Clinical trial NCT03738553: Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
Official title: Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HER2-positive Breast Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor infiltrating lymphocytes (TILs)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Savannah Partridge
role: PRINCIPAL_INVESTIGATOR
References: