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

University of Southern California

Status: Terminated

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Treatments: Other: laboratory biomarker analysis; Other: pharmacological study; Radiation: fluorine F 18-clevudine; Procedure: positron emission tomography/computed tomography; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01712815

1B-11-9

NCI-2012-02041 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Diagnostic (fluorine F 18-clevudine PET/CT)

Experimental group

Description:

Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with 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.

Treatment:

Other: laboratory biomarker analysis

Other: questionnaire administration

Procedure: positron emission tomography/computed tomography

Radiation: fluorine F 18-clevudine

Other: pharmacological study