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

HER2-positive Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04273555
• Other study ID #: R19-149
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2025
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Anna Sorace, PhD
• Phone: 205-934-3116
• Email: asorace[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• [18F]-FDG
[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline measure of PET standardized uptake value (SUV).	Compare baseline metrics from PET/MRI	Baseline imaging visit 1
Primary	Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.	Compare baseline metrics from PET/MRI	Baseline imaging visit 1
Primary	Baseline measure of signal enhancement ratio (SER) from MRI.	Compare baseline metrics from PET/MRI	Baseline imaging visit 1
Primary	Changes in SER from MRI	Compare percent change of SER from imaging visit 3 to the baseline.	Baseline through 6 months
Primary	Changes in ADC from MRI	Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.	Baseline through 6 months
Primary	Changes in SUV from PET	Compare percent change of SUV from imaging visit 3 to the baseline.	Baseline through 6 months
Secondary	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).	Baseline through 5 year follow-up
Secondary	Changes in ADC (mm2/sec) from MRI.	Compare percent change from imaging visit 2 to the baseline.	Baseline through 2 months
Secondary	Changes in SER from MRI.	Compare percent change from imaging visit 2 to the baseline.	Baseline through 2 months
Secondary	Changes in SUV from PET.	Compare percent change from imaging visit 2 to the baseline.	Baseline through 2 months