This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results 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 (NCT05198843), a na phase 1, phase 2 study. The primary outcome is Maximum Tolerated Dose (MTD) for Dasatinib and Icosapent Ethyl (EPA) Combination Therapy (Phase 1b).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05198843 |
| Phase | Phase 1, Phase 2 |
| Condition | Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Inflammatory Carcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic triple-negative inflammatory breast cancer were the intended population. The registry also lists anatomic stage IV breast cancer and metastatic triple-negative breast inflammatory carcinoma among the conditions. The brief description focuses on disease that has spread to other parts of the body.
Intervention
The treatment group was assigned icosapent ethyl by mouth twice daily and dasatinib by mouth once daily in each treatment cycle. Cycles were described as repeating every 28 days in the absence of disease progression or unacceptable toxicity.
Comparator
No comparator group is described. The study is listed as single-group, with allocation recorded as not applicable and no masking. It therefore does not provide a randomized, like-for-like comparison with another treatment or a control group.
Primary question
The primary endpoint asks for the maximum tolerated dose of the dasatinib and icosapent ethyl combination in phase Ib. The registry describes selecting that dose using isotonic regression and a target toxicity rate. It also describes safety and tumor response as broader study interests, but reports no efficacy data because the study was terminated early.
3. Trial Design
NCT05198843 is listed as a phase Ib/II, single-group study of icosapent ethyl with dasatinib. The registry records allocation as not applicable and masking as none. With no comparator group, the design is not a randomized comparison and cannot estimate a treatment contrast against a concurrent control.
The planned treatment was oral icosapent ethyl twice daily with oral dasatinib once daily. Treatment cycles were described as repeating every 28 days unless disease progression or unacceptable toxicity occurred. The primary endpoint applies to the phase Ib dose-finding part: maximum tolerated dose for the combination. The registry describes isotonic regression as the selection method.
Enrollment is recorded as 1. The study started on 2022-11-08, its primary completion date is listed as 2023-12-19, and its status is terminated. The registry states that no efficacy data were obtained because the study was terminated early, and that the outcome measure had zero total analyzed at the protocol-specified restaging timepoint. The record does not report a dose-selection result or an efficacy estimate.
The study description names clinical benefit rate, progression-free survival, overall survival, and induction of tumor apoptosis as secondary outcomes. Their presence as planned outcomes does not establish that they were analyzed. The registry lists no analysis records.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: One patient was enrolled and treated. One patient was not enrolled due to a screening failure.
Overall Study
| Stage | Treatment (EPA, Dasatinib) |
|---|---|
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Treatment (EPA, Dasatinib) |
|---|---|
| Lack of Efficacy | 1 |
Analysis population for the primary outcome, as defined in the registry: No efficacy data was obtained since the study was terminated early. Outcome Measure has zero total analyzed at the protocol specified restaging timepoint.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Treatment (EPA, Dasatinib) |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD) for Dasatinib and Icosapent Ethyl (EPA) Combination Therapy (Phase 1b), measured over Up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum tolerated dose of dasatinib and icosapent ethyl in the phase Ib part of the study. It is a dose-selection endpoint based on toxicity, not a direct measure of tumor response or survival. The registry says the selected dose is the dose level whose isotonic estimate of the toxicity rate is closest to the target toxicity rate.
In general, a dose-finding endpoint can help identify a dose for further study by relating dose levels to observed toxicity. Isotonic regression is a method for estimating a pattern under an ordering constraint: as dose levels increase, the estimated toxicity rates are constrained not to decrease. This can provide a structured estimate when observed rates across dose levels do not follow that pattern.
The registry also specifies how to resolve ties. If tied estimates are below the target toxicity rate, the higher dose level is selected; if they are equal to or above the target, the lower dose level is selected. The numerical target toxicity rate and the chosen dose are not reported in the registry record. The primary endpoint's timeframe is listed as up to 2 years, but the record does not provide an analyzed dose-selection result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry reports no efficacy data. It states that the study was terminated early and that zero participants were analyzed at the protocol-specified restaging timepoint. Consequently, the record does not provide an efficacy estimate for tumor response, clinical benefit, progression-free survival, overall survival, or tumor apoptosis. Those outcomes are named in the study record, but outcome names alone are not results.
The primary endpoint is a maximum tolerated dose, but no selected dose or isotonic toxicity estimates are reported. The endpoint description explains how a dose was intended to be selected; it does not show that a dose was selected or establish the toxicity profile of the combination. The target toxicity rate and dose-level results are also not reported in the registry record.
Enrollment is recorded as 1. That enrollment figure indicates the scale of the record, but it does not supply a basis for estimating efficacy or drawing stable conclusions about safety. In particular, the absence of analyzed efficacy data should not be reinterpreted as evidence of no tumor response. There is no reported response estimate to assess, and no comparison group against which a response could be contrasted.
The safety figures require a separate, narrow reading. The registry lists 0 serious adverse events among 1 at risk in the treatment group, 1 affected by other adverse events among 1 at risk, and 0 deaths. These are counts recorded for the group, not a comprehensive account of the types, timing, severity, or duration of events. No serious adverse-event terms are listed. The figures do not support broad conclusions about safety in the intended population.
The record's status is terminated, with no analysis records listed. The reason for termination beyond the statement that it occurred early, the timing and extent of treatment exposure, and details of any analysis population are not reported in the registry record. Taken together, the posted information documents a study design, a planned dose-selection rule, and limited safety counts, but not an interpretable efficacy result or a reported dose-selection outcome.
9. Statistical Methods Explained
What does isotonic regression do?
The registry names isotonic regression as the method for selecting the maximum tolerated dose. In general, isotonic regression estimates a sequence while imposing an order constraint. In dose-finding, that constraint can represent the expectation that estimated toxicity should not decrease as dose increases. The method can pool adjacent estimates when the observed pattern does not satisfy the ordering, producing a constrained sequence rather than treating each observed rate as unrelated.
The registry's stated decision rule is to select the dose whose isotonic estimate of toxicity is closest to the target toxicity rate. If there is a tie, it selects the higher dose level when the isotonic estimate is below the target and the lower dose level when the estimate is equal to or above the target. This rule explains the intended decision process; it is not itself evidence of the dose selected. The target toxicity rate, dose levels, observed toxicities, isotonic estimates, and selected dose are not reported in the registry record.
What can the single-group design establish?
The study is listed as single-group, with allocation not applicable and masking none. In general, a single-group study can describe outcomes observed among people receiving the intervention, but it cannot by itself estimate how those outcomes compare with what would have happened under a concurrent control treatment. Differences from an external or historical population would require additional information and assumptions; no such comparison is reported.
The absence of masking means the registry does not describe masking of treatment assignment. That design feature can matter when outcomes involve judgments or reporting, but the record does not give enough detail to assess how any potential influence was handled. No randomized control comparison is available to separate treatment-associated observations from other explanations.
How should the planning assumptions be read?
The study record includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of an observed effect. For time-to-event calculations, the stated quantity is total events; for other calculations, it is participants per arm. Those assumptions describe planning calculations, not this study's observed design, which is single-group.
The registry does not report an efficacy estimate: it says no efficacy data were obtained and records zero total analyzed at the protocol-specified restaging timepoint. Therefore, the planning assumptions should not be interpreted as observed power or as evidence that an effect was detected. No numerical effect fraction, resulting planning values, sample-size justification, or protocol-specific statistical plan is reported in the registry record. In general, planning calculations depend on their assumptions and do not convert an unavailable outcome into evidence.
What is the role of confidence intervals and significance tests?
In general, a confidence interval expresses the range of estimates compatible with the data and the method used to construct it. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates less precision. A significance test evaluates data against a specified null hypothesis and analysis plan. Neither device can supply an estimate when the outcome has no analyzed observations.
The registry lists zero analysis records and provides no efficacy estimate, confidence interval, or efficacy test result. The numerical target toxicity rate and dose-selection results are also absent. It is therefore not possible to assess the precision or statistical evidence for efficacy from this record. A missing estimate is not an estimate centered at no effect, and absence of a reported test result is not a nonsignificant finding.
Why can over-dispersion matter?
In general, over-dispersion occurs when variability in data exceeds what a statistical model assumes. If ignored, standard errors can be too small and intervals or tests can appear more certain than warranted. Whether over-dispersion is relevant depends on the outcome, model, and observed data. The registry record does not report an efficacy analysis, model diagnostics, or an analysis plan that would allow this issue to be evaluated for this study.
These methods explain the intended logic of dose selection and general principles of inference. They do not fill in unreported results. The registry does not provide the dose-level data or efficacy analyses needed to reproduce or evaluate a statistical result.
10. Multiplicity, Missing Data and Analysis Populations
The record names several secondary outcomes: clinical benefit rate, progression-free survival, overall survival, and induction of tumor apoptosis. It also lists six outcome measures, but gives no analysis records. Naming multiple outcomes raises a general multiplicity question: when several outcomes or tests are considered, a statistical plan may specify how to interpret the chance of false-positive findings across them. No multiplicity adjustment or strategy is reported in the registry record.
The primary endpoint is the phase Ib maximum tolerated dose, while the secondary outcomes address other clinical or biological measures. The registry provides no reported inferential analyses for these outcomes. It would therefore be inappropriate to infer that multiplicity was or was not controlled, or to treat any outcome as statistically significant.
For missing data and analysis populations, the record says no efficacy data were obtained because the study was terminated early and that zero total participants were analyzed at the protocol-specified restaging timepoint. It does not describe imputation, a missing-data model, reasons for unavailable outcomes at the individual level, or analysis-population definitions. The enrollment entry is 1, but the registry does not report a population-flow account or further detail about treatment exposure and follow-up. Those omissions limit interpretation; they do not establish why any individual outcome was unavailable beyond the stated early termination and lack of efficacy data.
In general, multiplicity and missing-data methods matter because they affect what an estimate and its uncertainty mean. Here, no reported efficacy analysis is available to evaluate under such methods. The registry also does not report whether any interim analyses were planned or performed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Treatment (EPA, Dasatinib) | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (EPA, Dasatinib) | 0 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment (EPA, Dasatinib) | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (EPA, Dasatinib) |
|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 1 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 1 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 1 |
| Weight gain | Investigations | 1 of 1 |
| Hypomagnesemia | Metabolism and nutrition disorders | 1 of 1 |
The registry records 0 serious adverse events among 1 at risk in the treatment group. It records 1 affected by other adverse events among 1 at risk, and 0 deaths. No serious adverse-event terms are listed. These figures should be read as the adverse-event counts recorded in the registry, not as a detailed narrative of all events or a complete account of exposure.
Serious and other adverse events are separate categories in the record. A count of 0 for serious events does not mean that no adverse events of any kind were recorded: the other-adverse-event count is 1. The registry does not report the event term, severity, timing, duration, relationship to treatment, or participant-level exposure details for that other event. The serious-event count also cannot establish the safety of the combination in the intended population, given the study's recorded enrollment of 1 and its early termination.
These data are descriptive counts. They are not a comparative safety estimate because no control group is described. The registry does not report enough detail to calculate or interpret an event rate over a defined exposure period.
12. What the Result Does, and Does Not, Mean
The record documents a planned phase Ib/II investigation of icosapent ethyl with dasatinib in metastatic triple-negative inflammatory breast cancer. Its primary phase Ib question concerned selection of a maximum tolerated dose using isotonic regression and a target toxicity rate. It also names several secondary outcomes, including clinical benefit and survival measures.
What the record does not establish is equally important. It reports no efficacy data, zero analyzed at the protocol-specified restaging timepoint, no analysis records, and no dose-selection result. It does not report an estimate of tumor response, clinical benefit, progression-free survival, overall survival, or tumor apoptosis. Therefore, the record cannot show whether those outcomes changed, how precisely they were estimated, or how they compared with another treatment.
The lack of efficacy data must not be read as a result showing no effect. It is an absence of an analyzed efficacy result, with early termination given as the reason no efficacy data were obtained. Likewise, the listed adverse-event counts are limited descriptive information, not a controlled assessment of safety. No comparator group is described, and no like-for-like treatment contrast can be estimated from this design.
The registry's design and endpoint description remain useful for understanding what investigators intended to study and how the primary dose decision was to be made. But planned methods and outcomes are not substitutes for observed results. The most defensible interpretation is that the registry documents a terminated study with recorded enrollment of 1, limited adverse-event counts, and no reported efficacy analysis or selected maximum tolerated dose. Broader conclusions about the treatment, disease outcomes, or safety are not supported by the posted results.
13. Why This Trial Matters Statistically
This study illustrates a distinction that is central to clinical-trial interpretation: a clearly described research question is not the same as an answer supported by analyzed outcomes. The registry specifies a dose-selection endpoint and an isotonic-regression rule, yet reports no selected dose. It also names efficacy outcomes but states that no efficacy data were obtained because the study was terminated early.
Statistically, this distinction prevents an absence of estimates from being mistaken for evidence of no effect. Estimation requires analyzed outcome information; precision requires enough information to quantify uncertainty. Neither can be recovered from the names of planned outcomes or from a method description alone. In this record, zero were analyzed at the protocol-specified restaging timepoint, so no efficacy estimate is reported.
The design also matters. A single-group study without a comparator can describe what is recorded within the treated group, but it cannot provide a randomized treatment contrast. The adverse-event counts are consequently descriptive and limited, rather than comparative evidence. The recorded enrollment of 1 further underlines how little information the record contains for broad inference.
For researchers and readers, the record offers a practical lesson in separating protocol intent, observed data, and statistical conclusions. A stated dose-selection algorithm is not a dose-selection result; planned secondary outcomes are not analyzed endpoints; and a safety count is not a comparative safety assessment. Careful interpretation depends on identifying which results are actually reported and which questions remain unanswered.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is the lack of analyzed efficacy data. The registry attributes this to early termination and reports zero analyzed at the protocol-specified restaging timepoint. It gives no efficacy estimates or uncertainty intervals, so the magnitude and precision of any efficacy outcome cannot be assessed.
The primary endpoint also lacks a reported result. Although the method for selecting the maximum tolerated dose is described, the registry does not report the target toxicity rate, dose levels, dose-level toxicity observations, isotonic estimates, or selected dose. The method description therefore cannot be used to reconstruct the decision.
The single-group design has no comparator, so it cannot estimate a randomized contrast. Masking is listed as none. Enrollment is recorded as 1, and the available safety entries are limited to counts without detailed event descriptions, timing, severity, or exposure information. No analysis records are listed.
Further details that would help assess interpretation—including the reason for termination beyond the statement that termination occurred early, analysis-population definitions, missing-data procedures, multiplicity strategy, and interim-analysis information—are not reported in the registry record. No sample-size justification or protocol-specific statistical plan is reported there either. These limitations restrict what can be concluded from the record; they do not determine what unreported results might have been.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 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.
- Registry record last updated 2025-10-03; status last verified 2025-09.
- Results first posted 2024-09-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05198843 is a phase Ib/II, single-group study of icosapent ethyl and dasatinib for metastatic triple-negative inflammatory breast cancer. The planned regimen was icosapent ethyl by mouth twice daily and dasatinib by mouth once daily in repeating 28-day cycles. The primary phase Ib endpoint was maximum tolerated dose, with selection described using isotonic regression.
The registry records enrollment as 1, status as terminated, and no masking. It reports no efficacy data because the study was terminated early and records zero analyzed at the protocol-specified restaging timepoint. No dose-selection result or analysis records are listed. Safety entries include 0 serious adverse events, 1 affected by other adverse events, and 0 deaths in the treatment group. These counts are descriptive and limited; the record does not provide a comparator or detailed event information.