Focused Ultrasound and Gemcitabine in Breast Cancer

NCT ID: NCT04796220

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2030-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B: FUS

Group Type: EXPERIMENTAL

Focused Ultrasound

Intervention Type: DEVICE

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

Arm C: GEM/FUS

Group Type: EXPERIMENTAL

Gemcitabine and Focused Ultrasound

Intervention Type: 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.

Interventions

Focused Ultrasound

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

Intervention Type: DEVICE

Gemcitabine and Focused Ultrasound

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.

Intervention Type: OTHER

Other Intervention Names

EchoPulse; Gemzar, EchoPulse

Eligibility Criteria

Inclusion Criteria

• 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
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, ≥ 18 years
• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
• ECOG performance status of 0-2
• Adequate organ function
• Agreement to adhere to lifestyle considerations throughout the study duration

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patrick Dillon, MD

OTHER

Sponsor Role: lead

Responsible Party

Patrick Dillon, MD

Associate Professor, Department of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Dillon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Olena Glushakova, MS

Role: CONTACT

oyg2n@hscmail.mcc.virginia.edu

434-409-6206

Facility Contacts

Olena Glushakova

Role: primary

mailto:OYG2N@hscmail.mcc.virginia.edu

434-409-6206

Other Identifiers

200277

Identifier Type: -

Identifier Source: org_study_id