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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Joanne E. Mortimer
Phone: 626-256-4673ext81218
Email: jmortimer@coh.org

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
City of Hope Comprehensive Cancer Center

Principal Investigator
Joanne E. Mortimer

Trial IDs

Primary ID 16079
Secondary IDs NCI-2016-00570
Clinicaltrials.gov ID NCT02827877