Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

NCT03738553 | Terminated FDA Drug FDA Device

• 2 other identifiers: 7889RG3013002
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor infiltrating lymphocytes (TILs)

  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

  10 years

Interventions

MRI DEVICE

Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI

Trastuzumab DRUG

Single dose of Trastuzumab prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Savannah Partridge

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: August 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)