Focused Ultrasound and Gemcitabine in Breast Cancer

NCT04796220 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 200277
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

• Number of participants with any ≥ grade 3 adverse event

  Adverse events as measured by CTCAE v5.0

  Adverse events collected through 30 days after the last study treatment

• Rate of participants experiencing a delay in surgery

  Rate of participants experiencing a delay in surgery, beyond day 26

  Through month 7 (Follow-up visit 2)

• Rate of positive margins following surgery

  Number of participants who have positive tumor margins at the time of surgery

  Day 22

Secondary Outcomes (6)

• The effect of the treatments on myeloid-derived suppressor cells (MDSC) and CD8+ T cells in the tumor microenvironment

  Day 22

• The effect of the treatments on circulating activated T cells

  Measured through 30 days after the last active treatment visit

• The effects of the treatments on dendritic cells in the tumor microenvironment

  Day 22

• Patient satisfaction with treatment regimen and surgery

  through month 7

• Patient and physician reported results on cosmesis

  through month 7

Study Arms (2)

Arm B: FUS

EXPERIMENTAL

Device: Focused Ultrasound

Arm C: GEM/FUS

EXPERIMENTAL

Other: Gemcitabine and Focused Ultrasound

Interventions

Focused Ultrasound DEVICE

Focused ultrasound will be applied to up to 2 breast lesions on day 8.

Also known as: EchoPulse

Arm B: FUS

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.

Also known as: Gemzar, EchoPulse

Arm C: GEM/FUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Accessible is defined as the following:
• 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).
• Participants must have at least one high-risk feature of breast cancer (tumor size and nodal status may be measured by mammogram, MRI, US, CT, or calipers):
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patrick Dillon, MD: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Patrick Dillon, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olena Glushakova, MS

CONTACT

434-409-6206; oyg2n@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: January 27, 2022
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)