Clinical Trial · NCT02827877

Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer

Overview

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.

Sponsor

City of Hope Medical Center

Phase

Phase 2

Contacts

Joanne Mortimer (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02827877

Drug / Compound

DOTA-trastuzumab

Isotope(s):

Target(s):

HER2

Ligand Class: Antibodies

Chelator: DOTA

Eligibility

Inclusion

Patients may not have received prior HER2 directed therapies
The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
Negative Serum Pregnancy test
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)
Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal)

Exclusion

Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
Patients must not have received prior treatment for the current breast cancer
Patients must not have known metastatic disease