- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796220
Focused Ultrasound and Gemcitabine in Breast Cancer (Breast 54)
April 17, 2024 updated by: Patrick Dillon, MD
Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olena Glushakova, MS
- Phone Number: 434-409-6206
- Email: oyg2n@hscmail.mcc.virginia.edu
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia
-
Contact:
- Olena Glushakova
- Phone Number: 434-409-6206
- Email: mailto:OYG2N@hscmail.mcc.virginia.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Disease Status
- Patients must have histologically confirmed, newly diagnosed breast cancer, stage 1-3
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: GEM
|
Gemcitabine (900 mg/m2) will be administered intravenously on day 1.
Other Names:
|
Experimental: Arm B: FUS
|
Focused ultrasound will be applied to up to 2 breast lesions on day 8.
Other Names:
|
Experimental: Arm C: GEM/FUS
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with any ≥ grade 3 adverse event
Time Frame: Adverse events collected through 30 days after the last study treatment
|
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
Time Frame: Through month 7 (Follow-up visit 2)
|
Rate of participants experiencing a delay in surgery, beyond day 26
|
Through month 7 (Follow-up visit 2)
|
Rate of positive margins following surgery
Time Frame: Day 22
|
Number of participants who have positive tumor margins at the time of surgery
|
Day 22
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of the treatments on myeloid-derived suppressor cells (MDSC) and CD8+ T cells in the tumor microenvironment
Time Frame: Day 22
|
MDSC/CD8 ratio in the tumor
|
Day 22
|
The effect of the treatments on circulating activated T cells
Time Frame: Measured through 30 days after the last active treatment visit
|
Proportion of activated T cells in the blood
|
Measured through 30 days after the last active treatment visit
|
The effects of the treatments on dendritic cells in the tumor microenvironment
Time Frame: Day 22
|
Dendritic cell maturation in the tumor; we will stain cells using panels of markers for maturation and use multi-spectral immunohistochemistry and/or flow cytometry to characterize the dendritic cell populations.
|
Day 22
|
Patient satisfaction with treatment regimen and surgery
Time Frame: through month 7
|
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) will be used to assess patient satisfaction with the treatment regimen and surgery; graded on a scale from 0 to 4 and scoring outcomes vary depending on the question that is being asked.
|
through month 7
|
Patient and physician reported results on cosmesis
Time Frame: through month 7
|
Harvard /NSABP/RTOG Breast Cosmesis Grading Scale will be used to assess cosmesis; graded is on a scale of 1 to 4 with a higher score indicating a poorer outcome.
|
through month 7
|
Residual cancer burden
Time Frame: Day 22
|
MD Anderson Residual Cancer Burden Calculator
|
Day 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrick Dillon, MD, University of Virginia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2022
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 12, 2021
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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