Imaging breast cancer with a special tracer to predict treatment response
PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
EARLY_PHASE1 · University of Alabama at Birmingham · NCT03321045
This study is testing a special imaging agent to see if it can help identify breast cancer patients who will respond well to HER2-targeted treatments.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham (other) |
| Drugs / interventions | radiation, trastuzumab |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT03321045 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of 89Zr-trastuzumab as a PET imaging agent to identify breast cancer patients who are likely to respond to HER2-targeted therapies. It aims to demonstrate the feasibility of using PET/MRI imaging with this agent and to evaluate the correlation between tumor uptake of 89Zr-trastuzumab and HER2 positivity, as well as the response to HER2 therapy. The study will involve patients diagnosed with HER2 positive breast cancer who are eligible for treatment with anti-HER2 agents.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with HER2 positive breast cancer who are eligible for anti-HER2 therapy.
Not a fit: Patients who are pregnant, unable to provide informed consent, or have contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help tailor HER2-targeted therapies to patients who are most likely to benefit, improving treatment outcomes.
How similar studies have performed: Other studies have shown promise in using imaging agents for predicting treatment response, but this specific approach with 89Zr-trastuzumab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be at least 18 years of age. * Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2 * Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1 * Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans Exclusion Criteria: * Inability to provide informed consent * Pregnancy * Inability to lie still for the imaging study * Weight over 350 lbs., due to the scanner bore size * Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Where this trial is running
Birmingham, Alabama
- The Kirklin Clinic — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Suzanne E Lapi, PhD — University of Alabama at Birmingham
- Study coordinator: Denise Jeffers, PharmD
- Email: charlottejeffers@uabmc.edu
- Phone: 205-975-6469
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.
Conditions: Breast Cancer, 89Zr-Trastuzumab, HER2 Imaging