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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01712815
• Other study ID #: 1B-11-9
• Secondary ID: NCI-2012-02041
• Status: Terminated
• Phase: N/A
• Start date: November 22, 2013
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• 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

Other:
• laboratory biomarker analysis
Correlative studies
• pharmacological study
Correlative studies
• questionnaire administration
Ancillary studies

Radiation:
• fluorine F 18-clevudine
Undergo fluorine F 18-clevudine PET/CT scan

Procedure:
• positron emission tomography/computed tomography
Undergo fluorine F18-clevudine PET/CT scan

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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