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

University of Southern California12 enrolled

Overview

This phase I trial studies the side effects of positron emission tomography (PET)/computed tomography (CT) in evaluating response to chemotherapy in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

HER2-positive Breast Cancer Recurrent Breast Cancer

Interventions

laboratory biomarker analysisOTHER

Correlative studies

pharmacological studyOTHER

Correlative studies

questionnaire administrationOTHER

Ancillary studies

fluorine F 18-clevudineRADIATION

Undergo fluorine F 18-clevudine PET/CT scan

positron emission tomography/computed tomographyPROCEDURE

Undergo fluorine F18-clevudine PET/CT scan

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy

Time frame: Up to 1 year

Incidence of adverse events

Time frame: Up to 24 hours after completion of study treatment