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NCT04273555 | RECRUITING | HER2-positive Breast Cancer

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

University of Alabama at Birmingham

Information provided by (Responsible Party):

Anna G. Sorace

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.

Condition or disease

HER2-positive Breast Cancer

Intervention/treatment

[18F]-FDG

Phase

PHASE1

PHASE2

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 Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
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)
Actual Study Start Date : 2026-03-01
Estimated Primary Completion Date : 2028-06-30
Estimated Study Completion Date : 2028-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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)
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients with Advanced PET/MR Imaging

Location Details

NCT04273555

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How to Participate

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Locations

RECRUITING

United States, Albama

The University of Alabama at Birmingham

Birmingham, Albama, United States, 35249