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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.
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through month 7 (follow-up visit 2)
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have HIV.
Select...
I have an active Hepatitis B or C infection.
Select...
I am currently being treated for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through month 7 (follow-up visit 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through month 7 (follow-up visit 2)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with any ≥ grade 3 adverse event
Rate of participants experiencing a delay in surgery
Rate of positive margins following surgery
Secondary study objectives
Patient and physician reported results on cosmesis
Patient satisfaction with treatment regimen and surgery
Residual cancer burden
+3 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
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%
Dyspnoea
1%
Cerebral infarction
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1920
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high doses of steroids or have an immune system problem recently.You have a medical or mental health condition that prevents you from taking part in the study.I am willing to undergo a biopsy to provide a tissue sample.My organs are working well.I have a tumor in my breast, chest wall, or armpit area that can be targeted with focused ultrasound.You have had allergic reactions to gemcitabine in the past.I am willing to undergo a biopsy to provide a tissue sample from my tumor.I have been newly diagnosed with stage 1-3 breast cancer.I am 18 years old or older.I do not have HIV.I have an active Hepatitis B or C infection.My cancer is considered high-risk based on genetic testing.I have skin cancer or early-stage breast or cervical cancer that is being treated.My cancer's receptor status does not limit my eligibility.I have a tumor in my breast, chest wall, or armpit that can be reached with ultrasound treatment.I am able to care for myself and perform daily activities.I have received other treatments for my current breast cancer.My condition is actively showing symptoms or signs.The subject has agreed to follow all study procedures and is available for the duration of the study.You have a breast implant on the same side where the treatment will be applied.I am currently being treated for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C: GEM/FUS
- Group 2: Arm A: GEM
- Group 3: Arm B: FUS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.