Study to see if PET/MRI can predict breast cancer treatment success before It's visible
NCT ID NCT04273555
First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 3 times
Summary
This study was designed to see if a combination of PET and MRI scans could detect early signs that treatment is working in people with stage IV HER2-positive breast cancer. The plan was to scan participants up to three times over six months and compare the images to standard measures of disease progression. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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: * Patients must be ≥ 18 years old and ≤ 75 years old * Patients with HER2+ metastatic breast cancer * HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility * Estrogen/progesterone receptor positive OR negative disease allowed * Patients must have measurable disease in one metastatic lesion per RECIST v 1.1 * Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen * Estimated life expectancy of greater than six months Exclusion Criteria: * Children, less than 18 years of age, will be excluded from this study * Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease * Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment * Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment * Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent). * Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials * Unable to lie still on the imaging table for one (1) hour * Inability to receive gadolinium-based contrast agent * Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, \> body mass index (BMI) 36)
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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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The University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug HER2 attack vs one: which First-Line strategy helps advanced breast cancer patients live longer?
- 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?