HER2-positive Breast CancerNCT03738553
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
An observational study of HER2-positive Breast Cancer, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- MRI and Trastuzumab
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
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.
Read the 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
- Being tested
- MRI, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI
TrastuzumabDrug
Single dose of Trastuzumab prior to surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startAug 2013
- Primary completionSep 2020
- Study completion1 Mar 2026
Why it stopped: Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savannah Partridge, University of Washington
- Investigators
- Savannah Partridge, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738553
- Sponsor's protocol ID
- 7889
- Other IDs
- RG3013002
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2018
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
- ClinicalTrials.gov ID
- NCT03738553
- Acronym / sponsor ID
- 7889
- Conditions
- HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIDiffusion Weighted Imaging and Dynamic Contrast enhanced MRI | Device | – |
| TrastuzumabSingle dose of Trastuzumab prior to surgery | Drug | – |
Primary outcome
Tumor infiltrating lymphocytes (TILs)
Time frame: 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
Results and safety
The study was stopped early (reason given: Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savannah Partridge principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor infiltrating lymphocytes (TILs) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.