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

Status: Temporarily Closed to Accrual

Description

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.

Eligibility Criteria

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

Locations & Contacts

California

Los Angeles
Los Angeles County-USC Medical Center
Status: Temporarily closed to accrual
Contact: Peter Stephen Conti
Phone: 323-442-5940
Email: Peter.Conti@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Peter Stephen Conti
Phone: 323-442-3216
Email: PCONTI@USC.EDU

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Diagnostic

Lead Organization

Lead Organization
USC / Norris Comprehensive Cancer Center

Principal Investigator
Peter Stephen Conti

Trial IDs

Primary ID 1B-11-9
Secondary IDs NCI-2012-02041
Clinicaltrials.gov ID NCT01712815