RecruitingPhase 1NCT04796220

Focused Ultrasound and Gemcitabine in Breast Cancer

Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer

Sponsor

Patrick Dillon, MD

Enrollment

32 participants

Start Date

Jan 27, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether focused ultrasound — a non-invasive technique that delivers high-intensity sound waves directly to a tumor — combined with gemcitabine (a chemotherapy drug) can boost the immune system's response to breast cancer before surgery. The goal is to see if this combination can shrink the tumor and trigger lasting anti-cancer immunity. **You may be eligible if...** - You have a newly confirmed breast cancer diagnosis at stage 1–3 and are a candidate for surgery, OR - You have recurrent breast cancer confined to the breast, chest wall, or armpit and are a surgery candidate - Any hormone receptor status (ER, PR, HER2) is accepted - High-risk disease on genomic profiling (if profiling was done) **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic) - You are not a surgical candidate - You have other conditions that would make focused ultrasound or chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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