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

Who is this study for? Patients with HER2+ breast cancer
What treatments are being studied? [18F]FMISO PET/MRI imaging
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be ≥ 18 years old and ≤ 75 years old

• 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

• Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment

• Estimated life expectancy of greater than one year

• Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)

Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Anna Sorace, PhD
asorace@uabmc.edu
205-934-3116
Backup
Sebastian Eady
smeady@uabmc.edu
2059962636
Time Frame
Start Date: 2025-04
Estimated Completion Date: 2027-08
Participants
Target number of participants: 25
Treatments
Experimental: Herceptin monotherapy cohort
Herceptin monotherapy cohort. Locally advanced HER2+ breast cancer patients receiving neoadjuvant Herceptin monotherapy prior to combination therapy will undergo three contrast-enhanced \[18F\]FMISO PET/MRI scans. Each imaging session will be identical. Imaging session one will be after diagnosis and before beginning monotherapy. Imaging session two will be within 10 days prior to beginning combination therapy with targeted HER2 agents. Imaging session three will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.
Experimental: Combination therapy cohort
Locally advanced HER2+ breast cancer patients that receiving neoadjuvant combination therapy including Herceptin will undergo two contrast-enhanced \[18F\]FMISO PET/MRI imaging. Imaging session one will be after diagnosis and before beginning combination therapy. Imaging session two will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov