Can MRI predict breast cancer treatment success?
NCT ID NCT03738553
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether special MRI scans can detect early signs that anti-HER2 therapy is working in women with HER2-positive breast cancer. Thirteen participants received one dose of trastuzumab before surgery, and researchers compared MRI changes to immune cell levels in the tumor. The trial was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trastuzumab
- What this could lead to
- If successful, this could help doctors use MRI to quickly tell if anti-HER2 therapy is working, potentially guiding treatment decisions.
- What could go wrong
- This was a very small, terminated study with only 13 participants. The results may not apply to larger groups, and the approach may not prove reliable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
13 people
The number who actually took part.
- Started
-
Aug 2013
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a PI3K inhibitor boost presurgery breast cancer treatment?
- Can a platform trial match the right drug combo to each tumor?
- Can a shorter treatment hold off small HER2-Positive breast cancers?
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?
- Can a tailored Pre-Surgery regimen boost complete remission in HER2+ breast cancer?