Trial · NCT05198843
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, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2024-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05198843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05198843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT05198843
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Inflammatory Carcinoma
- Interventions
- Dasatinib, Icosapent Ethyl
- First posted
- 2022-01-20
- Last updated
- 2025-10-03
- Results first posted
- 2024-09-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) for Dasatinib and Icosapent Ethyl (EPA) Combination Therapy (Phase 1b) | Up to 2 years | 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. |
| Primary | Overall Response Rate (ORR) of Dasatinib and EPA Combination Therapy (Phase 2) | Up to 2 years | the percentage of patients with a best overall response of CR (complete response) or PR (partial response) |
| Secondary | Clinical Benefit Rate (CBR) | Up to 2 years | 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. |
| Secondary | Progression-free Survival | At 1 year | 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. |
| Secondary | Overall Survival | At 2 years | 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. |
| Secondary | Induction of Tumor Apoptosis | After cycle 2 (1 cycle = 28 days) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) for Dasatinib and Icosapent Ethyl (EPA) Combination Therapy (Phase 1b) | Up to 2 years | No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint. | ||
| PRIMARY | Overall Response Rate (ORR) of Dasatinib and EPA Combination Therapy (Phase 2) | Up to 2 years | No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint. | ||
| SECONDARY | Clinical Benefit Rate (CBR) | Up to 2 years | No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint. | ||
| SECONDARY | Progression-free Survival | At 1 year | No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint. | ||
| SECONDARY | Overall Survival | At 2 years | No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed. | ||
| SECONDARY | Induction of Tumor Apoptosis | After cycle 2 (1 cycle = 28 days) | No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (EPA, Dasatinib) | 1 | |
| Overall Study | COMPLETED | Treatment (EPA, Dasatinib) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (EPA, Dasatinib) | 1 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Treatment (EPA, Dasatinib) | 1 | 1 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (EPA, Dasatinib) | 1 | 1 | 1 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Treatment (EPA, Dasatinib) | 1 | 1 | 1 |
| other | Weight gain | Investigations | Treatment (EPA, Dasatinib) | 1 | 1 | 1 |
| other | Hypomagnesemia | Metabolism and nutrition disorders | Treatment (EPA, Dasatinib) | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (EPA, Dasatinib) | 0 | 1 |
| Total, other adverse events | Treatment (EPA, Dasatinib) | 1 | 1 |
| Total, serious adverse events | Treatment (EPA, Dasatinib) | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186688 | Texas EXperimental Cancer Therapeutics Network - TEX CTN | MERIC-BERNSTAM, FUNDA; SARANTOPOULOS, JOHN; YAO, JAMES C | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05198843
GET https://conductscience.org/api/trials/v1/NCT05198843/registered