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

Summary

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.

Conditions

• Bone Metastases
• HER2-positive Breast Cancer
• Liver Metastases
• Lung Metastases
• Recurrent Breast Cancer
• Soft Tissue Metastases
• Stage IV Breast Cancer

Interventions

RADIATION

fludeoxyglucose F 18

Undergo fludeoxyglucose F 18 PET/CT

PROCEDURE

positron emission tomography

Undergo fludeoxyglucose F 18 PET/CT

PROCEDURE

computed tomography

Undergo fludeoxyglucose F 18 PET/CT

BIOLOGICAL

trastuzumab

Given IV

RADIATION

copper Cu 64-DOTA-trastuzumab

Given IV

PROCEDURE

positron emission tomography

Undergo copper Cu-DOTA-trastuzumab PET

BIOLOGICAL

ado-trastuzumab emtansine

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Joanne Mortimer · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-07

Primary Completion

2021-12-07

Completion

2026-09-29

Countries

• United States

Study Locations