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 Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer (NCT00331552), a na phase 1, phase 2 study. The primary outcome is Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00331552 |
| Phase | Phase 1, Phase 2 |
| Condition | HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes patients with metastatic breast cancer, including HER2-positive disease, and lists stage IV, recurrent, and male breast cancer among the conditions. The study’s official title specifies HER-2/Neu-positive disease. The registry record reports enrollment of 30.
Intervention
The study combined oral cyclophosphamide with pegylated liposomal doxorubicin hydrochloride, also called Doxil in the primary outcome title. Some patients with HER2/neu 3+ disease may also have received intravenous trastuzumab. The record describes daily cyclophosphamide and an intravenous dose of liposomal doxorubicin on day 1, with treatment repeating every 4–6 weeks while there was no disease progression or unacceptable toxicity.
Comparator
There was no randomized comparator group. The registry identifies a single-group model and lists two dose-level groups: cyclophosphamide with Doxil 30 mg/m^2 and trastuzumab, and cyclophosphamide with Doxil 35 mg/m^2 and trastuzumab. These are not like-for-like control arms, so their results should not be read as a randomized treatment comparison.
Primary question
The phase I primary question was about the maximum tolerated dose and optimal tolerated dose of pegylated liposomal doxorubicin hydrochloride when combined with cyclophosphamide. The registry defines the dose-limiting criterion by treatment-related toxicity of grade 3 or higher, or a dose adjustment after the first course. The primary endpoint is not a direct test of comparative benefit.
The study also listed phase II outcomes including time to progression, progression-free survival, overall survival, and clinical benefit in subgroups defined by prior treatment for advanced disease. However, estimates for these outcomes are not reported in the registry record. The central question that can be addressed from the posted information is therefore how the trial framed dose tolerance and what its safety entries record, rather than whether the combination outperformed another treatment.
3. Trial Design
This was a completed phase I–II study registered as NCT00331552 and sponsored by the University of Washington. The registry reports enrollment of 30 and identifies the study model as single group. Allocation is listed as not applicable, and masking is listed as none. The record therefore does not describe a randomized, blinded comparison against a control treatment.
The intervention combined pegylated liposomal doxorubicin hydrochloride with cyclophosphamide. Trastuzumab was also part of the regimen for some patients with HER2/neu 3+ disease, as stated in the arm description. Cyclophosphamide was taken orally once daily on days 1–28, while pegylated liposomal doxorubicin was given intravenously over 90 minutes on day 1. The treatment cycle repeated every 4–6 weeks in the absence of disease progression or unacceptable toxicity. The registry’s listed safety groups are labelled with Doxil doses of 30 mg/m^2 and 35 mg/m^2, alongside cyclophosphamide and trastuzumab.
The study’s phase I component addressed dose tolerance. Its primary outcome was the maximum tolerated dose and optimal tolerated dose of pegylated liposomal doxorubicin hydrochloride with cyclophosphamide, assessed over up to 24 weeks. Phase II outcomes listed in the registry included toxicity, time to progression, progression-free survival, overall survival, and clinical benefit in subgroups based on prior regimens for advanced disease.
The registry reports a start date of 2006-02, a primary completion date of 2011-02, and a completed status. These entries describe the study’s registry timeline, but they do not provide a detailed account of recruitment, follow-up, or protocol conduct. The sample-size justification, planned interim analyses, and fuller statistical plan are not reported in the registry record. The dose-level groups are not a randomized comparison and should not be interpreted as though they were control and experimental arms in a comparative trial.
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.
Period 1: Doxil 30 mg/m^2 (Phase I)
| Stage | Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab |
|---|---|---|
| STARTED | 3 | 0 |
| COMPLETED | 3 | 0 |
| NOT COMPLETED | 0 | 0 |
Period 2: Doxil 35 mg/m^2 (Phase I)
| Stage | Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab |
|---|---|---|
| STARTED | 0 | 3 |
| COMPLETED | 0 | 3 |
| NOT COMPLETED | 0 | 0 |
Period 3: Phase II
| Stage | Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab |
|---|---|---|
| STARTED | 24 | 0 |
| COMPLETED | 22 | 0 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab |
|---|---|---|
| Neurological Symptoms | 1 | 0 |
| Severe Nausea | 1 | 0 |
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 | Phase I: Cyclophosphamide, Doxil, Trastuzumab | Phase II: Cyclophosphamide, Doxil, Trastuzumab | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 24 | 30 | |
| Age, Continuous | years | 49.5 (37 to 72) | 57 (40 to 77) | 56.5 (37 to 77) |
| Sex: Female, Male: Female | Participants | 6 | 23 | 29 |
| Sex: Female, Male: Male | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 24 | 30 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 4 | 21 | 25 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I), measured over Up to 24 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/m^2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns the maximum tolerated dose and optimal tolerated dose of pegylated liposomal doxorubicin hydrochloride when given with cyclophosphamide. The registry states that the endpoint is assessed over up to 24 weeks. It defines the relevant dose level using a treatment-related toxicity of grade 3 or higher, or a dose adjustment following the first course of treatment.
In general, dose-finding endpoints are used to guide selection of a dose for further study by balancing the amount of treatment administered against treatment-limiting toxicity. This is different from an endpoint designed to compare tumor response or survival between treatment groups. Here, the endpoint title identifies dose selection as the primary phase I aim; the registry does not report a numerical dose-selection result or specify how the optimal tolerated dose was distinguished from the maximum tolerated dose.
The registry lists time to progression, progression-free survival, overall survival, and clinical benefit rate in prior-treatment subgroups as phase II outcomes. These outcomes could describe disease course or clinical benefit, but their results are not reported in the registry record. Accordingly, the primary endpoint information establishes what the study intended to assess, not the dose ultimately selected or the magnitude of any clinical outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supports a limited interpretation. It describes a phase I–II, single-group study of a regimen involving cyclophosphamide and pegylated liposomal doxorubicin, with trastuzumab for some patients with HER2/neu 3+ disease. The phase I primary endpoint was dose tolerance, defined in terms of serious treatment-related toxicity or dose adjustment after the first course. The record does not include a reported result for that endpoint, so the dose identified as maximum tolerated or optimal tolerated cannot be established from this information.
The safety section lists two dose-labelled groups. In the group labelled Doxil 30 mg/m^2, 27 participants were at risk for serious adverse events and 0 were reported as affected; 27 were at risk for other adverse events and 27 were reported as affected. In the group labelled Doxil 35 mg/m^2, 3 participants were at risk for serious adverse events and 0 were reported as affected; 3 were at risk for other adverse events and 3 were reported as affected. No serious adverse event terms are listed. Death counts are not reported in the registry record.
Those entries are descriptive safety counts, not evidence from a randomized comparison. The registry explicitly indicates that the study was not a randomized comparison and that the arms are not like-for-like control groups. The two groups also have different numbers of participants at risk. A direct contrast between the dose-labelled groups would therefore not establish that dose alone explains any difference in observed outcomes.
The registry lists several phase II outcomes, including time to progression, progression-free survival, overall survival, and clinical benefit in subgroups defined by prior treatment. However, outcome estimates and analysis results for these measures are not reported in the registry record. The number of outcome measures is listed as 8, while the number of analyses is listed as 0. That means the registry information cannot support interpretation of a treatment effect, its precision, or the extent to which multiple analyses affected conclusions.
In general, results from a small single-group study can describe what was recorded among enrolled participants, but without a suitable comparator they cannot isolate the effect of the regimen from other explanations. In this record, even the dose-tolerance result is absent, so interpretation should remain at the level of the design and the posted safety counts. The listed sample-size assumptions are planning illustrations based on an observed effect, not the trial’s original design or observed power; no trial-specific sample-size justification is reported in the registry record.
9. Statistical Methods Explained
Several design and analysis concepts help clarify what can and cannot be inferred from this record. The registry identifies the study as phase I–II and single group, with allocation not applicable and no masking. In general, a phase I dose-finding component asks how treatment can be administered while monitoring for unacceptable toxicity. A phase II component may examine outcomes such as disease progression or survival. The registry lists both kinds of objectives, but it does not report numerical phase II results or a dose-selection result.
What does the primary endpoint capture?
The primary endpoint is the maximum tolerated dose and optimal tolerated dose of pegylated liposomal doxorubicin hydrochloride in combination with cyclophosphamide. The registry’s operational criterion refers to a dose level at which 2 or more patients develop treatment-related toxicity of grade 3 or higher, or require a dose adjustment after the first course. The stated timeframe is up to 24 weeks. This is a toxicity- and dosing-focused endpoint, rather than a direct measure of comparative tumor response or survival.
In general, a dose-finding rule translates observed toxicity and dose adjustments into a decision about dose levels. A transparent interpretation usually depends on how the dose levels were assigned, how toxicity was assessed, and what decision rule was applied. The registry record does not report the full dose-escalation method, the complete statistical plan, or the resulting dose decision. The endpoint definition alone does not reveal whether a given dose was ultimately selected.
Why is the study structure important?
A randomized comparison aims to make groups comparable through allocation, so differences between groups can be interpreted in the context of that design. This study is recorded as single group, with allocation listed as not applicable. The safety entries show two dose-labelled groups, but the registry cautions that these are not a like-for-like control comparison. They may be described as recorded groups, but they do not establish a randomized contrast between doses or treatments.
In general, lack of randomization can leave group differences open to explanations other than the assigned dose, including differences in who entered each group or how treatment was delivered. The registry does not provide enough information to assess those possibilities. The group sizes shown in the safety record are uneven, which further limits what can be learned from a simple side-by-side description; no adjusted comparison is reported.
How should uncertainty be understood?
A confidence interval, in general, describes a range of values compatible with the data and a specified statistical method. It communicates precision as well as the direction or magnitude of an estimate. The registry information does not include confidence intervals for the safety counts or for the listed phase II outcomes. As a result, the precision of any underlying event rate or clinical outcome estimate cannot be assessed from this record alone.
In general, small samples tend to yield less precise estimates, especially for uncommon outcomes. A count of no serious adverse events in a group is a description of what was recorded in that group; it does not establish that the true risk is zero. The registry does not provide a confidence interval or additional follow-up detail that would quantify uncertainty around these counts.
What do the planning illustrations mean?
The sample-size section uses planning assumptions based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such calculations are illustrations of sample sizes under stated assumptions, not the trial’s own design rationale. They are not observed power. In general, a planning calculation depends on the effect size chosen for detection and the analysis assumptions; changing those assumptions changes the planning result. The registry does not report its original sample-size justification, and the dose-labelled groups in this study are not a randomized two-arm comparison.
The sample-size assumptions also distinguish between time-to-event outcomes, for which a total number of events is used, and other outcomes, for which participants per arm are used. That distinction is general to the calculation framework described on the page. It does not make the study’s groups comparable or supply missing trial results. No new estimate of treatment effect or precision can be derived from the registry entries alone.
What is missing from the statistical record?
The registry lists 8 outcome measures and 0 analyses. It names secondary outcomes, but does not report their estimates, confidence intervals, or analysis methods. The analysis population, handling of missing observations, and approach to multiplicity are not reported in the registry record. In general, multiplicity matters when several endpoints or subgroup comparisons are examined, because the chance of a false-positive finding can increase across repeated tests. Without the analysis plan and results, it is not possible to determine how that issue was handled.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including the primary dose-tolerance outcome and secondary outcomes for toxicity, time to progression, progression-free survival, overall survival, and clinical benefit in subgroups defined by prior treatment for advanced disease. It lists 0 analyses. The outcome list therefore shows what was registered, but the record does not provide the corresponding statistical results or describe which analyses were conducted.
Multiplicity is relevant in general when a study examines several outcomes, time points, or subgroups. Repeated statistical tests can increase the chance of at least one apparently positive result arising by chance. The registry does not report whether multiplicity adjustments were planned or used, nor does it describe a hierarchy for interpreting outcomes. It is not possible to infer the study’s approach from the list of endpoints alone.
Missing-data procedures and analysis populations are also not reported in the registry record. In general, interpretation can depend on who was included in each analysis and how unavailable measurements or incomplete follow-up were handled. The record does not specify an intention-to-treat population, a safety population, or another analysis set, and it does not state how missing outcome observations were treated.
The sample-size assumptions shown with the page are planning illustrations rather than the trial’s own design justification. The registry’s sample-size justification, interim analysis plan, and fuller statistical plan are not reported. Consequently, the posted information does not establish how the investigators planned to address multiplicity, missing data, or the analysis populations for the phase II outcomes.
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 |
|---|---|---|---|
| Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | 0 | 27 | 0.0% |
| Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab | 0 | 3 | 0.0% |
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 |
|---|---|
| Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | 27 of 27 |
| Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab | 3 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab | Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab |
|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 19 of 27 | 3 of 3 |
| Neutropenia | Infections and infestations | 18 of 27 | 3 of 3 |
| Nausea | Gastrointestinal disorders | 14 of 27 | 1 of 3 |
| Fatigue | General disorders | 12 of 27 | 0 of 3 |
| Anemia | Blood and lymphatic system disorders | 8 of 27 | 0 of 3 |
| Hand Foot Syndrome | Skin and subcutaneous tissue disorders | 7 of 27 | 1 of 3 |
| Rash | Skin and subcutaneous tissue disorders | 7 of 27 | 0 of 3 |
| AST High | Metabolism and nutrition disorders | 5 of 27 | 1 of 3 |
| Mucositis | Gastrointestinal disorders | 4 of 27 | 1 of 3 |
| Hyponatremia | Metabolism and nutrition disorders | 4 of 27 | 1 of 3 |
The registry lists serious and other adverse-event counts for two dose-labelled groups. For cyclophosphamide with Doxil 30 mg/m^2 and trastuzumab, 27 participants were at risk for serious adverse events, with 0 affected; 27 were at risk for other adverse events, with 27 affected. For cyclophosphamide with Doxil 35 mg/m^2 and trastuzumab, 3 participants were at risk for serious adverse events, with 0 affected; 3 were at risk for other adverse events, with 3 affected. The record lists no serious adverse event terms. Deaths are not reported in the registry record.
These are counts of participants reported as affected, not counts of individual episodes. The registry does not give details about event type, grade, timing, duration, or attribution for the other adverse events. The absence of a listed serious event is not proof that serious risk is absent; it describes the posted observations in these groups.
The groups are not randomized, and the registry cautions that they are not a like-for-like control comparison. Their safety counts should therefore be read descriptively, not as evidence that one dose caused more or fewer events than the other. No statistical comparison or uncertainty interval for these counts is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted record describes the study’s question and design more fully than it reports results. It shows a completed phase I–II, single-group study of cyclophosphamide and pegylated liposomal doxorubicin hydrochloride, with trastuzumab for some patients with HER2/neu 3+ disease. The primary endpoint concerned dose tolerance, with a toxicity or dose-adjustment criterion over up to 24 weeks. The record does not report the dose identified as maximum tolerated or optimal tolerated.
The safety entries show 0 participants affected by serious adverse events in each of the two dose-labelled groups, alongside participants reported as affected by other adverse events in each group. These are descriptive counts. The record does not provide detailed event descriptions or death counts, and it does not report uncertainty estimates for the safety figures. The counts should not be treated as a complete account of all possible safety outcomes.
The study also registered outcomes related to progression, survival, toxicity, and clinical benefit in subgroups. Estimates for those outcomes are not reported in the registry record. Thus, this record cannot establish the magnitude or precision of any effect on disease course, survival, or clinical benefit. Nor does it support a comparison of the two dose-labelled groups as if they were randomized arms.
In general, a single-group study can document outcomes observed during treatment, but without a suitable comparator it cannot separate the contribution of the regimen from other factors. The registry’s completion status does not fill the gap left by unreported estimates or analysis methods. The appropriate reading is therefore narrow: the record identifies the study’s aims, regimen, design, and posted safety counts, while leaving the primary dose result and phase II outcome findings unavailable.
This does not mean the study had no findings; it means those findings are not reported in the registry record reviewed. The record alone also cannot establish how precisely outcomes were measured, how missing information was handled, or whether multiple analyses influenced interpretation. Those uncertainties limit the conclusions that can be drawn from the posted information.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it places a dose-finding question beside a set of later clinical outcomes. The primary endpoint is about dose tolerance, using treatment-related toxicity of grade 3 or higher or a dose adjustment following the first course. The registry separately lists progression, survival, toxicity, and subgroup clinical benefit outcomes. These objectives are related, but they answer different questions: a dose-selection endpoint is not interchangeable with a comparative efficacy endpoint.
The record also illustrates why design labels matter. A single-group study with no randomized allocation can describe the experience recorded among participants, but does not create a randomized estimate of treatment effect. The two dose-labelled groups in the safety section are explicitly not like-for-like control groups. A numerical contrast between them would not, by itself, isolate the effect of dose.
The listed safety counts also show the difference between a descriptive observation and a precise risk estimate. In general, event counts should be interpreted alongside group size, event definitions, follow-up, and uncertainty. The registry provides counts at risk and affected, but not confidence intervals or detailed descriptions of the other adverse events. The absence of recorded serious events in these groups is not the same as proof of no serious risk.
Finally, registration of an outcome is not the same as reporting an analyzed result. Although the registry lists 8 outcome measures, it lists 0 analyses and does not report the dose decision or phase II estimates. This distinction is important for readers assessing whether the available evidence answers the registered questions. The record is useful for understanding the intended design and the limits of the posted results, but it does not support a quantitative conclusion about clinical benefit.
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 most direct limitation is that the registry record does not report a result for the primary dose-tolerance endpoint. It gives the endpoint definition and timeframe, but not the dose selected or the observed toxicity findings used to reach a dose decision. Without that information, the main phase I question cannot be answered from this record.
The study is recorded as single group, with allocation not applicable and no masking. The safety entries are divided by Doxil dose, but the registry explicitly warns that the groups are not a like-for-like control comparison. Group sizes differ, and the record does not give enough information to determine how participants entered each dose group or whether other features differed between them. A causal comparison between dose groups is therefore not supported.
The intervention description states that some patients with HER2/neu 3+ disease may also receive trastuzumab. The registry record does not provide enough detail to determine how use of trastuzumab varied across participants or how that variation was incorporated into analyses. This further limits interpretation of the regimen as a single uniform exposure.
Although phase II outcomes are listed, their estimates and analysis results are not reported in the registry record. The record also does not describe confidence intervals, analysis populations, missing-data methods, multiplicity handling, interim analyses, or the full statistical plan. Death counts are not reported, and the safety entries do not give detailed terms for the other adverse events. These gaps limit assessment of both clinical outcomes and safety precision.
Finally, the sample-size rationale is not reported in the registry record. The planning illustrations on the page should not be mistaken for the trial’s original design or for observed power. Together, these limitations mean that the posted information is best used to describe the registered aims, design, and safety counts, not to make a comparative claim about outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer — NCT00331552.
- Registry record last updated 2017-07-26; status last verified 2017-06.
- Results first posted 2017-07-26.
- 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
NCT00331552 is a completed phase I–II, single-group study sponsored by the University of Washington, with enrollment reported as 30. It examined pegylated liposomal doxorubicin hydrochloride with cyclophosphamide, with trastuzumab for some patients with HER2/neu 3+ disease. The primary endpoint addressed maximum tolerated and optimal tolerated dose over up to 24 weeks, using a toxicity or dose-adjustment criterion.
The registry lists phase II outcomes for time to progression, progression-free survival, overall survival, and subgroup clinical benefit. It reports safety counts for two dose-labelled groups, but the groups are not randomized controls. The dose-selection result, phase II outcome estimates, analysis methods, and deaths are not reported in the registry record. The record supports description of the design and posted safety entries, but not a comparative treatment-effect conclusion.