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

Active, not recruiting

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT03738553
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Primary Completion: 2020-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States