The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer

Cohorts of 3 will be treated each at different dose levels and images will be taken at 4
time points. For dosimetry estimates, there will be a 20-24 hr time point
post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and
dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will
eliminate that 4th scan for all other patients. Urine and blood samples will be collected at
5 time points, and an additional blood and urine sample will be collected for dosimetry
analysis at 30~60 min.

Inclusion Criteria:

- Patients with newly diagnosed stage I-IV breast cancer (tumor size

- 2cm in imaging examinations) who are scheduled to start systemic therapy.

- Patients must have histological diagnosis of invasive breast cancer.

- Extent of disease will be determined by physical examination and conventional
radiological studies.

- Must be age 18 or older.

- ECOG performance status 0-2.

- Patients with history of prior malignancies must be disease-free for at least 5 years
of study entry.

- Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul,
platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is
acceptable).

- Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.

- Adequate kidney function (creatinine < 1.5 mg/dL).

Exclusion Criteria:

- Patients who received previous chemotherapy for the newly diagnosed breast cancer.

- No evidence of primary breast lesion (e.g. T0, Tx).

- Pregnant women or sexually active women of childbearing potential who are not
practicing adequate contraception are excluded.

- Patients with myocardial infarction within 6 months of study entry; unstable angina
pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are
excluded.

- Patients with history of hypersensitivity/allergy to Chitosan/Chitin related
shellfish foods.