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

Not Applicable

Terminated

• Conditions: Stage IV Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Stage IIIA Breast Cancer; HER2-positive Breast Cancer; Stage IIIC Breast Cancer; Recurrent Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer
• Interventions: Other: laboratory biomarker analysis; Other: pharmacological study; Other: questionnaire administration; Radiation: fluorine F 18-clevudine; Procedure: positron emission tomography/computed tomography

• Registration Number: NCT01712815
• Lead Sponsor: University of Southern California

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-20
• Study First Posted: 2012-10-24
• Study Start: 2013-11-22
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluorine F 18-clevudine PET/CT)	questionnaire administration	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.
Diagnostic (fluorine F 18-clevudine PET/CT)	positron emission tomography/computed tomography	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.
Diagnostic (fluorine F 18-clevudine PET/CT)	pharmacological study	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.
Diagnostic (fluorine F 18-clevudine PET/CT)	fluorine F 18-clevudine	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.
Diagnostic (fluorine F 18-clevudine PET/CT)	laboratory biomarker analysis	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States