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

NCT04273555 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: R19-149UAB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Keywords

FDG-PET; MRI; quantitative imaging

Outcome Measures

Primary Outcomes (6)

• Baseline measure of PET standardized uptake value (SUV).

  Compare baseline metrics from PET/MRI

  Baseline imaging visit 1

• Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.

  Compare baseline metrics from PET/MRI

  Baseline imaging visit 1

• Baseline measure of signal enhancement ratio (SER) from MRI.

  Compare baseline metrics from PET/MRI

  Baseline imaging visit 1

• Changes in SER from MRI

  Compare percent change of SER from imaging visit 3 to the baseline.

  Baseline through 6 months

• Changes in ADC from MRI

  Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.

  Baseline through 6 months

• Changes in SUV from PET

  Compare percent change of SUV from imaging visit 3 to the baseline.

  Baseline through 6 months

Secondary Outcomes (4)

• Follow-up

  Baseline through 5 year follow-up

• Changes in ADC (mm2/sec) from MRI.

  Baseline through 2 months

• Changes in SER from MRI.

  Baseline through 2 months

• Changes in SUV from PET.

  Baseline through 2 months

Study Arms (1)

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

EXPERIMENTAL

Drug: [18F]-FDG

Interventions

[18F]-FDG DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Anna Sorace, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Radiology and Biomedical Engineering Director, The Small Animal Facility in the Advanced Medical Imaging Research Division

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 18, 2020
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)