Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body

NCT05198843 | Terminated Phase 1 Results FDA Drug

• 4 other identifiers: NCI-2022-0000410480UM1CA1866882022-0246
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ib/II tests the safety, side effects, and best dose of icosapent ethyl in combination with dasatinib and whether they work to shrink tumors in patients with triple-negative inflammatory breast cancer that has spread to other places in the body (metastatic). Triple-negative inflammatory breast cancer is a type of inflammatory breast cancer in which the tumor cells do not have estrogen receptors, progesterone receptors, or large amounts of HER2/neu protein on their surface. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Icosapent ethyl is an omega-3 fatty acid and in a class of medications called antilipemic or lipid-regulating agents. It may decrease the amount of triglycerides and other fats made in the liver. Preclinical studies have suggested that it may reduce the growth of triple negative inflammatory breast cancer cells. Combination therapy with dasatinib and icosapent ethyl may help shrink tumors in patients with triple-negative inflammatory breast cancer.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Inflammatory Carcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) for Dasatinib and Icosapent Ethyl (EPA) Combination Therapy (Phase 1b)

  MTD is selected based on isotonic regression. Specifically, the dose is selected as the MTD for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level is selected when the isotonic estimate is lower than the target toxicity rate; the lower dose level is selected when the isotonic estimate is greater than or equal to the target toxicity rate.

  Up to 2 years

• Overall Response Rate (ORR) of Dasatinib and EPA Combination Therapy (Phase 2)

  the percentage of patients with a best overall response of CR (complete response) or PR (partial response)

  Up to 2 years

Secondary Outcomes (4)

• Clinical Benefit Rate (CBR)

  Up to 2 years

• Progression-free Survival

  At 1 year

• Overall Survival

  At 2 years

• Induction of Tumor Apoptosis

  After cycle 2 (1 cycle = 28 days)

Study Arms (1)

Treatment (icosapent ethyl, dasatinib)

EXPERIMENTAL

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.

Drug: Dasatinib; Dietary Supplement: Icosapent Ethyl

Interventions

Dasatinib DRUG

Given PO

Also known as: BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel

Treatment (icosapent ethyl, dasatinib)

Icosapent Ethyl DIETARY_SUPPLEMENT

Given PO

Also known as: (all-Z)-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester, AMR 101, AMR101, Cis-Eicosapentaenoic Acid Ethyl Ester, Ethyl Icosapentate, Vascepa

Treatment (icosapent ethyl, dasatinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed mTN-IBC. TNBC is defined as:
• \< 10% estrogen receptor and progesterone receptor expression by immunohistochemistry (IHC)
• Negative or 1+ for HER2 by IHC or negative by fluorescent in situ hybridization based on American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guideline
• Patients must have had or currently have a clinical diagnosis of inflammatory breast carcinoma (IBC) according to the IBC-specific clinical manifestation as determined by a multidisciplinary team
• Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for the phase 2 component of the study. Measurable disease is not a criterion for eligibility for the phase 1 component of the study
• Patients must have minimum of one standard regimen exposure in a metastatic setting
• Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of dasatinib in combination with EPA in patients \< 18 years of age, children are excluded from this study
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
• Absolute neutrophil count \>= 1,500/mcL
• Platelets \>= 100,000/mcL
• Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN
• Creatinine =\< 1.5 x institutional ULN
• Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2
• Patients with distant metastasis and/or local recurrence accessible for biopsy. Metastasis to brain, lung, and bone will be considered not accessible for safety reasons

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 2 weeks (3 weeks for nitrosoureas or mitomycin C) prior to entering the study
• Patients who are receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib or icosapent ethyl or any of its components (tocopherol, gelatin, glycerin, maltitol, and sorbitol) or other agents used in study
• Patients who have not recovered from adverse events due to prior anti-cancer therapies, (i.e., have residual toxicities \> grade 1) with the exception of alopecia
• Patients with known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they are stable, and have no evidence of new or enlarging brain metastases for at least 3 months, and are not using steroids for at least 7 days prior to trial treatment
• Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
• Patients with a history of (non-infectious) pneumonitis that required steroids or has a current diagnosis of pneumonitis
• Patients with an active infection requiring systemic therapy
• Patients with an allergy to fish, shellfish, or omega-3 unsaturated fatty acid
• Patients who received a live vaccine within 30 days prior to the first dose of trial treatment
• Patients receiving concurrent anti-cancer therapy for metastatic disease
• Patients with uncontrolled intercurrent illness judged by the investigator to be unsafe for trial participation
• Pregnant women are excluded from this study because dasatinib is a protein tyrosine kinase (PTK) inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dasatinib, breastfeeding should be discontinued if the mother is treated dasatinib. These potential risks may also apply to other agents used in this study
• Patients with severe hypertriglyceridemia (\> 300 mg/dL-500 mg/dL) are at an unknown risk of developing pancreatitis following icosapent ethyl treatment
• Patients with diabetes who are being treated with insulin. Patients with oral medication and showing stable glycosylated hemoglobin (HbA1c) \< 7% for the last three months will be eligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Dasatinib; eicosapentaenoic acid ethyl ester; eicosapentaenoic acid ethanolamide

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Rachel Layman
• Organization: University of Texas M D Anderson Cancer Center

RLayman@mdanderson.org

(713) 745-8401

Study Officials

• Rachel M. Layman

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 20, 2022
• Study Start: November 8, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 20, 2023
• Last Updated: October 3, 2025
• Results First Posted: September 4, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)