Using advanced imaging to monitor treatment response in HER2-positive breast cancer
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)
This study is testing a new imaging method to see how well treatment works for people with stage IV HER2-positive breast cancer who are just starting therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04273555 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a new imaging technique, combining FDG-PET and MRI, to monitor treatment responses in patients with stage IV HER2-positive breast cancer. Participants will undergo imaging tests before and during therapy to assess how well the cancer responds to treatment. The study will include patients who are newly starting HER2-targeted therapies and have measurable disease. The goal is to clarify the role of this imaging method in tracking treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with HER2-positive metastatic breast cancer who are eligible for a new HER2-targeted treatment regimen.
Not a fit: Patients who are not HER2-positive or those with other types of breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of treatment responses in HER2-positive breast cancer, allowing for timely adjustments in therapy.
How similar studies have performed: While the use of PET/MRI in breast cancer is still being explored, similar imaging approaches have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Birmingham, Alabama
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Anna Sorace, PhD — University of Alabama at Birmingham
- Study coordinator: Anna Sorace, PhD
- Email: asorace@uabmc.edu
- Phone: 205-934-3116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.