Pilot Study of 18F Fluoropaclitaxel (FPAC) in Breast Cancer Patients and Normal Volunteers: Dosimetry and Imaging Feasibility

Normal Volunteers

Inclusion Criteria:

- Subjects must be 18 years or older for inclusion in this study. Because no dosing or
adverse event data are currently available on the use of FPAC in patients <18 years
of age, children are excluded from this study but will be eligible for future
pediatric single-agent trials, if applicable.

- All subjects must sign a written informed consent document and a Health
Insurance Portability and Accountability Act (HIPAA) authorization in accordance
with institutional guidelines.

- If female, the subject must be postmenopausal for a minimum of one year, or
surgically sterile, or be within 14 days of onset of a menstrual period or have
a negative beta human chorionic gonadotropin (ßHCG) blood test.

- Subjects must have normal organ and marrow function as defined below:

- Leukocytes >3,000/μL

- absolute neutrophil count >1,500/μL

- platelets >100,000/μL

- total bilirubin within normal institutional limits

- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 times the
institutional upper limit of normal

- Creatinine within normal institutional limits OR, in subjects with creatinine
levels above institutional normal, creatinine clearance >60 mL/min/1.73 m2

Exclusion Criteria:

- Subject with a known bleeding disorder

- Subjects who have received chemotherapy within 1 year of entry into study

- Subjects with a history of liver or kidney disease

- Subjects who are receiving any other investigational agents

- Subjects having severe claustrophobia or other condition that would make them
unable to lie still for the duration of the study

- Subjects with immunodeficiencies that predispose a subject to specific or
non-specific mediator release

- Subjects with uncontrolled intercurrent illness, including but not limited to
ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements

- Subjects who are pregnant or lactating or who suspect they might be pregnant.
Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with FPAC, breastfeeding should be
discontinued if the mother receives FPAC.

Breast Cancer Patients

Inclusion Criteria:

- Subjects must have a history of histologically or cytologically confirmed breast
cancer with estimated lesion size of >1cm.

- Subjects must be 18 years or older for inclusion in this study. Because no
dosing or adverse event data are currently available on the use of FPAC in
patients <18 years of age, children are excluded from this study but will be
eligible for future pediatric single-agent trials, if applicable.

- All subjects must sign a written informed consent document and a HIPAA
authorization in accordance with institutional guidelines.

- If female, the subject must be postmenopausal for a minimum of one year, be
surgically sterile, be within 14 days of onset of a menstrual period, or have a
negative ßHCG blood test.

- Subjects must have normal organ and marrow function as defined below:

- Leukocytes >3,000/μL

- absolute neutrophil count >1,500/μL

- platelets >100,000/μL

- total bilirubin within normal institutional limits

- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 times the
institutional upper limit of normal

- Creatinine within normal institutional limits OR, in subjects with creatinine
levels above institutional normal, creatinine clearance >60 mL/min/1.73 m2

Exclusion Criteria:

•as above