Trial Outcomes & Findings for 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 (NCT NCT05198843)

NCT ID: NCT05198843

Last Updated: 2025-10-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-10-03

Participant Flow

Recruitment Period: Nov 1, 2022 to Dec 19, 2023. All recruitment was done at The University of Texas MD Anderson Cancer Center. The study was closed due to poor accrual.

One patient was enrolled and treated. One patient was not enrolled due to a screening failure.

Participant milestones

Participant milestones
Measure	Treatment (EPA, Dasatinib) Participants receive EPA \& dasatinib in each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (EPA, Dasatinib) Participants receive EPA \& dasatinib in each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Lack of Efficacy	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (EPA, Dasatinib) n=1 Participants Participants receive EPA \& dasatinib in each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 years

Population: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint.

Will be the proportion of the patients with static disease (SD) \>= 24 weeks, complete response (CR), and partial response (PR). CBR will be estimated along with a 95% exact confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1 year

Population: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint.

Defined as the rate of patients without the progression of disease or loss to follow-up at 1 year after initiating the EPA and dasatinib combination therapy. Will be estimated using the methods of Kaplan and Meier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years

Population: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed.

Defined as the survival rate at 2 years after initiating the EPA and dasatinib combination therapy. Will be estimated using the methods of Kaplan and Meier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After cycle 2 (1 cycle = 28 days)

Population: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint.

Tumor apoptosis will be measured by using the Luminex Apoptosis multiplex immunoassay panel (cleaved caspase-3) as well as TdT-Mediated dUTP Nick End Labeling (TUNEL) assay.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (EPA, Dasatinib)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (EPA, Dasatinib) n=1 participants at risk Participants receive EPA \& dasatinib in each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Pleural effusion	100.0% 1/1 • Number of events 1 • from the start date of treatment until 30 days after the last dose of study drug, approximately 2 months. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • Number of events 1 • from the start date of treatment until 30 days after the last dose of study drug, approximately 2 months. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • from the start date of treatment until 30 days after the last dose of study drug, approximately 2 months. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.
Investigations Weight gain	100.0% 1/1 • Number of events 1 • from the start date of treatment until 30 days after the last dose of study drug, approximately 2 months. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypomagnesemia	100.0% 1/1 • Number of events 1 • from the start date of treatment until 30 days after the last dose of study drug, approximately 2 months. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.

Additional Information

Dr. Rachel Layman

University of Texas M D Anderson Cancer Center

Phone: (713) 745-8401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60