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Procedure

Focused Ultrasound + Gemcitabine for Breast Cancer (Breast 54 Trial)

Phase 1
Recruiting
Research Sponsored by Patrick Dillon, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
Patients must have a lesion in the breast/chest wall/axilla that is accessible to focused ultrasound ablation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through month 7 (follow-up visit 2)
Awards & highlights

Breast 54 Trial Summary

This trial will test whether focused ultrasound ablation, low-dose gemcitabine, or a combination of the two can help early-stage breast cancer patients by affecting cells in the immune system. The hypothesis is that the combination of the two will be more effective and have fewer negative side effects than either treatment alone.

Who is the study for?
This trial is for adults with newly diagnosed breast cancer stages 1-3, regardless of hormone receptor status. Participants must have a lesion accessible to focused ultrasound and be willing to provide tissue samples. They should have good performance status (ECOG 0-2) and adequate organ function. Exclusions include those with breast implants on the treatment side, prior treatments for current cancer, pregnancy, certain steroid therapies or immunodeficiencies, known allergies to gemcitabine, other active cancers or infections.Check my eligibility
What is being tested?
The study examines the safety and immune system effects of three regimens: focused ultrasound ablation alone, low-dose gemcitabine chemotherapy alone, and their combination in early-stage breast cancer patients. It aims to see if these treatments can reduce suppressor cells that hinder immunity while boosting T cell activity without compromising surgery outcomes.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy like nausea, fatigue, lowered blood counts leading to increased infection risk; skin irritation from ultrasound; plus any unforeseen complications related to combining these two treatments.

Breast 54 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to undergo a biopsy to provide a tissue sample.
Select...
I have a tumor in my breast, chest wall, or armpit area that can be targeted with focused ultrasound.
Select...
I am willing to undergo a biopsy to provide a tissue sample from my tumor.
Select...
I have been newly diagnosed with stage 1-3 breast cancer.
Select...
I have a tumor in my breast, chest wall, or armpit that can be reached with ultrasound treatment.
Select...
I am able to care for myself and perform daily activities.

Breast 54 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through month 7 (follow-up visit 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through month 7 (follow-up visit 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with any ≥ grade 3 adverse event
Rate of participants experiencing a delay in surgery
Rate of positive margins following surgery
Secondary outcome measures
Patient and physician reported results on cosmesis
Patient satisfaction with treatment regimen and surgery
Residual cancer burden
+3 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Breast 54 Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: GEM/FUSExperimental Treatment1 Intervention
Group II: Arm B: FUSExperimental Treatment1 Intervention
Group III: Arm A: GEMExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Focused Ultrasound
2012
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Patrick Dillon, MDLead Sponsor
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Breast Cancer
13 Patients Enrolled for Breast Cancer

Media Library

Focused Ultrasound (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04796220 — Phase 1
Breast Cancer Research Study Groups: Arm C: GEM/FUS, Arm A: GEM, Arm B: FUS
Breast Cancer Clinical Trial 2023: Focused Ultrasound Highlights & Side Effects. Trial Name: NCT04796220 — Phase 1
Focused Ultrasound (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04796220 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What do researchers hope to discover or confirm through this clinical trial?

"The primary outcome of this study is the rate of participants experiencing a delay in surgery, which will be measured over a 30-day period. Secondary outcomes include the effect of the treatments on circulating activated T cells (defined as the proportion of activated T cells in the blood), patient and physician reported results on cosmesis (defined as Harvard /NSABP/RTOG Breast Cosmesis Grading Scale; graded on a scale of 1 to 4, with a higher score indicating a poorer outcome), and the effects of the treatments on dendritic cells in the tumor microenvironment (defined as dendritic cell maturation in the"

Answered by AI

What is Gemcitabine used to treat most frequently?

"Gemcitabine is an effective treatment for small cell lung cancer, head and neck carcinoma, pancreatic adenocarcinoma locally advanced, and cervical cancers."

Answered by AI

What is the precedent for Gemcitabine in medical research?

"At present, 464 different clinical trials are underway to investigate gemcitabine. Of these 137 are classified as phase 3 studies. The majority of these trials are taking place in Woolloongabba, Queensland, although there are 24699 total locations running such studies globally."

Answered by AI

Is this research project looking for new participants?

"That is correct. According to the clinicaltrials.gov listing, this trial was last updated on May 17th, 2022 and is still actively recruiting patients. They are looking for a total of 48 participants from 1 site."

Answered by AI

Are there long-term detriments to taking Gemcitabine?

"Given that this is a Phase 1 trial with limited data to support safety and efficacy, our team at Power has estimated the safety of Gemcitabine to be a 1."

Answered by AI

How many individuals are participating in this trial?

"The most recent information available on clinicaltrials.gov shows that this study is still actively seeking participants. The trial was originally posted on 1/27/2022, and the last update was on 5/17/2022. They are currently searching for 48 patients from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Michigan
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Focused Ultrasound and Gemcitabine in Breast Cancer
Patrick Dillon, MD 2022. "Focused Ultrasound and Gemcitabine in Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04796220.
All > Her 2 Positive Breast Cancer > Breast Cancer
~17 spots leftby Aug 2025
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