Focused Ultrasound and Gemcitabine in Breast Cancer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor: Patrick Dillon, MD
Study ID: NCT04796220
Phase: PHASE1
Status: Recruiting

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Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Focused Ultrasound — DEVICE
Focused ultrasound will be applied to up to 2 breast lesions on day 8.
Gemcitabine and Focused Ultrasound — OTHER
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 Details

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.