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.



Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
Accepts 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)

Study Design

Phase 1/Phase 2
Study Type
Intervention Model
Single Group Assignment
Primary Purpose
None (Open Label)

Arm Groups

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

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35249
April Riddle, BSRT

More Details

University of Alabama at Birmingham

Study Contact

Anna Sorace, PhD

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.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.