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Tyrosine Kinase Inhibitor
Omega-3 Based Therapy for Triple-Negative Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Naoto T Ueno
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of combining two drugs, icosapent ethyl and dasatinib, to treat triple-negative inflammatory breast cancer.
Who is the study for?
This trial is for adults with metastatic triple-negative inflammatory breast cancer who've had at least one standard treatment. They must have certain normal organ function tests, no severe heart conditions or active infections, and can't be pregnant. People with a history of severe allergies to the drugs' components or those on certain other treatments are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of dasatinib, a tyrosine kinase inhibitor that blocks proteins involved in cancer cell growth, and icosapent ethyl, an omega-3 fatty acid that may reduce liver fat production and slow cancer growth. The goal is to find the safest dose that can shrink tumors.See study design
What are the potential side effects?
Possible side effects include digestive issues due to omega-3 acids like fishy aftertaste or upset stomach; dasatinib might cause fluid retention, muscle pain, skin rash or impact blood counts leading to increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) for dasatinib and icosapent ethyl (EPA) combination therapy (Phase 1b)
Overall response rate (ORR) of dasatinib and EPA combination therapy (Phase 2)
Secondary outcome measures
Clinical benefit rate (CBR)
Induction of tumor apoptosis
Overall survival
+1 moreOther outcome measures
Change in Ki67
Change in cholesterol homeostasis and tumor membrane rigidity
Change in expression of EphA2
+1 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Atrial fibrillation
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Typhlitis
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (icosapent ethyl, dasatinib)Experimental Treatment2 Interventions
Patients receive icosapent ethyl PO BID and dasatinib PO QD in each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,546 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Naoto T UenoPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
8 Previous Clinical Trials
2,524 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious heart condition.You have already been treated with at least one standard medication for your cancer that has spread.If you could become pregnant, you have to have a negative pregnancy test.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit.You have a serious autoimmune disease that has required strong medication in the past 3 months.You have had allergic reactions to medications similar to dasatinib or icosapent ethyl.Participants must have confirmed metastatic triple-negative breast cancer.You are able to perform daily activities without assistance or with a little help.Your kidneys are working well, unless there is proof that the study drug can be used safely with lower kidney function, but not lower than a certain value.If you have chronic hepatitis B virus (HBV) infection, the amount of virus in your blood must be very low due to treatment.You have cancer that has spread to your brain or spinal cord.You have difficulty swallowing and keeping down dasatinib and icosapent ethyl tablets.You are still experiencing side effects from previous cancer treatments, except for hair loss.You have had a lung condition called pneumonitis that needed steroids, or you currently have pneumonitis.You have an infection that needs medicine to treat it.You have an allergy to fish, shellfish, or omega-3 unsaturated fatty acid.You are currently receiving treatment for cancer that has spread to other parts of your body.You have very high levels of triglycerides in your blood.You have diabetes and are taking insulin.You are taking medications or substances that strongly affect CYP3A4.Patients must have a way to measure their disease according to specific guidelines for the study.Your white blood cell count is at least 1,500 per microliter.Your platelet count is at least 100,000 per microliter.Your total bilirubin level should be within a certain range that is considered normal at the hospital.If you have HIV and are taking medicine that keeps your virus under control, you can join the trial.If you had hepatitis C in the past, you must have been treated and cured.You have cancer that has spread far away from the original tumor, or the cancer has come back in a place that can be biopsied.You have been diagnosed with or currently have inflammatory breast carcinoma (IBC) confirmed by a team of different medical specialists.You are currently taking blood thinners or medications that prevent blood clots.Your creatinine levels are within a certain range determined by the hospital.You can still join the trial if you have had another type of cancer in the past, as long as it won't affect the study's ability to measure the safety and effectiveness of the new treatment.You have a history of heart problems or are currently experiencing heart-related symptoms.We don't know how dasatinib might affect a developing baby.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (icosapent ethyl, dasatinib)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively enrolled in this experimental research endeavor?
"Yes, the most recent information on clinicaltrials.gov confirms that this medical study is actively accepting participants. This trial was first published on March 25th 2022 and was last updated September 3rd 2022. It requires 18 patients to be recruited across two sites for completion."
Answered by AI
Are there any open openings for this medical study?
"Affirmative, per information on clinicaltrials.gov this trial is currently seeking participants. This medical study was first published on March 25th 2022 and has been revised as of September 3rd 2022. The trial requires 18 individuals from 2 distinct sites to partake in the experiment."
Answered by AI
What aims does this research endeavor seek to achieve?
"This clinical trial has a two year timeframe with the primary aim of assessing overall response rate (ORR) (Phase 2). Secondary objectives include inducing tumor apoptosis, measuring progression-free survival, and calculating overall survival. To measure these goals Luminex Apoptosis multiplex immunoassay panel (cleaved caspase-3) as well as TdT-Mediated dUTP Nick End Labeling (TUNEL) assay will be employed alongside Kaplan and Meier methods."
Answered by AI
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