Copper Cu 64-DOTA-Trastuzumab PET Imaging in Predicting Response to Treatment with Trastuzumab and Pertuzumab before Surgery in Patients with Locally Advanced HER2 Positive Breast Cancer

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To evaluate if the uptake of copper Cu 64-DOTA-trastuzumab (64 Cu-DOTA-trastuzumab), a proposed indicator of responsiveness to HER2-directed therapy, correlates with 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 the patients.

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

OUTLINE:

Patients receive trastuzumab intravenously (IV) over 15 minutes immediately before copper Cu 64 DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours on days 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 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.

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