Overview

This trial is active, not recruiting.

Conditions breast cancer, stage iv breast cancer
Treatments positron emission tomography, copper cu 64-dota-trastuzumab, biopsy, immunohistochemistry staining method, laboratory biomarker analysis, mutation analysis
Sponsor City of Hope Medical Center
Start date March 2011
End date April 2017
Trial size 18 participants
Trial identifier NCT01093612, 09101, BC095002, NCI-2010-00322

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
positron emission tomography FDG-PET
PET images performed on a GE Discovery 16 Ste PET-CT scanner
copper cu 64-dota-trastuzumab 64Cu-DOTA-trastuzumab
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
biopsy biopsies
Correlative Studies
immunohistochemistry staining method immunohistochemistry
Correlative studies
laboratory biomarker analysis
Correlative studies
mutation analysis
Correlative studies

Primary Outcomes

Measure
Dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET
time frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab
Correlation of tumor uptake on 64Cu-DOTA-trastuzumab PET with tumor expression of HER2
time frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab
Relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway
time frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer
Principal investigator Joanne Mortimer
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.