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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Stage IV Breast Cancer

• Registration Number: NCT01093612
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Study Start: 2011-03-16
• Primary Completion: 2018-10-23
• Results First Submitted: 2023-03-02
• Results First Submitted QC: 2023-03-02
• Results First Posted: 2023-03-28
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-10
• Last Update Posted: 2025-11-14
• Study Completion: 2026-09-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours	24 hours after injection of 64 CU-DOTA-trastuzumab	Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test.; Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight \[g\]/injected activity decay-corrected to time of scan).
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours	48 hours after injection of 64 CU-DOTA-trastuzumab	Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test.; Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight \[g\]/injected activity decay-corrected to time of scan).

Trial Locations

Locations (1)

City of Hope; 🇺🇸 Duarte, California, United States