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

Primary Purpose

Breast Cancer, Stage IV Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positron emission tomography
copper Cu 64-DOTA-trastuzumab
Biopsy
Immunohistochemistry staining method
laboratory biomarker analysis
mutation analysis
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring HER2-positive breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 23, 2010
Last Updated
March 2, 2023
Sponsor
City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01093612
Brief Title
Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
Official Title
64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2011 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Stage IV Breast Cancer
Keywords
HER2-positive breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
PET images performed on a GE Discovery 16 Ste PET-CT scanner
Intervention Type
Radiation
Intervention Name(s)
copper Cu 64-DOTA-trastuzumab
Other Intervention Name(s)
64Cu-DOTA-trastuzumab
Intervention Description
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
biopsies
Intervention Description
Correlative Studies
Intervention Type
Other
Intervention Name(s)
Immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
Description
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).
Time Frame
24 hours after injection of 64 CU-DOTA-trastuzumab
Title
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours
Description
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).
Time Frame
48 hours after injection of 64 CU-DOTA-trastuzumab

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Mortimer
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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