspected lesion within 1 month