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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

Trial Status: Active

This phase II trial studies how well copper Cu 64-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.

Inclusion Criteria

  • 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

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


City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Joanne E. Mortimer
Phone: 626-256-4673ext81218


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

Lead Organization
City of Hope Comprehensive Cancer Center

Principal Investigator
Joanne E. Mortimer

  • Primary ID 16079
  • Secondary IDs NCI-2016-00570
  • ID NCT02827877