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 Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (NCT04674306), a non-randomized early/phase 1 study. The primary outcome is Treatment Cohort MTD of α-lactalbumin Vaccine.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04674306 |
| Phase | EARLY/Phase 1 |
| Condition | Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Residual Disease |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | George T. Budd |
| Results posted | Yes |
2. Clinical Question
Population
The registry record describes several populations: people with operable, non-metastatic triple-negative breast cancer, including people with residual disease; people with genetic risk for triple-negative breast cancer who plan prophylactic mastectomy; and people receiving adjuvant pembrolizumab after treatment for operable disease. The primary outcome applies only to Cohort 1a, the treatment cohort. The record lists an enrollment of 35, but it does not report how enrollment was distributed across cohorts or how many participants contributed data to the primary outcome.
Intervention
The study evaluates an α-lactalbumin vaccine administered with zymosan. In the treatment cohort, participants were to receive successively higher doses in a 3 + 3 trial design. The description states that treatment involved 3 vaccinations every 2 weeks. The prevention cohort was to receive doses based on the TNBC cohort, while the adjuvant pembrolizumab cohort was to receive α-lactalbumin concurrently with standard-of-care adjuvant pembrolizumab. The registry record does not report the actual dose received by each participant.
Comparator
There is no randomized comparator. The study is listed as non-randomized and unmasked, with a parallel model. Its treatment, prevention, and pembrolizumab cohorts differ in their clinical circumstances and are not like-for-like control groups. Consequently, differences between cohort descriptions or dose groups cannot be interpreted as randomized comparisons of vaccine against no vaccine or against another treatment.
Primary question
The primary outcome asks for the maximum tolerated dose of the α-lactalbumin vaccine in participants with operable triple-negative breast cancer, assessed at Day 84. The registry record lists the outcome in micrograms (mcg), but does not report a value. The study summary also describes safety and dose selection as aims. This record therefore identifies a dose-finding question, not a reported estimate of vaccine efficacy or a comparative treatment effect.
In statistical terms, the question is whether the treatment cohort's dose escalation produced a registry-reported maximum tolerated dose by the stated assessment time. The record also lists lowest immunologic dose outcomes for the treatment, preventative, and pembrolizumab cohorts. Their outcome values are not reported in the registry record. Nor does the record provide a result connecting immune response to clinical outcomes. The description of the trial's aim should therefore be distinguished from evidence of a measured result: the primary outcome is named, but its value and supporting analysis are not reported in the registry record.
3. Trial Design
This is a non-randomized, unmasked, parallel-group early phase 1 study. The registry lists an enrollment of 35 and a completed status. Its recorded primary completion date is 2025-12-15. These are registry characteristics; they do not establish how many participants were treated, completed follow-up, or contributed to a particular endpoint. Those counts are not reported in the registry record.
The trial includes clinically different cohorts. Cohort 1a is the treatment cohort for people with operable triple-negative breast cancer. Its description specifies successively higher vaccine doses with zymosan in a 3 + 3 design, and 3 vaccinations every 2 weeks. The record describes a prevention cohort for people with genetic risk who plan prophylactic mastectomy, and a cohort receiving adjuvant pembrolizumab with the vaccine. These cohorts address different settings and should not be treated as interchangeable arms of a controlled comparison.
The stated primary outcome is the treatment cohort's maximum tolerated dose at Day 84. The primary outcome applies only to Cohort 1a, rather than to all participants or cohorts. Secondary outcomes include lowest immunologic dose outcomes for the treatment, preventative, and pembrolizumab cohorts. The registry record does not report the numerical results of these outcomes.
Because allocation was not randomized and masking was absent, comparisons across dose groups or cohorts may reflect differences in dose, cohort eligibility, treatment context, or other factors. The record does not report a control group assigned to receive no vaccine or an alternative vaccine regimen. It also does not report a statistical analysis plan, eligibility details beyond the cohort descriptions, or a sample-size justification. The design is best understood as dose-finding and descriptive rather than as a randomized estimate of comparative efficacy.
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.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan |
|---|---|---|---|---|---|---|
| STARTED | 6 | 5 | 5 | 1 | 6 | 3 |
| COMPLETED | 6 | 5 | 5 | 0 | 6 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan |
|---|---|---|---|---|---|---|
| Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: This outcome measure only applies to Cohort 1a (treatment cohort).
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.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 5 | 5 | 1 | 6 | 3 | |
| Age, Customized: 30-39 years | Participants | 0 | 1 | 1 | 0 | 1 | 0 |
| Age, Customized: 40-49 years | Participants | 1 | 2 | 3 | 0 | 0 | 1 |
| Age, Customized: 50-59 years | Participants | 1 | 0 | 0 | 1 | 2 | 1 |
| Age, Customized: 60-69 years | Participants | 4 | 1 | 0 | 0 | 1 | 0 |
| Age, Customized: 70-79 years | Participants | 0 | 1 | 1 | 0 | 2 | 1 |
| Sex: Female, Male: Female | Participants | 6 | 5 | 5 | 1 | 6 | 3 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 5 | 5 | 1 | 6 | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 1 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 1 | 0 |
| Race (NIH/OMB): White | Participants | 6 | 4 | 5 | 1 | 4 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Treatment Cohort MTD of α-lactalbumin Vaccine, measured over Day 84.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | microgram (mcg) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum tolerated dose of the α-lactalbumin vaccine in participants with operable triple-negative breast cancer. The registry specifies the unit as micrograms (mcg), the assessment time as Day 84, and the relevant population as Cohort 1a. No numerical maximum tolerated dose is reported in the registry record.
In general, a maximum tolerated dose is used in early-phase dose-finding research to identify a dose that meets a protocol-defined tolerability standard. It helps characterize dose selection and safety in the setting studied; it is not, by itself, a measure of whether a treatment improves cancer outcomes. The registry describes successive dose increases and a 3 + 3 design for the treatment cohort, but the precise toxicity criteria, dose-limiting event definition, observation window for those events, and dose-escalation decisions are not reported in the registry record. Those details are important because they determine how a maximum tolerated dose is assigned.
The record also lists lowest immunologic dose as a secondary outcome in three cohorts. In general, an immunologic dose endpoint concerns the dose associated with a defined immune response, but the specific response definition and the results are not reported in the registry record. Neither the primary endpoint nor the listed secondary outcomes should be read as evidence of clinical benefit without reported outcome values and analyses that address clinical outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a dose-finding study and names the primary outcome, but it does not report the outcome value. Thus, the posted results do not establish which dose, if any, was selected as the maximum tolerated dose in Cohort 1a. The listed assessment time, Day 84, indicates when the outcome is framed, but does not provide information about the number of participants assessed or the events observed by that time.
The study is non-randomized and has no masking. Its cohorts also represent different clinical contexts: treatment of operable disease, prevention among people at genetic risk, and vaccine use alongside adjuvant pembrolizumab. These are not equivalent comparison groups. Observed differences across cohorts, if reported elsewhere, could not automatically be attributed to the vaccine, because the registry does not describe random allocation or a common control group. No comparative efficacy estimate is reported in this record.
The adverse-event listings provide descriptive counts for the groups named in the registry. Serious adverse events affected 0 participants in each listed Cohort 1a dose group except Cohort 1c, where 1 participant was affected. The record lists 0 deaths in every group. For other adverse events, each listed group has the same number affected as recorded at risk. These counts describe the registry's group-specific entries; they do not establish that all events were caused by the vaccine, and they do not replace a complete account of event types, severity, timing, or follow-up.
The registry record lists Anxiety at 20.0% among the top serious adverse-event terms. That percentage is reported as a term-level figure; the record excerpt does not give enough context to identify its calculation details or to relate it to a particular dose group. It should not be interpreted as a comparative risk estimate.
The record lists 6 outcome measures and 0 analyses. The outcome names and adverse-event entries therefore offer some information about what was tracked, but they do not supply a reported inferential analysis for the primary endpoint. There are no reported confidence intervals or statistical tests for the primary outcome in the registry record. Without an endpoint value, analysis details, and adequate context for the observed counts, precision and generalizability cannot be assessed. These limitations mean that the registry supports a description of the study's aims and design, not a conclusion about effectiveness.
9. Statistical Methods Explained
What does a 3 + 3 dose-escalation design mean?
In general, a 3 + 3 design is a dose-finding approach in which small groups are treated at a dose and decisions about escalation depend on observed tolerability under protocol-defined rules. It is different from a randomized comparison designed to estimate the difference between treatment and control. The registry says that the treatment cohort used a 3 + 3 design with successively higher doses, but does not report the specific dose-escalation rules, the definition of a dose-limiting toxicity, or the observed decisions at each dose. The design label alone is not enough to reconstruct the dose-selection process or verify the maximum tolerated dose.
What does the maximum tolerated dose measure?
In general, the maximum tolerated dose is a dose-selection endpoint based on a prespecified tolerability boundary. It is not a direct measure of tumor response, recurrence, or survival. For this study, the endpoint is stated for Cohort 1a at Day 84 and is expressed in micrograms (mcg). The registry record does not report the selected dose or the criteria used to determine it. It also does not report participant-level exposure, dose interruptions, dose reductions, or the number of participants evaluable for the endpoint.
How should the different cohorts be understood?
The record describes a treatment cohort, a prevention cohort, and a cohort receiving standard-of-care adjuvant pembrolizumab with the vaccine. The treatment cohort includes successive dose levels; the prevention cohort concerns people with genetic risk who plan prophylactic mastectomy; and the pembrolizumab cohort concerns people receiving adjuvant therapy after treatment for operable triple-negative disease. In general, cohorts with different eligibility and treatment contexts cannot be treated as if they were randomized arms from one common comparison. Their outcomes may be shaped by differences in population, concurrent care, and dose as well as by the study intervention. No adjustment method for such differences is reported in the registry record.
What would a confidence interval add?
In general, a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the statistical method used. A narrow interval indicates greater precision than a wide interval, while neither an interval nor a point estimate by itself removes bias from a non-randomized design. The registry record does not report a confidence interval for the maximum tolerated dose or a related inferential result. Since it also does not report the primary outcome value, its precision cannot be evaluated from the registry entry.
Why do event counts need context?
In general, safety counts are interpreted in relation to the number of people at risk, the period of observation, the event definition, and the completeness of follow-up. Serious events and other adverse events are distinct categories in the registry listing. A count of affected participants does not show the number of event episodes, whether events were related to the vaccine, or how long participants were followed. Those details are not reported in the registry record. The group-specific entries can be described, but they do not support a causal comparison across non-randomized cohorts.
How should planning calculations be read?
In general, a sample-size calculation is a planning exercise tied to an assumed effect, allocation, significance level, and analysis method. It is not observed power and does not describe the achieved precision of a completed trial. The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is a stated fraction of an observed effect. Those assumptions do not describe the trial's own non-randomized cohort structure. The registry record does not report a sample-size justification for the trial. Any such planning illustration should therefore be kept separate from the study's enrollment and from claims about what the trial was able to detect.
In general, an unadjusted recalculation based on summary statistics would not supersede the sponsor's own analysis if the two differed. The registry record lists 0 analyses and does not provide a sponsor analysis for the primary outcome. As a result, there is no reported primary analysis to use for assessing statistical significance, estimating uncertainty, or resolving any discrepancy.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 6 outcome measures, including the primary maximum tolerated dose outcome and secondary lowest immunologic dose outcomes for three cohorts. It does not report a statistical analysis plan that explains how outcomes were prioritized beyond the designated primary outcome, how multiple endpoints were handled, or whether any multiplicity adjustment was planned. The result values for the listed immunologic outcomes are not reported in the registry record.
Missing-data handling is also not reported in the registry record. The entry does not state how participants with incomplete Day 84 assessments, missed vaccinations, withdrawal, or unavailable immune-response measurements were handled. It does not report endpoint-specific analysis populations, the number assessed for each outcome, or reasons for missing observations. Enrollment alone cannot establish the denominator used for any endpoint.
The record does not describe whether the primary outcome analysis was based on all enrolled participants, participants who received treatment, or an evaluable subset. It also does not report whether safety summaries included all treated participants or another defined population. These definitions matter because different analysis populations can yield different summaries, particularly in a dose-finding study where the number of participants at each dose may differ.
The registry record lists 0 analyses. This does not establish that no analysis was conducted outside the registry; it means that the registry entry does not report analyses to evaluate. Without a stated analysis plan, endpoint-specific denominators, missing-data rules, and results, it is not possible to assess the impact of missingness or multiplicity on the reported evidence.
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 |
|---|---|---|---|
| Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | 0 | 6 | 0.0% |
| Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | 0 | 5 | 0.0% |
| Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | 0 | 5 | 0.0% |
| Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | 0 | 1 | 0.0% |
| Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | 0 | 6 | 0.0% |
| Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan | 0 | 3 | 0.0% |
| Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan | 0 | 4 | 0.0% |
| Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan | 1 | 5 | 20.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | 0 of 6 |
| Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | 0 of 5 |
| Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | 0 of 5 |
| Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | 0 of 1 |
| Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | 0 of 6 |
| Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | 6 of 6 |
| Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | 5 of 5 |
| Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | 5 of 5 |
| Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | 1 of 1 |
| Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | 6 of 6 |
| Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan |
|---|---|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 1 | 0 of 6 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan | Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan |
|---|---|---|---|---|---|---|---|
| Injection site reaction | General disorders | 6 of 6 | 5 of 5 | 5 of 5 | 1 of 1 | 6 of 6 | 3 of 3 |
| Flu like symptoms | General disorders | 0 of 6 | 1 of 5 | 1 of 5 | 0 of 1 | 0 of 6 | 2 of 3 |
| Nausea | General disorders | 2 of 6 | 1 of 5 | 0 of 5 | 0 of 1 | 0 of 6 | 1 of 3 |
| Fatigue | General disorders | 0 of 6 | 0 of 5 | 2 of 5 | 0 of 1 | 1 of 6 | 0 of 3 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0 of 6 | 0 of 5 | 0 of 5 | 1 of 1 | 2 of 6 | 0 of 3 |
| Headache | Nervous system disorders | 0 of 6 | 1 of 5 | 1 of 5 | 0 of 1 | 0 of 6 | 0 of 3 |
| Alanine aminotransferase (ALT) increased | Investigations | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 1 | 0 of 6 | 1 of 3 |
| Alkaline phosphatase (ALP) increased | Investigations | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 1 | 0 of 6 | 1 of 3 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 6 | 0 of 5 | 0 of 5 | 0 of 1 | 0 of 6 | 0 of 3 |
| Anemia | Blood and lymphatic system disorders | 0 of 6 | 1 of 5 | 0 of 5 | 0 of 1 | 0 of 6 | 0 of 3 |
Serious events with the highest arm-level rate: anxiety (20.0%).
The adverse-event listing separates serious adverse events from other adverse events and gives group-specific counts of participants at risk and affected. For serious adverse events, the listed Cohort 1a dose groups each report 0 affected participants. Cohort 1c, the standard-of-care pembrolizumab cohort, reports 1 affected participant among 5 at risk. The registry lists 0 deaths for every group.
For other adverse events, each group reports the same affected count as its at-risk count: 6 of 6, 5 of 5, 5 of 5, 1 of 1, 6 of 6, 3 of 3, 4 of 4, and 5 of 5, respectively, across the listed groups. The registry also identifies Anxiety at 20.0% among the top serious adverse-event terms. The record does not provide enough information in that listing to establish the term's dose-group context or calculation details.
These are descriptive registry counts, not evidence that an event was caused by the vaccine. The record does not report event timing, severity grades, relatedness assessments, recurrent-event counts, follow-up completeness, or the criteria used to classify events as serious. Because the cohorts are not randomized comparisons, their counts should not be read as comparative estimates of risk.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed early phase 1 study that evaluated an α-lactalbumin vaccine with zymosan in treatment, prevention, and adjuvant pembrolizumab settings. It identifies a primary dose-finding endpoint for Cohort 1a, at Day 84, and lists secondary immunologic dose outcomes. It also reports group-specific adverse-event counts. These details describe the study's scope and some of its recorded safety information.
The record does not report the primary maximum tolerated dose result, the secondary lowest immunologic dose results, or analyses of those endpoints. It therefore does not establish which dose was selected, how precisely it was estimated, or whether a dose produced a particular immune response. The posted information also does not provide a comparative estimate of recurrence, tumor response, or survival. No conclusion about clinical efficacy can be drawn from the endpoint names or adverse-event counts alone.
Non-randomized allocation and the absence of masking limit causal interpretation. The prevention cohort, treatment cohort, and pembrolizumab cohort differ in population and clinical setting; they are not control groups for one another. The safety counts should likewise be read as descriptive, because the registry does not report event attribution or enough follow-up detail to interpret the counts as comparative risks.
In general, early-phase dose-finding studies can inform later research by characterizing tolerability and dose selection. That general role does not mean the registry has reported a usable dose estimate in this case. The record's stated aims and design are distinct from evidence of a result. The most defensible reading is that the registry identifies what the study set out to assess, while leaving the primary outcome result and key analytical details unreported.
13. Why This Trial Matters Statistically
This study raises statistical issues that are common in early-phase clinical research. A dose-finding endpoint such as maximum tolerated dose is not the same as an efficacy endpoint, and its interpretation depends on the toxicity definition, observation period, dose-escalation rules, and number of evaluable participants. The registry names the endpoint and its assessment time but does not report the result or the detailed rules needed to assess how it was determined.
The study also illustrates why cohort structure matters. Treatment, prevention, and adjuvant pembrolizumab settings describe different populations and care contexts. Since allocation is non-randomized, contrasts across those settings do not isolate the effect of the vaccine. Clear distinctions between cohort descriptions, within-cohort dose finding, and between-group comparisons are essential to avoid overinterpreting descriptive data.
Safety summaries also require more than counts alone. At-risk denominators, event definitions, timing, severity, relatedness, and follow-up determine what a count can support. The registry reports group-specific affected counts and deaths, but does not report many of these interpretive details. The entries are informative as a record of reported counts, not a complete statistical account of safety.
Finally, a completed status does not itself provide an endpoint result. Statistical interpretation requires the outcome values, analysis populations, missing-data approach, and uncertainty measures. Their absence from the registry record limits what can be concluded from the posted information, even though the study's design and intended questions are identifiable.
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 registry record does not report the numerical result for the primary maximum tolerated dose outcome or the secondary lowest immunologic dose outcomes. It does not report an endpoint-specific denominator, dose-specific participant flow, or the number of participants evaluable at Day 84. The listed enrollment of 35 should not be assumed to be the analysis population for any outcome.
Important protocol and analysis details are not reported in the registry record, including the definition of dose-limiting toxicity, the formal dose-escalation rules, the criteria for assigning the maximum tolerated dose, the immunologic response definition, and the method used to address missing outcomes. A statistical analysis plan and sample-size justification are also not reported. The record lists 0 analyses, so there are no posted inferential results for examining precision or testing.
The non-randomized design and different cohort contexts limit comparisons. The treatment, prevention, and pembrolizumab cohorts cannot serve as direct controls for one another. The record also does not report a concurrent control arm. Unmasked assessment may introduce additional sources of bias, although the registry does not describe which outcome assessments were subjective or how assessment procedures were managed.
Safety entries provide counts but not event-level detail such as timing, severity, relatedness, or follow-up duration. The term-level Anxiety figure is listed as 20.0%, but the registry record does not give the calculation context in the entry. These limitations constrain interpretation of both safety and dose selection and prevent a broader conclusion about clinical outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer — NCT04674306.
- Registry record last updated 2026-07-17; status last verified 2026-07.
- Results first posted 2026-07-17.
- 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
NCT04674306 is listed as a completed, non-randomized, unmasked early phase 1 parallel study with enrollment of 35. The registry record describes α-lactalbumin vaccine with zymosan across treatment, prevention, and adjuvant pembrolizumab cohorts. The treatment cohort used successively higher doses in a 3 + 3 design, with 3 vaccinations every 2 weeks.
The primary outcome is the treatment cohort's maximum tolerated dose at Day 84, in micrograms (mcg). The outcome value is not reported in the registry record. Secondary outcomes include lowest immunologic dose measures in three cohorts; their results are also not reported. The adverse-event listing includes group-specific counts, reports 0 deaths in each listed group, and identifies Anxiety at 20.0% among the top serious adverse-event terms.
The record lists 6 outcome measures and 0 analyses. It does not report a statistical analysis plan, missing-data approach, sample-size justification, or inferential results. The posted information supports a description of the trial's design and recorded adverse-event counts, but not an estimate of efficacy or a comparative treatment effect.