cu64-dota-trastuzumab pet and markers predicting response to neoadjuvant trastuzumab + pertuzum in her2+ breast cancer

Conditions: HER2 Positive Breast Carcinoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this phase ii trial studies how well copper cu64-dota-trastuzumab positron emission tomography (pet) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (her2) positive breast cancer that has spread from where it started to nearby tissue or lymph nodes. diagnostic procedures, such as copper cu 64 dota-trastuzumab pet, may help predict a patient's response to 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+ 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) versus (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 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.

Eligibility criteria:
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) and/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