Clinical Trial · NCT02226276

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

Overview

This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive substance. Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine.

Sponsor

City of Hope Medical Center

Phase

N/A

Contacts

Joanne Mortimer (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02226276

Drug / Compound

fludeoxyglucose

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

trastuzumab

Isotope(s):

Target(s):

HER2

Ligand Class: Antibodies

Chelator: DOTA

Eligibility

Inclusion

Patients must have adequate cardiac function; left ventricular ejection fraction (LVEF) \>= 50% as determined by multi gated acquisition (MUGA) scan or echocardiogram
Patients that may need dose reduction to commence cycle 1 treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained prior to initiation of chemotherapy; it should be performed within 28 days prior to enrollment (patients with a biopsy of recurrent disease that is HER2-positive and have not received HER2-directed therapy since the biopsy can exceed the 28-day window up to 6 months); patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
At least 1 site of metastasis \>= 20 mm in mean diameter must be identified
The cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
Patients may not have received trastuzumab within 6 weeks of projected 64Cu-DOTA-trastuzumab/PET-CT
Negative serum pregnancy test (female of childbearing potential only)
Participants must have normal cardiac ejection fraction

Exclusion

No metastatic sites \>= 20 mm
Participants who have received trastuzumab within the prior 36 days
Participants who are not considered candidates for ado-trastuzumab-emtansine