HER2-positive Breast CancerPhase 1/2NCT04273555
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
A Phase 1/2 study testing [18F]-FDG in people with HER2-positive Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- [18F]-FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Jun 2028
- Phase
- Phase 1/2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
Read the detailed description
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- [18F]-FDG
- Keywords
- FDG-PET, MRI, quantitative imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FDGDrug
[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
| Study group | Role | What they receive |
|---|---|---|
| [18F]-Fluorodeoxyglucose (FDG) PET/ MRI | Experimental | Not described Receives: Drug: [18F]-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline measure of PET standardized uptake value (SUV).
Compare baseline metrics from PET/MRI
Measured: Baseline imaging visit 1
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Compare baseline metrics from PET/MRI
Measured: Baseline imaging visit 1
Baseline measure of signal enhancement ratio (SER) from MRI.
Compare baseline metrics from PET/MRI
Measured: Baseline imaging visit 1
Changes in SER from MRI
Compare percent change of SER from imaging visit 3 to the baseline.
Measured: Baseline through 6 months
Changes in ADC from MRI
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
Measured: Baseline through 6 months
Changes in SUV from PET
Compare percent change of SUV from imaging visit 3 to the baseline.
Measured: Baseline through 6 months
Secondary outcomes (4)
Follow-up
Compare changes in imaging metrics to disease progression (defined as clinical progression of disease through increase in lesion size or increase in number of lesions).
Measured: Baseline through 5 year follow-up
Changes in ADC (mm2/sec) from MRI.
Compare percent change from imaging visit 2 to the baseline.
Measured: Baseline through 2 months
Changes in SER from MRI.
Compare percent change from imaging visit 2 to the baseline.
Measured: Baseline through 2 months
Changes in SUV from PET.
Compare percent change from imaging visit 2 to the baseline.
Measured: Baseline through 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Unable to recruit for this study.
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 Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna G. Sorace, University of Alabama at Birmingham
- Investigators
- Anna Sorace, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273555
- Sponsor's protocol ID
- IRB-300005278 R19-149
- Other IDs
- UAB
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT04273555
- Acronym / sponsor ID
- IRB-300005278 R19-149
- Conditions
- HER2-positive Breast Cancer
- Keywords
- FDG-PET, MRI, quantitative imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Feb 2020 (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.
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
Detailed description
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-Fluorodeoxyglucose (FDG) PET/ MRI | Experimental | Drug: [18F]-FDG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| [18F]-FDG[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months. | Drug | [18F]-Fluorodeoxyglucose (FDG) PET/ MRI |
Primary outcome
Baseline measure of PET standardized uptake value (SUV).
Time frame: Baseline imaging visit 1
Compare baseline metrics from PET/MRI
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Time frame: Baseline imaging visit 1
Compare baseline metrics from PET/MRI
Baseline measure of signal enhancement ratio (SER) from MRI.
Time frame: Baseline imaging visit 1
Compare baseline metrics from PET/MRI
Changes in SER from MRI
Time frame: Baseline through 6 months
Compare percent change of SER from imaging visit 3 to the baseline.
Changes in ADC from MRI
Time frame: Baseline through 6 months
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
Changes in SUV from PET
Time frame: Baseline through 6 months
Compare percent change of SUV from imaging visit 3 to the baseline.
4 secondary outcomes
Follow-up
Time frame: Baseline through 5 year follow-up
Changes in ADC (mm2/sec) from MRI.
Time frame: Baseline through 2 months
Changes in SER from MRI.
Time frame: Baseline through 2 months
Changes in SUV from PET.
Time frame: Baseline through 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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.
Anna Sorace, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]-FDG in people with HER2-positive Breast Cancer, run by University of Alabama at Birmingham 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 9 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: withdrawn, as of the sponsor's last update on 1 Jul 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Baseline measure of PET standardized uptake value (SUV). (time frame: Baseline imaging visit 1). The study lists 6 primary outcomes in all. 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 1 Jul 2026.