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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01093612
• Other study ID #: 09101
• Secondary ID: NCI-2010-00322BC
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 16, 2011
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 30, 2024
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Eligibility Part I (Determination of the cold dose)

• 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 within 28 days prior to study. 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 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.

• The cancer must over express HER2 as determined by IHC and FISH.

• Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.

• Participants must have normal cardiac ejection fraction.

Eligibility Part 2 (correlation of HER2 expression with PET uptake)

• 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 within 28 days prior to study. 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 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.

• Participants with HER2 1+, 2+ and 3+ by IHC are eligible.

• Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.

• Participants must have normal cardiac ejection fraction.

Ineligibility

• Participants who have received trastuzumab within the prior 2 months

• Participants who are not considered candidates for trastuzumab

• Metastatic disease in a single site

• No metastatic site greater than or equal to 2 cm

• Concurrent malignancy other than skin cancer

• Inability to provide informed consent

• Participants who are pregnant

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stage IV Breast Cancer

Intervention

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
• laboratory biomarker analysis
Correlative studies

Genetic:
• mutation analysis
Correlative studies

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours	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).	24 hours after injection of 64 CU-DOTA-trastuzumab
Primary	Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours	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).	48 hours after injection of 64 CU-DOTA-trastuzumab