RECRUITING

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

Conditions

HER2-positive Breast Cancer FDG-PET MRI quantitative imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-03-01

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04273555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Anna Sorace, PhD

CONTACT

205-934-3116

asorace@uabmc.edu

April Riddle, BSRT

CONTACT

205-934-6504

ariddle@uabmc.edu

Principal Investigator

Anna Sorace, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Anna Sorace, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

FDG-PET
MRI
quantitative imaging

Additional Relevant MeSH Terms

HER2-positive Breast Cancer