Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
HER2-positive Breast Cancer
About this trial
This is an interventional diagnostic trial for HER2-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Inability to provide informed consent F
- Weight over 350 lbs., due to the scanner bore size
- 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.
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
- Unable to lie still on the imaging table for one (1) hour
- contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
Sites / Locations
- The University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Herceptin monotherapy cohort
Combination therapy 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.
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.