Monitoring HER2-positive breast cancer treatment with advanced imaging techniques

Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

This study is testing a new imaging agent to see if it can help track how well HER2-positive breast cancer patients are responding to their treatment with trastuzumab during chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Drugs / interventions: trastuzumab, chemotherapy
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04332588 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of an investigational imaging agent, [18F]FMISO, in conjunction with PET/MRI imaging to monitor the response of HER2-positive breast cancer patients to trastuzumab (Herceptin) during neoadjuvant chemotherapy. Participants will undergo a series of imaging visits based on their treatment cohort, which will include pre-study assessments and PET/MRI scans after the administration of the imaging agent. The study is designed to enhance understanding of treatment responses in HER2-positive breast cancer, although it will not alter current treatment plans for participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced HER2-positive breast cancer who are eligible for neoadjuvant therapy and have measurable disease.

Not a fit: Patients who are not eligible include those who are pregnant, lactating, or unable to provide informed consent, as well as those exceeding the weight limit for the imaging equipment.

Why it matters

Potential benefit: If successful, this study could improve the monitoring and prediction of treatment responses in HER2-positive breast cancer, leading to more personalized treatment strategies.

How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success in this context.

Eligibility criteria

Inclusion Criteria:

1. Patients must be ≥ 18 years old and ≤ 75 years old
2. HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and/or positive by 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
3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
4. Estimated life expectancy of greater than one year
5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)

Exclusion Criteria:

1. Inability to provide informed consent F
2. Weight over 350 lbs., due to the scanner bore size
3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study.
4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
5. Unable to lie still on the imaging table for one (1) hour
6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)

Where this trial is running

Birmingham, Alabama

• The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Jonathan McConathy, MD, PhD — University of Alabama at Birmingham
• Study coordinator: Anna Sorace, PhD

Conditions HER2-positive Breast Cancer