Copper (Cu) 64-DOTA-Trastuzumab PET Imaging in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Patients With HER2 Positive Breast Cancer

PRIMARY OBJECTIVES:

I. To evaluate the standardized uptake value maximum (SUVmax) in patients with previously
untreated HER2+ breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate if the uptake of copper 64 Cu-64-DOTA-trastuzumab, a proposed indicator of
responsiveness to HER2-directed therapy, correlates with serpin peptidase inhibitor alpha-1
antiproteinase, antitrypsin, member 1 gene (SERPINA1) expression, which has been shown to be
associated with estrogen receptor positive (ER+)/ HER2+ patient survival, both in the
HER2+/ER+ patients and in all patients.

II. To compare uptake of copper Cu 64-DOTA-trastuzumab in the patients with complete
pathologic response (pCR) vs. non-pCR patients.

OUTLINE:

Patients receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving
copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48
hours, on day 1 and 2. Within 4 days after completion of PET scans, patients then receive
trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60
minutes. Treatment repeats every 21 days for 6 courses in the absence of disease progression
or unacceptable toxicity. Patients undergo surgery after 6 courses of trastuzumab and
pertuzumab.

After completion of study treatment, patients are followed up for 1 year.

Inclusion Criteria:

- Participants must be women who have histological confirmation of HER2 positive breast
cancer

- The primary tumor must be >= 2.0cm in size and/or have biopsy proven axillary nodes
that are >= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging
(MRI)

- The current cancer must over express HER2 as determined by immunohistochemistry (IHC)
or fluorescence in situ hybridization (FISH)

- Patients may not have received prior HER2 directed therapies

- Participants must have normal cardiac ejection fraction (per label, as defined as
institutional normal)

- Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and
chemotherapy

- Ability to provide informed consent

- Negative Serum Pregnancy test

Exclusion Criteria:

- Participants who are not considered candidates for pertuzumab + trastuzumab +
chemotherapy

- Concurrent malignancy other than non-melanoma skin cancer

- Patients must not have known metastatic disease

- Patients must not have received prior treatment for the current breast cancer