NCT01093612

Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer

64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer

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

Summary

RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer. II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease. III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway. OUTLINE: This is a part one dose-determining study followed by a part two study. PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of the study.

Conditions

• Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	positron emission tomography	PET images performed on a GE Discovery 16 Ste PET-CT scanner
RADIATION	copper Cu 64-DOTA-trastuzumab	15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
PROCEDURE	Biopsy	Correlative Studies
OTHER	Immunohistochemistry staining method	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	mutation analysis	Correlative studies

Timeline

• Start date: 2011-03-16
• Primary completion: 2018-10-23
• Completion: 2026-09-08
• First posted: 2010-03-26
• Last updated: 2025-11-14
• Results posted: 2023-03-28

Locations

1 site across 1 country: United States