Actively Recruiting
Focused Ultrasound and Gemcitabine in Breast Cancer
Led by Patrick Dillon, MD · Updated on 2025-07-03
32
Participants Needed
1
Research Sites
418 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Focused Ultrasound and Gemcitabine in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed new diagnosis of breast cancer, stage 1-3, or localized recurrent disease suitable for complete surgical removal
- Cancer may have any receptor status (estrogen, progesterone, HER2)
- Lesion accessible to focused ultrasound ablation: tumor at least 5 mm from skin and rib cage at least 10 mm behind lesion
- At least one high-risk breast cancer feature such as triple negative with tumor size 10 mm, lymph node involvement, or specified tumor sizes with receptor status
- Willing and able to provide written consent
- Willing to comply with all study procedures and available for study duration
- Male or female, aged 18 years or older
- Willing to provide tissue from a new biopsy of tumor lesion
- ECOG performance status 0-2
- Adequate organ function
- Agree to lifestyle considerations during study
You will not qualify if you...
- Prior treatment (standard or investigational) for current breast cancer
- Pregnant or lactating
- Immunodeficiency or systemic steroid therapy within 7 days prior to enrollment (with specific exceptions)
- Known allergy to gemcitabine
- Breast implant on the side receiving focused ultrasound
- Known HIV infection
- Active Hepatitis B or C infection
- Other malignancy except certain skin cancers or in situ cervical cancer undergoing curative treatment
- Active infection needing systemic therapy
- Medical or psychological conditions preventing participation
- Any physical exam findings that preclude study involvement
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
O
Olena Glushakova, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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