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 Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194 (NCT00820170), a na phase 1, phase 2 study. The primary outcome is Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00820170 |
| Phase | Phase 1, Phase 2 |
| Condition | Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 55 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with metastatic breast carcinoma. The registry lists an enrollment of 55. It does not report detailed eligibility criteria or a full description of the population assessed for the primary endpoint. The primary-outcome population description states that participants treated in Phase I at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg were included in the Phase II group of 40, and that the results and data analysis reflect this.
Intervention
The regimen combined dasatinib with weekly paclitaxel. In Phase I, dasatinib was given at different dose levels with Paclitaxel 80 mg/m2, as part of a dose-escalation study. The Phase II group is described at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg. Treatment schedules beyond the stated weekly paclitaxel and dose information are not reported in the registry record.
Comparator
There was no separate comparator arm. The registry identifies the study as single-group, with allocation listed as not applicable and masking listed as none. The dose cohorts in Phase I are not a randomized control comparison. Differences in their event counts should not be read as estimates of the regimen’s effect relative to another treatment.
Primary question
The primary question was whether the combination at the maximum tolerated dose established during Phase I produced an objective response, defined as complete response or partial response. The endpoint was recorded as a count of participants, with assessment through study completion, up to 2 years. The actual response count and corresponding estimate of response are not reported in the registry record, so the primary question cannot be answered from the posted results.
3. Trial Design
The registry describes a Phase I–II study sponsored by Memorial Sloan Kettering Cancer Center. Its status is completed; the recorded start was 2009-01 and primary completion was 2018-08. The study enrolled patients with metastatic breast carcinoma and tested dasatinib in combination with weekly paclitaxel.
The Phase I portion used a dose-escalation approach described as a standard three-patient-per-cohort schedule. The stated purpose was to identify the maximum tolerated dose of dasatinib when combined with paclitaxel. The arm description says between 6 and 54 patients would likely be necessary for this determination. This is a description of the planned dose-finding process, not a reported analysis of its operating characteristics or a statement about the number actually treated in each Phase I cohort.
The Phase II portion is described as having a Simon two-stage design. The registry record does not report the full stage rules, decision thresholds, or target response rates; its Phase II arm description is incomplete. The Phase II group is listed at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg. The primary-outcome population description says that the 3 participants treated in Phase I at this dose combination were included among the 40 Phase II participants, and that the results reflect this. These overlapping descriptions should not be interpreted as separate, non-overlapping groups.
The registered study model is single-group, with no masking. Consequently, the multiple dose cohorts do not provide a randomized comparison against a control treatment. The registry enrollment is 55, but a complete account of enrollment by phase and cohort is not reported in the registry record. The overall design combines dose-finding and a later assessment of objective response, alongside secondary safety, survival, progression, and biomarker outcomes.
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.
Overall Study
| Stage | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | Participants Who Did Not Receive Treatment |
|---|---|---|---|---|---|
| STARTED | 3 | 5 | 3 | 40 | 4 |
| COMPLETED | 3 | 5 | 3 | 40 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 4 |
Reasons for not completing this period:
| Reason | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | Participants Who Did Not Receive Treatment |
|---|---|---|---|---|---|
| Adverse Event | 0 | 0 | 0 | 0 | 2 |
| Progressive Disease | 0 | 0 | 0 | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: 15 participants were enrolled for the Phase I portion of the study. These 15 participants determined the MTD for the study.
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.
Population: The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
| Characteristic | Unit | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | No Arm Selected | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 5 | 3 | 40 | 4 | 55 | |
| Age, Continuous | years | 53 (39 to 67) | 56 (41 to 74) | 59 (54 to 62) | 50.7 (30 to 79) | 52.5 (47 to 58) | 51.89 (30 to 79) |
| Sex: Female, Male: Female | Participants | 3 | 5 | 3 | 37 | 4 | 52 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 3 | 0 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 3 | 2 | 5 |
| 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 | 1 | 1 | 5 | 0 | 7 |
| Race (NIH/OMB): White | Participants | 3 | 4 | 2 | 32 | 2 | 43 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 3 | 5 | 3 | 40 | 4 | 55 |
6. Primary Endpoint
The registry lists the primary outcome as Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial., measured over Through study completion, up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was efficacy measured as objective response rate, defined in the registry title as complete response plus partial response. The outcome was recorded as a count of participants. Objective response is used in oncology studies to describe tumor shrinkage meeting response criteria, rather than simply recording whether a participant remained on treatment or survived for a specified period. The registry record does not describe the response criteria or the assessment procedures, so those details cannot be evaluated from this entry.
The primary endpoint was tied to the maximum tolerated dose established during Phase I. The stated assessment period was through study completion, up to 2 years. This links the Phase I dose-finding objective to a Phase II assessment of tumor response at the selected dose combination. In this record, the Phase II dose is listed as Paclitaxel 80 mg/m2 plus Dasatinib 120 mg.
Although the endpoint definition is present, the registry record does not report the number of complete responses, partial responses, or participants with either type of response. It also does not report an objective-response proportion, confidence interval, or statistical test. Therefore the endpoint definition explains what the study intended to measure, but the posted information does not quantify the observed response result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes that the study was completed and identifies its primary objective: count participants with complete or partial response while receiving dasatinib with weekly paclitaxel at the Phase I maximum tolerated dose. It does not report the primary response count or an estimate of objective response. There is therefore no posted primary effect estimate to interpret for magnitude or precision. The registry record also does not report a confidence interval or primary-endpoint p-value.
The design matters for interpretation. This was a single-group study, not a randomized comparison. Its dose cohorts served the Phase I dose-finding purpose and should not be treated as equivalent treatment and control groups. Differences in the reported event counts across dose levels could reflect differences in cohort size, participant characteristics, exposure, follow-up, or chance; the record does not provide information that would support a causal comparison between those cohorts.
The registry describes a Phase II group of 40 at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg, and states that the 3 participants treated at this dose during Phase I were included in that group. This is important when reading the population description: those participants are described as included, not as an additional group to be added to the Phase II group. The record does not give further details about how all participants were assigned to analysis populations.
Some safety information is reported as counts of participants with serious adverse events in the listed groups. Those counts provide a descriptive account of events recorded for the cohorts, not a comparison of harms against an untreated or alternative-treatment group. The registry also lists serious-event terms with percentages, but does not identify the denominator or provide enough context to connect those percentages to a particular cohort. The death counts are recorded separately; causes, timing, and relationship to study treatment are not reported in the registry record.
The registry lists secondary outcomes involving overall survival, progression-free survival, time to progression, adverse events, and biomarker or circulating tumor cell measures. Listing an outcome does not establish that its result is available or that an analysis was performed. The analysis count is recorded as 0, and numerical results for these secondary outcomes are not reported in the registry record. Thus, the posted information supports a description of design and selected safety counts, but not conclusions about response, survival, progression, or comparative treatment effects.
Any planning illustration based on an observed effect should be kept separate from the study’s actual design and results. The stated assumptions for that illustration are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is a hypothetical planning calculation, not observed power; moreover, the study itself is registered as single-group. The posted information does not report a primary response estimate from which to assess precision directly.
9. Statistical Methods Explained
What does a single-group design establish?
In a single-group study, outcomes are described among participants receiving the study regimen, without a randomized control group providing a concurrent counterfactual. General statistical interpretation: an observed response proportion can characterize the studied group, but by itself it cannot distinguish treatment effects from other influences on outcome. Differences between dose cohorts in a dose-escalation study are also not automatically causal comparisons. The cohorts may differ in size, treatment exposure, or participant characteristics, and the registry does not report adjustments for such differences.
For this study, the Phase I and Phase II portions addressed related but distinct aims: dose finding and response assessment. The registry says Phase I used three-patient-per-cohort dose escalation and that Phase II used a Simon two-stage design. The full Phase II stage rules and decision criteria are not reported in the registry record. Without these details, it is not possible to assess the registered design’s response thresholds or describe how a stage decision would have been made.
How should a response count be interpreted?
The primary outcome is a count of participants with complete or partial response. General statistical explanation: a count becomes easier to interpret when paired with a clearly defined analysis population and denominator, since the count alone does not convey the proportion responding. Precision is commonly described with a confidence interval. A confidence interval expresses the range of values reasonably compatible with the data under the method used; it does not remove limitations such as selection bias or the lack of a control group.
The registry record does not report the primary response count, the response proportion, or an interval estimate. It does not describe response criteria or assessment procedures. Those omissions prevent evaluation of the observed response frequency and of how precisely it was estimated. The listed endpoint timeframe is through study completion, up to 2 years, but the record does not give individual follow-up or response-assessment details.
What do the safety counts describe?
For each listed group, the record gives a number at risk and a number affected by serious adverse events. These are descriptive participant counts. They are not event rates adjusted for time under observation, and they do not show whether an event was judged related to study treatment. General statistical explanation: event counts can be difficult to compare when groups differ in size or follow-up; a rate or time-to-event analysis may address some questions, but requires appropriate data and assumptions. Such details are not reported for the serious adverse event counts in this record.
The record also lists percentages for selected serious-event terms. Because the denominator and cohort context for those percentages are not reported in the registry record, they should not be used to infer a rate for a particular dose group. The separate death counts likewise do not explain cause, timing, or treatment relationship.
What is the role of a planning calculation?
The registry’s planning assumptions describe an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. General statistical explanation: sample-size calculations estimate the number of participants or events needed to detect a specified effect under chosen assumptions. They depend on the selected effect size and analysis method. A planning illustration is not a measure of the probability that the completed study detected an effect, and it is not a substitute for an observed estimate with uncertainty.
Those assumptions do not match the registry’s single-group study description as a randomized two-arm comparison. The illustration should therefore be understood as a hypothetical planning scenario, not as a description of the trial’s own enrollment design. It is not observed power. The registry record does not report the trial’s sample-size justification or further design assumptions.
What cannot be assessed from the recorded analyses?
The registry lists nine outcome measures and records 0 analyses. It does not provide an analysis plan specifying which statistical models or estimators were used for each outcome. In general, a statistical method should be matched to the outcome: a participant response count, survival outcome, and biomarker assessment have different data structures and analytical requirements. The listed secondary outcomes include survival and progression measures as well as biomarker and circulating tumor cell assessments, but results and analytic details for them are not reported in the registry record.
Multiplicity arises when several outcomes or repeated statistical tests are considered. General statistical explanation: evaluating many outcomes can increase the chance that at least one result appears notable by chance; a prespecified testing hierarchy or adjustment can address that issue, depending on the study’s objectives. The registry does not report whether multiplicity was addressed or how secondary outcomes were prioritized. Missing-data methods, censoring rules, and sensitivity analyses are also not reported in the registry record. As a result, the available entry does not allow reconstruction of the analysis or evaluation of its robustness.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists nine outcome measures, including objective response, adverse events, overall survival, progression-free survival, time to progression, and biomarker-related outcomes. It records 0 analyses. A list of outcomes does not show which were analyzed, what models were used, or whether results were selected for reporting. A prespecified statistical analysis plan is not reported in the registry record.
Multiplicity is relevant because examining several outcomes can increase the chance of findings arising by chance. General statistical explanation: studies may address this with a testing hierarchy, a defined primary endpoint, or adjustments for multiple testing. The registry record does not report whether any such approach was used. It also does not give a hierarchy or distinguish confirmatory from exploratory analyses beyond the descriptions of the primary and secondary outcomes.
Missing-data handling is not reported in the registry record. The record does not describe how participants without an evaluable response, incomplete follow-up, or missing biomarker measurements were handled. It also does not report censoring rules for survival or progression outcomes, or sensitivity analyses for missingness.
The primary population description states that the 3 participants treated in Phase I at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg were included among the 40 Phase II participants, and that results and data analysis reflect this. Other analysis-population definitions, including the handling of participants treated at other Phase I doses, are not reported in the registry record. These gaps limit assessment of whether each outcome used the intended population and how missing or unevaluable observations affected the results.
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 |
|---|---|---|---|
| Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 | 3 | 100.0% |
| Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 2 | 5 | 40.0% |
| Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 0 | 3 | 0.0% |
| Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 11 | 40 | 27.5% |
| No Arm Selected | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 of 3 |
| Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 5 of 5 |
| Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 3 of 3 |
| Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 5 of 40 |
| No Arm Selected | 4 of 4 |
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 |
|---|---|
| Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | 3 of 3 |
| Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | 5 of 5 |
| Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | 2 of 3 |
| Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | 40 of 40 |
| No Arm Selected | 0 of 4 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | No Arm Selected |
|---|---|---|---|---|---|---|
| Hemoglobin decreased/Anemia | Blood and lymphatic system disorders | 1 of 3 | 0 of 5 | 0 of 3 | 2 of 40 | 0 of 4 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 0 of 5 | 0 of 3 | 2 of 40 | 0 of 4 |
| Arrhythmia supraventricular | Cardiac disorders | 1 of 3 | 0 of 5 | 0 of 3 | 0 of 40 | 0 of 4 |
| Fatigue | General disorders | 1 of 3 | 0 of 5 | 0 of 3 | 0 of 40 | 0 of 4 |
| Hypotension | Vascular disorders | 1 of 3 | 0 of 5 | 0 of 3 | 0 of 40 | 0 of 4 |
| Bone pain | Musculoskeletal and connective tissue disorders | 0 of 3 | 0 of 5 | 0 of 3 | 1 of 40 | 0 of 4 |
| Infection | Infections and infestations | 0 of 3 | 0 of 5 | 0 of 3 | 1 of 40 | 0 of 4 |
| Pain | General disorders | 0 of 3 | 0 of 5 | 0 of 3 | 1 of 40 | 0 of 4 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 0 of 5 | 0 of 3 | 1 of 40 | 0 of 4 |
| Pneumonia | Infections and infestations | 0 of 3 | 0 of 5 | 0 of 3 | 1 of 40 | 0 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg | Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg | Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg | Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg | No Arm Selected |
|---|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | 1 of 3 | 3 of 5 | 0 of 3 | 19 of 40 | 0 of 4 |
| Neutrophils/Granulocytes (ANC/AGC) | Investigations | 1 of 3 | 3 of 5 | 0 of 3 | 14 of 40 | 0 of 4 |
| White Blood Cells/Leukocytes | Investigations | 1 of 3 | 3 of 5 | 0 of 3 | 12 of 40 | 0 of 4 |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | 2 of 3 | 1 of 5 | 0 of 3 | 11 of 40 | 0 of 4 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 3 | 1 of 5 | 0 of 3 | 11 of 40 | 0 of 4 |
| Lymphocytes | Investigations | 0 of 3 | 2 of 5 | 0 of 3 | 11 of 40 | 0 of 4 |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | 0 of 3 | 3 of 5 | 0 of 3 | 8 of 40 | 0 of 4 |
| Diarrhea | Gastrointestinal disorders | 1 of 3 | 1 of 5 | 0 of 3 | 8 of 40 | 0 of 4 |
| Fatigue | General disorders | 1 of 3 | 1 of 5 | 0 of 3 | 7 of 40 | 0 of 4 |
| AST, SGOT | Investigations | 0 of 3 | 1 of 5 | 0 of 3 | 8 of 40 | 0 of 4 |
Serious events with the highest arm-level rate: arrhythmia supraventricular (33.3%), fatigue (33.3%), hemoglobin decreased/anemia (33.3%), hypotension (33.3%), laboratory test abnormal (20.0%).
The serious adverse event record reports, by listed group, the number at risk and the number affected. The counts are: Phase 1 at Paclitaxel 80 mg/m2 plus Dasatinib 100 mg, 3 at risk and 3 affected; Phase 1 at Paclitaxel 80 mg/m2 plus Dasatinib 150 mg, 5 at risk and 2 affected; Phase 1 at Paclitaxel 80 mg/m2 plus Dasatinib 70 mg, 3 at risk and 0 affected; Phase 2 at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg, 40 at risk and 11 affected; and No Arm Selected, 4 at risk and 0 affected.
These figures describe participants affected by serious adverse events as recorded in the registry. They do not indicate the number of separate events, their duration or severity beyond the serious-event classification, or whether investigators considered them related to treatment. The record also lists deaths by group, but does not report their causes, timing, or relationship to treatment. The dose cohorts are not randomized comparison arms, so their counts should not be read as evidence of relative safety across doses.
Selected serious-event terms are listed with percentages: Arrhythmia supraventricular, Fatigue, Hemoglobin decreased/Anemia, and Hypotension are each listed as 33.3%; Laboratory test abnormal and Serum phosphate decreased are each listed as 20.0%. The denominator, cohort assignment, and whether these are participant-level percentages are not reported in the registry record. They should therefore be read as registry-listed descriptive percentages, not as cohort-specific risks.
12. What the Result Does, and Does Not, Mean
The record supports a clear description of the study question and design: a Phase I–II investigation of dasatinib with weekly paclitaxel in metastatic breast carcinoma, with dose escalation followed by a Phase II response assessment. It also provides selected serious adverse event counts by listed group and names several serious-event terms with associated percentages.
It does not provide the primary objective-response result. The count of complete and partial responses, the response proportion, and its uncertainty are not reported in the registry record. As a result, the posted information cannot quantify the response observed in the study or show how precise that estimate was. The record also does not provide numerical results for the listed survival, progression, or biomarker outcomes.
The design limits what any within-study comparison could establish. This was a single-group study, and its Phase I dose cohorts were part of a dose-finding process rather than randomized treatment and control arms. A comparison of counts across those cohorts would not isolate the effect of dose or regimen. No control-group estimate is recorded.
The safety counts are descriptive and do not, on their own, establish causation. The registry does not provide the event-level details, exposure time, or treatment-relatedness information needed to interpret them as comparative risks. Likewise, the separate death counts cannot be attributed to the study drugs from the information recorded.
The entry therefore conveys what the study set out to assess and some safety data, but not enough primary efficacy results or analysis detail for a full statistical evaluation. This absence should not be mistaken for a result showing either presence or absence of an effect; the primary result is simply not reported in the registry record.
13. Why This Trial Matters Statistically
This study illustrates the statistical distinction between dose finding and efficacy assessment. In Phase I, dose escalation is intended to inform selection of a dose for later study. The record describes a three-patient-per-cohort schedule and a goal of determining the maximum tolerated dose of dasatinib with weekly paclitaxel. Phase II then posed a different question: whether the selected combination produced complete or partial responses. These aims call for different interpretations and should not be collapsed into a single comparison of dose groups.
The registry also highlights why a defined endpoint is not enough to assess a result. The primary outcome is clearly named as a count of participants with objective response, and its timeframe is given. But without the response count, denominator details, and uncertainty estimate, readers cannot assess the observed frequency or precision. Clear outcome definitions are essential, while complete numerical reporting is necessary to interpret findings.
Population accounting matters as well. The record says the 3 Phase I participants at the Phase II dose were included in the Phase II group of 40. Recognizing this overlap prevents treating them as a separate additional group. The absence of complete analysis-population and missing-data details leaves uncertainty about how outcomes were handled across the study.
Finally, the design cautions against treating dose cohorts as control arms. Safety counts are useful descriptive information, but without randomization and fuller event context they do not establish comparative risks. Taken together, these features make the registry a useful account of the study’s structure and selected safety reporting, while underscoring the importance of posting outcome estimates, analysis methods, and uncertainty to support statistical interpretation.
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 limitation for interpreting efficacy is that the primary endpoint result is not reported in the registry record. The objective-response count, response proportion, and confidence interval are absent. Response criteria and assessment procedures are also not described, so the endpoint’s operational details cannot be reviewed.
The study is registered as single-group and has no masking. It therefore lacks a randomized control comparison, and the Phase I dose cohorts should not be treated as if they were exchangeable treatment arms. The registry gives a Phase II Simon two-stage design label, but its full stage rules and decision criteria are not reported. The Phase II arm description is incomplete.
The registry’s primary population description says that the 3 Phase I participants at Paclitaxel 80 mg/m2 plus Dasatinib 120 mg were included among the 40 Phase II participants. It does not give a complete account of analysis populations across all cohorts. Missing-data methods, follow-up details, survival censoring rules, and sensitivity analyses are not reported in the registry record.
For safety, the record provides participant counts affected by serious adverse events and selected term percentages, but does not specify event timing, duration, treatment relationship, or the denominator and cohort context for the term percentages. Death counts are listed without causes or attribution. These limits constrain interpretation of the safety information and prevent comparative risk conclusions.
Finally, the registry lists secondary outcomes but does not report their numerical results or analytic methods. It does not report a sample-size justification or whether multiplicity was addressed. These gaps restrict assessment of precision, robustness, and the relationship between the registered plan and the analyses performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194 — NCT00820170.
- Registry record last updated 2019-08-13; status last verified 2018-08.
- Results first posted 2019-08-13.
- 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
This completed Phase I–II, single-group study evaluated dasatinib in combination with weekly paclitaxel in metastatic breast carcinoma. The registry lists Memorial Sloan Kettering Cancer Center as sponsor, enrollment of 55, a recorded start of 2009-01, and primary completion of 2018-08.
Phase I used a three-patient-per-cohort dose-escalation approach to identify a maximum tolerated dose. Phase II is described as using a Simon two-stage design, and its listed dose combination was Paclitaxel 80 mg/m2 plus Dasatinib 120 mg. The primary endpoint was the count of participants with complete or partial response through study completion, up to 2 years. The registry record states that the 3 Phase I participants treated at that dose were included among the 40 Phase II participants.
The primary response result and numerical results for the listed secondary outcomes are not reported in the registry record. Selected serious adverse event counts and term percentages are present, but key context for interpreting them is absent. The available entry therefore documents the study’s aims, structure, and some safety information without reporting the primary efficacy estimate.