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Focused Ultrasound + Gemcitabine for Breast Cancer (Breast 54 Trial)
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.
Breast 54 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBreast 54 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Breast 54 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm C: GEM/FUS
- Group 2: Arm A: GEM
- Group 3: Arm B: FUS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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"
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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