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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer

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

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fluorine F 18-clevudine PET/CT)<br>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. | Other: laboratory biomarker analysis<br>* Correlative studies<br>Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Other: questionnaire administration<br>* Ancillary studies<br>Radiation: fluorine F 18-clevudine<br>* Undergo fluorine F 18-clevudine PET/CT scan<br>* Other names: 18F-FMAU;Procedure: positron emission tomography/computed tomography<br>* Undergo fluorine F18-clevudine PET/CT scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy |  | Up to 1 year | 
| Incidence of adverse events |  | Up to 24 hours after completion of study treatment |