HER2-positive Breast Cancer
Conditions
Brief summary
This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.
Detailed description
This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy MRI.
Interventions
DEVICEMRI
Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI
DRUGTrastuzumab
Single dose of Trastuzumab prior to surgery
Sponsors
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects at least 18 years of age. * Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive. * Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent. * Have tissue block available for review of experimental markers. * Be a candidate for MRI imaging. * Be willing to comply with scheduled visits required for the trial. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Recent therapy for breast cancer prior to baseline MRI. * Subjects may not receive other investigational agents during the study window for imaging. * Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet. * Pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor infiltrating lymphocytes (TILs) | 10 years | Determine whether early changes on MRI reflect the level of immune response (based on TILs) in the tumor as measured by histologic assessment after 1 cycle of anti-HER2 treatment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSavannah Partridge
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed