Multiparametric MRI for Assessing Breast Cancer Response... | NCT03738553

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

NCT03738553

Sponsor

University of Washington

Status

Terminated

Last Update Posted

May 4, 2026Actual

Enrollment

13Actual

Phase

Not provided

Conditions

HER2-positive Breast Cancer

Interventions

MRI
Trastuzumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RG3013002	Other Identifier	Fred Hutch/University of Washington Cancer Consortium

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.

Expanded Access Info

Start Date

Aug 2013Actual

Primary Completion Date

Sep 2020Actual

Completion Date

Mar 1, 2026Actual

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Nov 8, 2018

First Posted Date

Nov 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 4, 2026Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI
Trastuzumab	Drug	Single dose of Trastuzumab prior to surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins