TerminatedPhase 1/2

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

Stopped: Other - Poor accrual

United States1 participantsStarted 2022-11-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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…

What they're measuring

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

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

Trial details

NCT IDNCT05198843

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-12-19

Results submitted2024-04-24