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Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging

Primary Purpose

HER2-positive Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]-FDG
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HER2-positive Breast Cancer focused on measuring FDG-PET, MRI, quantitative imaging

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be ≥ 18 years old and ≤ 75 years old
  • Patients with HER2+ metastatic breast cancer
  • HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
  • Estrogen/progesterone receptor positive OR negative disease allowed
  • Patients must have measurable disease in one metastatic lesion per RECIST v 1.1
  • Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen
  • Estimated life expectancy of greater than six months

Exclusion Criteria:

  • Children, less than 18 years of age, will be excluded from this study
  • Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease
  • Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment
  • Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment
  • Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
  • Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials
  • Unable to lie still on the imaging table for one (1) hour
  • Inability to receive gadolinium-based contrast agent
  • Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, > body mass index (BMI) 36)

Sites / Locations

  • The University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]-Fluorodeoxyglucose (FDG) PET/ MRI

Arm Description

Outcomes

Primary Outcome Measures

Baseline measure of PET standardized uptake value (SUV).
Compare baseline metrics from PET/MRI
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Compare baseline metrics from PET/MRI
Baseline measure of signal enhancement ratio (SER) from MRI.
Compare baseline metrics from PET/MRI
Changes in SER from MRI
Compare percent change of SER from imaging visit 3 to the baseline.
Changes in ADC from MRI
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
Changes in SUV from PET
Compare percent change of SUV from imaging visit 3 to the baseline.

Secondary Outcome Measures

Follow-up
Compare changes in imaging metrics to disease progression (defined as clinical progression of disease through increase in lesion size or increase in number of lesions).
Changes in ADC (mm2/sec) from MRI.
Compare percent change from imaging visit 2 to the baseline.
Changes in SER from MRI.
Compare percent change from imaging visit 2 to the baseline.
Changes in SUV from PET.
Compare percent change from imaging visit 2 to the baseline.

Full Information

First Posted
January 30, 2020
Last Updated
December 19, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04273555
Brief Title
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
Official Title
Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
Detailed Description
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
FDG-PET, MRI, quantitative imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]-Fluorodeoxyglucose (FDG) PET/ MRI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F]-FDG
Intervention Description
[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
Primary Outcome Measure Information:
Title
Baseline measure of PET standardized uptake value (SUV).
Description
Compare baseline metrics from PET/MRI
Time Frame
Baseline imaging visit 1
Title
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Description
Compare baseline metrics from PET/MRI
Time Frame
Baseline imaging visit 1
Title
Baseline measure of signal enhancement ratio (SER) from MRI.
Description
Compare baseline metrics from PET/MRI
Time Frame
Baseline imaging visit 1
Title
Changes in SER from MRI
Description
Compare percent change of SER from imaging visit 3 to the baseline.
Time Frame
Baseline through 6 months
Title
Changes in ADC from MRI
Description
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
Time Frame
Baseline through 6 months
Title
Changes in SUV from PET
Description
Compare percent change of SUV from imaging visit 3 to the baseline.
Time Frame
Baseline through 6 months
Secondary Outcome Measure Information:
Title
Follow-up
Description
Compare changes in imaging metrics to disease progression (defined as clinical progression of disease through increase in lesion size or increase in number of lesions).
Time Frame
Baseline through 5 year follow-up
Title
Changes in ADC (mm2/sec) from MRI.
Description
Compare percent change from imaging visit 2 to the baseline.
Time Frame
Baseline through 2 months
Title
Changes in SER from MRI.
Description
Compare percent change from imaging visit 2 to the baseline.
Time Frame
Baseline through 2 months
Title
Changes in SUV from PET.
Description
Compare percent change from imaging visit 2 to the baseline.
Time Frame
Baseline through 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be ≥ 18 years old and ≤ 75 years old Patients with HER2+ metastatic breast cancer HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility Estrogen/progesterone receptor positive OR negative disease allowed Patients must have measurable disease in one metastatic lesion per RECIST v 1.1 Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen Estimated life expectancy of greater than six months Exclusion Criteria: Children, less than 18 years of age, will be excluded from this study Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent). Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials Unable to lie still on the imaging table for one (1) hour Inability to receive gadolinium-based contrast agent Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, > body mass index (BMI) 36)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Sorace, PhD
Phone
205-934-3116
Email
asorace@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle, BSRT
Phone
205-934-6504
Email
ariddle@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Sorace, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Riddle, BSRT
Phone
205-934-6504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Anna Sorace, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging

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