89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

Inclusion Criteria:

- Female patients 18 years of age or older

- Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 biopsy proven
breast cancer

- Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 OR HER2negative
(0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer

- Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies
(ultrasonography, mammography, CT or MRI) or physical examination

- Able to give informed consent

- Not currently pregnant or nursing: Subject must be surgically sterile (has had a
documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal
(cessation of menses for more than 1 year), non-lactating, or of childbearing
potential for whom a urine pregnancy test (with the test performed within the 24 hour
period immediately prior to administration of 89Zr-trastuzumab) is negative

- Patients currently receiving trastuzumab therapy with or without other types of
systemic therapy can participate if their disease progresses (development of new
lesion(s) or worsening of known lesion(s) based on imaging modalities or physical
examination.

Exclusion Criteria:

- Patients with other invasive malignancies, with the exception of non- melanoma skin
cancer, who had (or have) any evidence of the other cancer present within the last 5
years

- Unable to tolerate 60 min of PET imaging per imaging session