Breast Cancer With Low to Intermediate HER2 ExpressionPOCEBNCT07630402
Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
A study testing Echocardiogram in people with Breast Cancer With Low to Intermediate HER2 Expression, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a personalized, risk-stratified surveillance strategy can safely reduce unnecessary cardiac imaging while preserving early detection of treatment-related cardiotoxicity in women with breast cancer (BC) receiving HER2-targeted therapy (HER2-TT). Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Breast Cancer With Low to Intermediate HER2 Expression
- What is being tested?
- Echocardiogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex, age 18-79 years.
- Histologically confirmed HER2-positive BC scheduled for ≈12 months of adjuvant HER2-TT
- Baseline LVEF ≥ 55 % by 2-D echocardiography.
- Ability to provide informed consent.
Who cannot join
- Prior HF, myocardial infarction, or cardiomyopathy.
- Atrial fibrillation or significant valvular heart disease.
- Cumulative anthracycline dose ≥ 250 mg/m².
- Pregnancy or lactation.
- Inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wilmot Cancer Center
Rochester, New York, 14642
Farhan Bajwa, MD, FACC
About this study
Official title: Pilot Study for Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
The purpose of this study is to determine whether a personalized, risk-stratified surveillance strategy can safely reduce unnecessary cardiac imaging while preserving early detection of treatment-related cardiotoxicity in women with breast cancer (BC) receiving HER2-targeted therapy (HER2-TT).
- Being tested
- Echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramProcedure or surgery
12-lead echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care Group | Active comparator | Participants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT). Receives: Procedure: Echocardiogram |
| Judicious-imaging Group | Experimental | The Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab). Receives: Procedure: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of imaging tests
Measured: At the end of therapy, approximately 457 days
Time to completion of HER 2 (human epidermal growth factor receptor 2) target therapy in days
Measured: end of therapy, approximately 457 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start17 Nov 2025
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer With Low to Intermediate HER2 ExpressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Bajwa, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630402
- Sponsor's protocol ID
- STUDY00010778
- Acronym
- POCEB
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT07630402
- Acronym / sponsor ID
- POCEB / STUDY00010778
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 5 Jun 2026 (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 this study is to determine whether a personalized, risk-stratified surveillance strategy can safely reduce unnecessary cardiac imaging while preserving early detection of treatment-related cardiotoxicity in women with breast cancer (BC) receiving HER2-targeted therapy (HER2-TT).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care Group | Active comparator | Procedure: EchocardiogramParticipants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT). |
| Judicious-imaging Group | Experimental | Procedure: EchocardiogramThe Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female sex, age 18-79 years.
- Histologically confirmed HER2-positive BC scheduled for ≈12 months of adjuvant HER2-TT
- Baseline LVEF ≥ 55 % by 2-D echocardiography.
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- Prior HF, myocardial infarction, or cardiomyopathy.
- Atrial fibrillation or significant valvular heart disease.
- Cumulative anthracycline dose ≥ 250 mg/m².
- Pregnancy or lactation.
- Inability to comply with study procedures.
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 |
|---|---|---|
| Echocardiogram12-lead echocardiogram | Procedure or surgery | Judicious-imaging Group, Standard-of-care Group |
Primary outcome
Total Number of imaging tests
Time frame: At the end of therapy, approximately 457 days
Time to completion of HER 2 (human epidermal growth factor receptor 2) target therapy in days
Time frame: end of therapy, approximately 457 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiogram in people with Breast Cancer With Low to Intermediate HER2 Expression, run by University of Rochester 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaily LaForce (585-274-2808, kaily_laforce@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of imaging tests (time frame: At the end of therapy, approximately 457 days). The study lists 2 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 5 Jun 2026.