NCT02226276

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

A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Correlate uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by serial 18F-fludeoxyglucose (FDG) (fludeoxyglucose F 18)/PET-computed tomography (CT). II. Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients who do not respond to ado-trastuzumab emtansine. III. Obtain tumor tissue for subsequent assessment of the presence of putative molecular mechanisms of resistance (MMRs) to ado-trastuzumab emtansine. When funding becomes available, those samples will be used to explore the correlation between the presence of MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as measured with PET/CT. OUTLINE: Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks for 1 year after initiation of treatment until disease progression. After completion of study treatment, patients are followed up for 1 year.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-01-07
• Primary completion: 2021-12-07
• Completion: 2026-09-29
• First posted: 2014-08-27
• Last updated: 2026-02-13
• Results posted: 2022-07-20

Locations

1 site across 1 country: United States