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 A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies (NCT04927884), a na phase 1, phase 2 study. The primary outcome is Number of Participants With Treatment Emergent Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04927884 |
| Phase | Phase 1, Phase 2 |
| Condition | Advanced Triple Negative Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ImmunityBio, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with advanced triple-negative breast cancer after at least 2 prior treatments for metastatic disease. The registry describes the study population as subjects with triple-negative breast cancer after prior therapy; the detailed characteristics of those enrolled are not reported in the registry record.
Intervention
Sacituzumab govitecan-hziy combined with cyclophosphamide, N-803, and PD-L1 t-haNK. The registry describes a single group receiving the combination; it does not report separate intervention groups.
Comparator
There is no comparator group. The study is open-label and single-group, with no randomized allocation. Its results therefore cannot provide a like-for-like comparison with another treatment or a control group.
Primary question
The registered primary endpoint counts participants with treatment-emergent adverse events during the stated follow-up period. The study summary also describes an aim to evaluate safety and efficacy, but efficacy results are not reported in the registry record.
3. Trial Design
NCT04927884 is registered as an open-label phase 1b/2 study of sacituzumab govitecan-hziy plus chemoimmunotherapy for advanced triple-negative breast cancer after prior therapy. The planned treatment group received sacituzumab with cyclophosphamide, N-803, and PD-L1 t-haNK. The study has a single-group design, with no allocation to a separate control arm and no masking.
The registry reports an enrollment of 3. Its listed start date is 2021-09-08, and its primary completion date is 2022-09-13. The status is terminated. The reason for termination, whether recruitment stopped early, and whether the enrolled participants completed the planned follow-up are not reported in the registry record.
The study summary states that the combination was to be evaluated for safety and efficacy in people with triple-negative breast cancer after at least 2 prior treatments for metastatic disease. The registered primary endpoint is a count of participants with treatment-emergent adverse events, with a timeframe of 30 days after last dose, up to 65 weeks and 5 days. The registry record does not describe a control comparison or report a statistical analysis plan. Further details about treatment schedules, eligibility criteria, dose modifications, and analysis populations are not reported in the registry record.
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: Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
Overall Study
| Stage | Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects |
|---|---|
| STARTED | 3 |
| COMPLETED | 1 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects |
|---|---|
| Progressive Disease | 2 |
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 | Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects |
|---|---|---|
| Participants analysed | 3 | |
| Age, Continuous | years | 50.7 (SD 15.95) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| 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 |
| Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments for TNBC | Participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment Emergent Adverse Events, measured over 30 days after last dose, up to 65 weeks and 5 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with treatment-emergent adverse events. It is a participant-count outcome: it describes how many people experienced an event, rather than the total number of separate events. The registered timeframe is 30 days after last dose, up to 65 weeks and 5 days.
Safety endpoints of this kind are used to describe adverse events observed during or after study treatment. They can help characterize what was reported among enrolled participants, but a count alone does not establish why an event occurred. Treatment-emergent describes when an event is observed relative to treatment; it does not by itself establish that treatment caused the event.
The registry identifies this endpoint but does not report a statistical analysis of it. The posted safety listing includes participant counts for serious and other adverse events, but the relationship between those listings and the primary endpoint is not detailed. The registry record does not report a primary endpoint estimate with an uncertainty interval or a comparative efficacy endpoint result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study enrolled 3 participants and is listed as terminated. The registry record describes a single group treated with sacituzumab govitecan-hziy plus cyclophosphamide, N-803, and PD-L1 t-haNK. Because there is no comparator group, the posted information is descriptive: it can characterize events reported among those enrolled, but it cannot establish how outcomes compare with another treatment or with no study treatment.
The registry identifies treatment-emergent adverse events as the primary endpoint and gives its observation window as 30 days after last dose, up to 65 weeks and 5 days. However, it does not report a statistical analysis for that endpoint. The safety listing reports 3 participants at risk and 3 affected for serious adverse events, and 3 at risk and 3 affected for other adverse events. It also lists 1 death. These are observations in a very small enrolled group; they are not comparative estimates, and the record does not report whether events or the death were attributed to study treatment.
The listing identifies Subdural haematoma, Central nervous system lesion, and Acute respiratory failure among the top serious adverse event terms, each with a reported 33.3%. These percentages should be read as registry-reported term frequencies, not as evidence about cause or about risk in a broader population. The record does not provide enough detail to determine whether participants experienced more than one term, the timing of each event, or the event-level definitions used in the listing.
No efficacy result is reported in the registry record. The study summary describes an intent to evaluate efficacy, but the posted information does not provide a response measure, an estimate of treatment effect, or an analysis comparing outcomes. A reader therefore cannot infer efficacy from the safety listing or from the fact that the study was conducted.
Statistical precision is also limited by the small enrollment and the absence of a reported endpoint analysis. Without an estimate and its uncertainty, the registry does not quantify how precisely an event frequency or treatment effect was measured. The terminated status adds context but does not explain why the study stopped or what conclusions the sponsor drew. Those details are not reported in the registry record.
9. Statistical Methods Explained
The posted record identifies a participant-count safety outcome, but it does not report an inferential analysis for that endpoint. The following concepts explain how such outcomes are usually interpreted in general; they should not be mistaken for methods documented for this study.
What does a participant count represent?
A participant-count endpoint counts people who experienced at least one qualifying event during the defined observation window. It is distinct from an event count, because one person may experience more than one event. A count can be informative as a descriptive safety summary, but its meaning depends on clear event definitions, follow-up, and the population included in the analysis. The registry names the endpoint and specifies its timeframe, but further event definitions and analysis-population details are not reported in the registry record.
Counts are often accompanied by a proportion, which relates the number of participants with an event to the number assessed. An uncertainty interval can then express the range of values compatible with the observed data under a statistical model. In general, intervals are important because a single estimate does not show how uncertain it is. No such primary-endpoint estimate or interval is reported in the registry record, so the precision of the primary outcome cannot be assessed from a reported analysis.
Why does the design matter?
In a single-group study, outcomes describe participants who received the study regimen. Without a comparator, observed events cannot be contrasted with events under a separate treatment or control condition. In general, a randomized comparison can help distinguish treatment-group differences from background variation and differences in participant characteristics. That type of comparison is not available in this study design. The registry explicitly lists no allocation and a single-group model.
Open-label means that masking is absent. In general, knowledge of treatment assignment can influence how symptoms are reported, assessed, or recorded, though the extent of any influence cannot be determined from the design label alone. The record does not describe specific assessment procedures that would clarify this issue.
What do the planning assumptions describe?
The registry’s sample-size illustrations are described as planning illustrations computed from an observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These assumptions do not describe the actual single-group design, which enrolled 3 participants. They are not evidence that the study was designed or powered to meet those assumptions, and they are not observed power.
In general, a planning calculation asks how much information might be needed to detect a specified effect under stated assumptions. Changing the assumed effect, variability, allocation, or statistical method can change the planning result. A normal approximation uses a mathematical approximation to a sampling distribution; whether it is suitable depends on the outcome and the amount of information available. For a participant-count or binary outcome, sparse data can make approximations less dependable. The record does not report the study’s own sample-size justification or a protocol-based target enrollment, so the planning illustrations should not be treated as the study’s design rationale.
What can be said about statistical testing?
A significance level is a threshold used in a planned statistical test to regulate how often that test would flag a result under a specified null model. It does not measure the probability that a treatment works, and it does not describe the size or importance of an effect. Although the planning assumptions state a two-sided significance level of 0.05, the registry does not report a statistical test for the primary endpoint or an efficacy comparison. The stated planning assumption therefore should not be interpreted as a test result for this trial.
Confidence intervals and hypothesis tests address different aspects of evidence. A test evaluates data against a specified null hypothesis, while an interval displays estimates and their statistical uncertainty. In general, both depend on the analysis method and assumptions. Neither can be reconstructed responsibly without the relevant outcome values and a documented approach. The registry does not report a primary outcome analysis, an effect estimate, a confidence interval, or an efficacy test.
Why is the reported sample especially important?
With only 3 participants enrolled, individual observations account for a substantial part of the available evidence. General statistical methods can describe counts, but they cannot turn a small, uncontrolled group into a reliable treatment comparison. Sparse event data also limit the ability to characterize uncommon events and the range of possible event frequencies. This is a general limitation of small samples; it does not establish what would have happened in a larger study.
The registry’s safety listing gives counts for serious and other adverse events, but no model, adjustment, or inferential procedure is reported. No recalculated analysis is presented in the record. The most defensible statistical reading is therefore descriptive and bounded to the enrolled group and posted information.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several outcomes, comparisons, subgroups, or statistical tests are examined. In general, repeated testing can increase the chance of finding at least one apparently notable result by chance, so a study’s analysis plan may specify how multiple tests will be handled. The registry record does not report a multiplicity strategy, planned hierarchy of outcomes, or details of any interim analyses. No efficacy analyses are reported, so there is no posted set of comparative tests to interpret for multiplicity.
The record identifies one primary outcome measure and reports no statistical analyses for it. This does not establish that no analyses were performed outside the registry; it means those analyses are not reported in the registry record. The timing of any analyses and whether the primary endpoint definition changed are also not reported.
Missing-data handling is not described. The registry does not state whether all enrolled participants contributed complete follow-up, how incomplete observation was treated, or whether any participants were excluded from an endpoint analysis. It also does not define an intention-to-treat, per-protocol, safety, or other analysis population. These details matter because the denominator and follow-up available for each participant affect interpretation of a count and its uncertainty.
The record’s enrollment of 3 and its terminated status do not by themselves establish why information is missing or whether termination affected the analysis. The reason for termination and any consequences for outcome ascertainment are not reported in the registry record. As a result, the available information supports a limited descriptive reading, not conclusions about the completeness or prespecification of analyses.
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 |
|---|---|---|---|
| Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects | 3 | 3 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects | 1 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects |
|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | 1 of 3 |
| Central nervous system lesion | Nervous system disorders | 1 of 3 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects |
|---|---|---|
| Nausea | Gastrointestinal disorders | 3 of 3 |
| Decreased appetite | Metabolism and nutrition disorders | 3 of 3 |
| Diarrhoea | Gastrointestinal disorders | 2 of 3 |
| Vomiting | Gastrointestinal disorders | 2 of 3 |
| Chills | General disorders | 2 of 3 |
| Fatigue | General disorders | 2 of 3 |
| Injection site pain | General disorders | 2 of 3 |
| Injection site pruritus | General disorders | 2 of 3 |
| Pain | General disorders | 2 of 3 |
| Pyrexia | General disorders | 2 of 3 |
Serious events with the highest arm-level rate: subdural haematoma (33.3%), central nervous system lesion (33.3%), acute respiratory failure (33.3%).
The registry safety listing reports 3 participants at risk and 3 affected for serious adverse events. It separately reports 3 participants at risk and 3 affected for other adverse events. The listing also reports 1 death. These figures describe the participants in this group; they are not a comparison with an untreated or alternative-treatment group.
The top serious adverse event terms are Subdural haematoma, Central nervous system lesion, and Acute respiratory failure, each reported as 33.3%. The registry record does not explain whether these terms occurred in different participants, whether a participant could contribute more than one term, or how the percentages were calculated. The terms should therefore be read as reported event categories, not added together or interpreted as a count of unique people.
Seriousness is a classification of an adverse event and does not establish that the study treatment caused it. Similarly, the term treatment-emergent refers to the event’s timing in relation to treatment, not necessarily its cause. The registry does not report attribution for the serious events or the death, nor does it provide event narratives or timing. The small enrolled group also limits what these figures can say about the frequency of events beyond the participants observed.
12. What the Result Does, and Does Not, Mean
The posted results describe safety observations in a single group of 3 participants enrolled in a study of sacituzumab govitecan-hziy with cyclophosphamide, N-803, and PD-L1 t-haNK. The registry reports counts for serious and other adverse events, lists three top serious event terms with their reported percentages, and records 1 death. Those observations are relevant to understanding what the registry lists for this group and should be interpreted with the limited enrollment and lack of a comparator in mind.
The results do not show whether the regimen changed the frequency of adverse events compared with another treatment or with no study treatment. No statistical comparison is reported. They also do not establish whether an individual event or the reported death was caused by treatment. Causal attribution and comparative safety cannot be inferred from event counts in an uncontrolled group.
The study summary describes an aim to evaluate efficacy as well as safety, but efficacy results are not reported in the registry record. There is no posted response result or comparative treatment-effect estimate to interpret. The safety figures should not be used as a substitute for an efficacy outcome.
The terminated status is an important part of the study record, but the reason for termination is not reported. The record also does not explain whether the planned follow-up was completed for every participant or how missing information was handled. These gaps limit conclusions about completeness and about the reasons the study ended. Overall, the registry supports a narrow description of the recorded study design and safety listing, not a broad claim about the regimen’s effects or the outcomes of a larger patient population.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates how design and reporting determine what can be learned from clinical data. The study was open-label and single-group, enrolled 3 participants, and is listed as terminated. Those details mean that the posted safety observations have no concurrent control group for comparison. The distinction between describing events and estimating a comparative treatment effect is central to interpreting clinical research.
The primary endpoint is framed as a participant count for treatment-emergent adverse events over a stated follow-up period. Counts can be useful for monitoring and describing safety, but their interpretation depends on who was observed, how events were defined, and how complete follow-up was. The registry does not report a statistical analysis of this endpoint or the details needed to assess its precision. This highlights why reporting a named outcome is not the same as reporting an analyzed result.
The record also shows why planning illustrations should be kept separate from a study’s actual design. The stated illustrations assume equal allocation between two arms, whereas the registered study has one group and no allocation to a comparator. Such calculations can be educational as conditional planning exercises, but they do not describe what the trial did, establish its justification, or supply evidence of observed power.
Finally, registry status and posted results need careful interpretation. Termination is reported, but the reason is not. A study’s status alone does not establish why it ended, whether all outcomes were collected, or what the sponsor concluded. Clear reporting of analysis populations, missing-data handling, endpoint results, uncertainty, and reasons for study completion would help readers assess the evidence. Those details are not reported in the registry record.
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 main trial-specific limitation is the enrollment of 3 participants in a single-group, open-label study. This does not support a like-for-like comparison, and observations from such a small group cannot characterize event frequencies precisely for a broader population. Individual events may strongly influence the description of the group, while uncommon events and variation across participants remain difficult to assess.
The registry identifies a primary safety endpoint but reports no statistical analysis of it. Although it lists serious and other adverse event counts, the record does not clarify how those listings relate to the registered primary endpoint or whether every enrolled participant contributed complete endpoint follow-up. The endpoint’s event definitions, assessment procedures, and analysis population are not reported in the registry record.
The study is marked terminated, but the reason is not reported. The registry also does not report whether termination affected recruitment, planned follow-up, or outcome collection. Without those details, the completeness of the posted information and the context for ending the study cannot be assessed.
The registry summary describes an efficacy aim, but no efficacy results are reported. A comparator, statistical analysis plan, multiplicity approach, missing-data method, and study-specific sample-size justification are also not reported in the registry record. These omissions preclude an assessment of comparative efficacy, the prespecification of analyses, and the intended precision. The planning assumptions described in the record are not a substitute for a protocol-based justification for this single-group study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies — NCT04927884.
- Registry record last updated 2024-06-12; status last verified 2024-06.
- Results first posted 2024-06-12.
- 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
NCT04927884 is an open-label phase 1b/2, single-group study sponsored by ImmunityBio, Inc. It evaluated sacituzumab govitecan-hziy with cyclophosphamide, N-803, and PD-L1 t-haNK for advanced triple-negative breast cancer after prior therapy. The registry reports an enrollment of 3, a start date of 2021-09-08, a primary completion date of 2022-09-13, and a terminated status.
The primary endpoint counts participants with treatment-emergent adverse events during 30 days after last dose, up to 65 weeks and 5 days. The safety listing reports 3 participants at risk and affected for serious adverse events, 3 at risk and affected for other adverse events, and 1 death. No statistical analysis of the primary endpoint or efficacy result is reported. The reason for termination, analysis populations, missing-data handling, and study-specific statistical plan are not reported in the registry record.