NCT04796220
Focused Ultrasound and Gemcitabine in Breast Cancer
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentPatrick Dillon, MDInvestigator-initiated
~32 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Focused UltrasoundGemcitabine and Focused Ultrasound
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with any ≥ grade 3 adverse event
Measured over Adverse events collected through 30 days after the last study treatment
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Patrick Dillon, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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).
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
Exclusion
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.
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
What this trial measures
- Number of participants with any ≥ grade 3 adverse eventAdverse 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 surgeryThrough month 7 (Follow-up visit 2)
Rate of participants experiencing a delay in surgery, beyond day 26
- Rate of positive margins following surgeryDay 22
Number of participants who have positive tumor margins at the time of surgery