Breast CancerPhase 1Breast 54NCT04796220
Focused Ultrasound and Gemcitabine in Breast Cancer
A Phase 1 study testing Focused Ultrasound and Gemcitabine and Focused Ultrasound in people with Breast Cancer and Breast Neoplasms, run by Patrick Dillon, MD at 1 site in United States.
Trial summary
This study will test the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We will be testing the effects of each of these regimens on cells in the immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Focused Ultrasound and Gemcitabine and Focused Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to Feb 2030
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease Status
- Patients must have histologically confirmed, newly diagnosed breast cancer, stage 1-3 disease and be appropriate surgical candidates for complete resection. Recurrent disease patients must have disease localized to the breast, chest wall or axilla and must be surgical candidates for completion resection of recurrent disease.
- If genomic profiling is performed, then the results must indicate that the cancer is high-risk
- Any receptor status may be eligible (estrogen receptor, progesterone receptor, HER2 receptor)
- Patients must have a lesion in the breast/chest wall/axilla that is accessible to focused ultrasound ablation.
- Accessible is defined as the following:
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- A targetable portion of the tumor must be ≥ 5mm from the skin
- The rib cage should not be in the prefocal ultrasound path or behind the target area of the lesion (minimum distance from the posterior aspect of the target area to rib cage must be at least 10 mm).
- Participants must have at least one high-risk feature of breast cancer (tumor size and nodal status may be measured by mammogram, MRI, US, CT, or calipers):
- Triple negative breast cancer with Tumor size ≥10mm
- Lymph node involvement by imaging or biopsy (any receptor status, any size)
- Tumor size ≥ 20mm (estrogen receptor positive, HER2 negative)
- Tumor size ≥ 10mm (HER2 receptor positive, any ER status)
- Tumor size ≥ 10mm and Oncotype or Mammaprint high status (estrogen receptor positive, HER2 negative) *If patient has more than one tumor, then the treated tumor must have a high-risk feature (if 2 tumors meet high risk criteria), they may both be treated).
- Willing and able to provide written consent
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ≥ 18 years
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
- ECOG performance status of 0-2
- Adequate organ function
- Agreement to adhere to lifestyle considerations throughout the study duration
Who cannot join
- Received other treatment (standard or investigational) for their current breast cancer.
- Pregnant or lactating
- Diagnosis of immunodeficiency or receiving systemic steroid therapy within 7 days prior to enrollment with the following exceptions:
- In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed; however, daily doses of 10 mg or more of prednisone (or equivalent) per day administered parenterally or orally are not allowed in patients with normal adrenal and pituitary function.
- Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent).
- Topical, nasal, and intra-articular corticosteroids are acceptable.
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- Known allergic reactions to gemcitabine
- Breast implant on the side of the body that will receive HIFU application
- Known history of HIV (Patients with HIV will be excluded because immunotherapy may impact the T cell profiling as part of the biologic correlates and the natural history of the disease)
- Known active Hepatitis B virus or Hepatitis C virus
- Other malignancy other than basal cell carcinoma of the skin or squamous cell carcinoma of the skin that is undergoing potentially curative therapy, ductal carcinoma in situ (DCIS), or in situ cervical cancer
- Active infection requiring other systemic therapy
- Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
- Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer
This study will test the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We will be testing the effects of each of these regimens on cells in the immune system. We hypothesize that the combination of focused ultrasound ablation and gemcitabine will decrease myeloid-derived suppressor cells and will increase T cell activity. We also hypothesize that focused ultrasound ablation and low-dose gemcitabine will be safe and will result in non-inferior surgical completion rates and tumor margin assessments.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Focused Ultrasound, Gemcitabine and Focused Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundDevice
Also called EchoPulse
Focused ultrasound will be applied to up to 2 breast lesions on day 8.
Gemcitabine and Focused UltrasoundOther
Also called Gemzar, EchoPulse
Gemcitabine (900 mg/m2) will be administered intravenously on day 1.Focused ultrasound will be applied to up to 2 breast lesions on day 8.
| Study group | Role | What they receive |
|---|---|---|
| Arm B: FUS | Experimental | Not described Receives: Device: Focused Ultrasound |
| Arm C: GEM/FUS | Experimental | Not described Receives: Other: Gemcitabine and Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any ≥ grade 3 adverse event
Adverse events as measured by CTCAE v5.0
Measured: Adverse events collected through 30 days after the last study treatment
Rate of participants experiencing a delay in surgery
Rate of participants experiencing a delay in surgery, beyond day 26
Measured: Through month 7 (Follow-up visit 2)
Rate of positive margins following surgery
Number of participants who have positive tumor margins at the time of surgery
Measured: Day 22
Secondary outcomes (6)
The effect of the treatments on myeloid-derived suppressor cells (MDSC) and CD8+ T cells in the tumor microenvironment
MDSC/CD8 ratio in the tumor
Measured: Day 22
The effect of the treatments on circulating activated T cells
Proportion of activated T cells in the blood
Measured: Measured through 30 days after the last active treatment visit
The effects of the treatments on dendritic cells in the tumor microenvironment
Dendritic cell maturation in the tumor; we will stain cells using panels of markers for maturation and use multi-spectral immunohistochemistry and/or flow cytometry to characterize the dendritic cell populations.
Measured: Day 22
Patient satisfaction with treatment regimen and surgery
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) will be used to assess patient satisfaction with the treatment regimen and surgery; graded on a scale from 0 to 4 and scoring outcomes vary depending on the question that is being asked.
Measured: through month 7
Patient and physician reported results on cosmesis
Harvard /NSABP/RTOG Breast Cosmesis Grading Scale will be used to assess cosmesis; graded is on a scale of 1 to 4 with a higher score indicating a poorer outcome.
Measured: through month 7
Residual cancer burden
MD Anderson Residual Cancer Burden Calculator
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start27 Jan 2022
- Primary completionSep 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Dillon, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Dillon, MD, University of Virginia
- Investigators
- Patrick Dillon, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796220
- Sponsor's protocol ID
- 200277
- Acronym
- Breast 54
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04796220
- Acronym / sponsor ID
- Breast 54 / 200277
- Conditions
- Breast Cancer, Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Patrick Dillon, MDUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Mar 2021 (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 study will test the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We will be testing the effects of each of these regimens on cells in the immune system. We hypothesize that the combination of focused ultrasound ablation and gemcitabine will decrease myeloid-derived suppressor cells and will increase T cell activity. We also hypothesize that focused ultrasound ablation and low-dose gemcitabine will be safe and will result in non-inferior surgical completion rates and tumor margin assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B: FUS | Experimental | Device: Focused Ultrasound |
| Arm C: GEM/FUS | Experimental | Other: Gemcitabine and Focused Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Disease Status
- A targetable portion of the tumor must be ≥ 5mm from the skin
- The rib cage should not be in the prefocal ultrasound path or behind the target area of the lesion (minimum distance from the posterior aspect of the target area to rib cage must be at least 10 mm).
- Participants must have at least one high-risk feature of breast cancer (tumor size and nodal status may be measured by mammogram, MRI, US, CT, or calipers):
- Triple negative breast cancer with Tumor size ≥10mm
Key exclusion criteria (14 listed)
- Received other treatment (standard or investigational) for their current breast cancer.
- Pregnant or lactating
- Diagnosis of immunodeficiency or receiving systemic steroid therapy within 7 days prior to enrollment with the following exceptions:
- Known allergic reactions to gemcitabine
- Breast implant on the side of the body that will receive HIFU application
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 |
|---|---|---|
| Focused UltrasoundAlso: EchoPulseFocused ultrasound will be applied to up to 2 breast lesions on day 8. | Device | Arm B: FUS |
| Gemcitabine and Focused UltrasoundAlso: Gemzar, EchoPulseGemcitabine (900 mg/m2) will be administered intravenously on day 1.Focused ultrasound will be applied to up to 2 breast lesions on day 8. | Other | Arm C: GEM/FUS |
Primary outcome
Number of participants with any ≥ grade 3 adverse event
Time frame: Adverse events collected through 30 days after the last study treatment
Adverse events as measured by CTCAE v5.0
Rate of participants experiencing a delay in surgery
Time frame: Through month 7 (Follow-up visit 2)
Rate of participants experiencing a delay in surgery, beyond day 26
Rate of positive margins following surgery
Time frame: Day 22
Number of participants who have positive tumor margins at the time of surgery
6 secondary outcomes
The effect of the treatments on myeloid-derived suppressor cells (MDSC) and CD8+ T cells in the tumor microenvironment
Time frame: Day 22
The effect of the treatments on circulating activated T cells
Time frame: Measured through 30 days after the last active treatment visit
The effects of the treatments on dendritic cells in the tumor microenvironment
Time frame: Day 22
Patient satisfaction with treatment regimen and surgery
Time frame: through month 7
Patient and physician reported results on cosmesis
Time frame: through month 7
Residual cancer burden
Time frame: Day 22
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 16 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. This study is not recruiting at the moment.
Patrick Dillon, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Focused Ultrasound and Gemcitabine and Focused Ultrasound in people with Breast Cancer and Breast Neoplasms, run by Patrick Dillon, MD 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 21 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 16 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Number of participants with any ≥ grade 3 adverse event (time frame: Adverse events collected through 30 days after the last study treatment). The study lists 3 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 16 Jun 2026.