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OncoMatch/Clinical Trials/NCT04796220

Focused Ultrasound and Gemcitabine in Breast Cancer

Is NCT04796220 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Focused Ultrasound for breast cancer.

Phase 1RecruitingPatrick Dillon, MDNCT04796220Data as of May 2026

Treatment: Focused UltrasoundThis 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Allowed: HER2 (ERBB2) negative

Allowed: HER2 (ERBB2) positive

Allowed: ESR1 negative

Allowed: ESR1 positive

Allowed: PR (PGR) negative

Allowed: PR (PGR) positive

Disease stage

Required: Stage I, II, III

stage 1-3 disease and be appropriate surgical candidates for complete resection

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any treatment for current breast cancer

Received other treatment (standard or investigational) for their current breast cancer.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Virginia · Charlottesville, Virginia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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