Clinical trial NCT01712815: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer
Official title: Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-10-24
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy
timeFrame: Up to 1 year
measure: Incidence of adverse events
timeFrame: Up to 24 hours after completion of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Peter Conti, MD
role: PRINCIPAL_INVESTIGATOR
References: