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
- Have histological confirmation of HER2 positive breast cancer
- The primary tumor must be >= 2.0 cm in size and/or have biopsy proven axillary nodes that are >= 2.0 cm 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
- 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
I. To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2 positive (+) breast cancer.
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.
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.
Trial Phase Phase II
Trial Type Treatment
City of Hope Comprehensive Cancer Center
Joanne E. Mortimer
- Primary ID 16079
- Secondary IDs NCI-2016-00570
- Clinicaltrials.gov ID NCT02827877