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

NCT ID: NCT03738553

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2026-03-31

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.

Conditions

HER2-positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MRI

Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI

Intervention Type: DEVICE

Trastuzumab

Single dose of Trastuzumab prior to surgery

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Savannah Partridge

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Savannah Partridge

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

Other Identifiers

RG3013002

Identifier Type: OTHER

Identifier Source: secondary_id

7889

Identifier Type: -

Identifier Source: org_study_id