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 Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer (NCT00050167), a randomized phase 1 study. The primary outcome is Percentage of Participants With Reoccurrence.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00050167 |
| Phase | Phase 1 |
| Condition | Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 603 |
| Arms in the primary outcome | 2 |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Participants with operable breast cancer. The registry reports an enrollment of 603 and identifies the condition as breast cancer. It does not report further eligibility details in the record summarized for this analysis.
Intervention
The DX regimen began with docetaxel plus capecitabine on days 1–14 every 3 weeks for 4 cycles, followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) for 4 cycles.
Comparator
The WP regimen consisted of weekly paclitaxel for 12 weeks, followed by FEC every 3 weeks for 4 cycles. The registry describes the study as randomized, with parallel groups and no masking.
Primary question
The registry’s primary objective was to compare the regimens on a recurrence-related endpoint. Its description defines an event as local recurrence, distant metastasis, or death from any cause by 50 months. The registry also lists disease-free and overall survival among the broader primary objectives, as well as objectives concerning downstaging and breast conservation in the neoadjuvant setting.
The central statistical question is whether the posted results allow a clear comparison of recurrence outcomes between the two treatment sequences. The record gives an endpoint value and a 95% confidence interval for each arm, but does not post a direct between-arm estimate, confidence interval, or p-value. The endpoint label and description also leave uncertainty about how to interpret the direction of the reported percentages. Those details matter: a percentage described as participants with recurrence-related events has a different meaning from a percentage remaining free of those events. The arm values alone do not resolve that ambiguity.
The registry’s other objectives broaden the clinical questions beyond recurrence. They include the effect of each regimen on disease-free and overall survival, and whether docetaxel/capecitabine can downstage primary disease or enhance breast conservation when given before surgery. Pathological complete response and tumor eradication in the breast and lymph nodes are listed among secondary outcomes. The posted information does not establish that results for all these objectives are available.
3. Trial Design
The registry describes NCT00050167 as a completed, randomized, parallel-group study with no masking. It lists the phase as PHASE1 and records an enrollment of 603. The sponsor was M.D. Anderson Cancer Center. The registry gives a start date of 2002-11 and a primary completion date of 2008-07.
Two treatment groups are described. In the WP group, participants received weekly paclitaxel for 12 weeks, then FEC every 3 weeks for 4 cycles. In the DX group, participants received docetaxel plus capecitabine on days 1–14 every 3 weeks for 4 cycles, then FEC for 4 cycles. The listed interventions are paclitaxel, docetaxel, and capecitabine; FEC is also specified in the arm descriptions.
Randomization is the design feature intended to make treatment allocation independent of participants’ measured and unmeasured characteristics, on average. General: when allocation is randomized, a comparison between assigned groups can support a causal interpretation more strongly than an observational comparison, provided the randomization and subsequent analyses are appropriately conducted. The registry record does not report the randomization procedure, allocation concealment, or any stratification factors, so those features cannot be assessed from the posted information.
The record identifies 301 participants in the WP intent-to-treat analysis and 300 in the DX intent-to-treat analysis. The safety analysis populations are 297 in WP and 292 in DX. These analysis counts are not the same as the registry’s overall enrollment of 603. Reasons for the difference between enrollment and the reported analysis populations are not reported in the registry record.
The record identifies the study as unmasked. It does not report whether outcome assessors were masked, how treatment adherence was handled, or whether participants changed regimens. Nor does it report detailed eligibility criteria, the planned follow-up schedule, or how the study was categorized as PHASE1 despite the comparative treatment objectives. These omissions limit interpretation of the trial’s implementation and context.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Planned accrual was 930 participants, only 601 were found eligible.
Overall Study
| Stage | Weekly Paclitaxel (WP) | Docetaxel and Capecitabine (DX) |
|---|---|---|
| STARTED | 302 | 301 |
| COMPLETED | 301 | 300 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Weekly Paclitaxel (WP) | Docetaxel and Capecitabine (DX) |
|---|---|---|
| not eligible not invasive | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: (WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis. (DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis.
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 | Weekly Paclitaxel (WP) | Docetaxel and Capecitabine (DX) | Total |
|---|---|---|---|---|
| Participants analysed | 302 | 301 | 603 | |
| Age Continuous | years | 50 (42 to 57) | 50 (42 to 57) | 50 (42 to 57) |
| Sex: Female, Male: Female | Participants | 302 | 301 | 603 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 302 | 301 | 603 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Reoccurrence, measured over Median of 50 months.
| Element | Registry entry |
|---|---|
| Result type | Log Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | participants |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Percentage of Participants With Reoccurrence.” The registry description defines the outcome as the number of participants with local recurrence, distant metastasis, or death from any cause at 50 months, divided by the total number of participants. It gives the timeframe as a median of 50 months. A combined endpoint of this kind can capture several clinically important ways in which a participant may experience an unfavorable outcome, rather than focusing only on one type of recurrence.
The registry reports 90.7% for WP, with a 95% confidence interval of 86.4% to 93.7%, and 87.5% for DX, with a 95% confidence interval of 82.7% to 91.1%. However, the label and description indicate a percentage with recurrence-related events, while the record does not clarify whether the displayed percentages represent event occurrence or freedom from those events. The values should therefore be quoted as posted rather than given a directional interpretation. Clarification of the endpoint coding and calculation is not reported in the registry record.
Even when the endpoint is clearly defined, a value for each arm does not by itself quantify the treatment contrast. A direct comparison would ordinarily specify an effect measure and its uncertainty, such as an estimated difference or ratio with a confidence interval, or a test of the between-arm hypothesis. Such a comparison is not posted in the registry record. The time horizon also matters: results summarized at a median of 50 months describe the stated follow-up context and should not be generalized to other follow-up durations.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports endpoint values of 90.7% for WP and 87.5% for DX. The associated 95% confidence intervals are 86.4% to 93.7% and 82.7% to 91.1%, respectively. These are arm-specific summaries. They do not constitute a direct estimate of the difference between treatment groups, and the record does not give a p-value or a confidence interval for a between-group contrast.
A central interpretive limitation is the endpoint’s direction. Its title refers to participants with reoccurrence, and its description says the percentage is based on participants with local recurrence, distant metastasis, or death. Yet the registry does not explain whether the posted percentages are event percentages or a complementary event-free measure. Without that clarification, it is not appropriate to say which arm had more recurrence-related events, or to characterize one value as favorable. The values and intervals can be reported faithfully, but the direction of the clinical comparison remains unclear.
The confidence intervals express uncertainty around each arm’s reported value under the analysis used. General: a confidence interval is a range generated by a statistical procedure that, under its assumptions, reflects the precision of an estimate. A narrower interval generally indicates greater precision than a wider one, but an arm-specific interval does not answer the same question as an interval for the contrast between arms. The registry does not report enough information to reconstruct or verify a comparative interval.
The outcome description refers to recurrence or death “at 50 months,” while the timeframe is stated as a median of 50 months. These phrases do not fully specify whether the reported percentage is a fixed-time risk, a time-to-event estimate, or another summary. The registry labels the endpoint parameter as LOG MEAN, but does not explain the calculation or its interpretation in the posted result. The statistical analysis details needed to resolve these points are not reported in the registry record.
There are also limits to what can be inferred from the analysis populations. Intent-to-treat counts are 301 in WP and 300 in DX, while the safety counts are 297 and 292. The registry does not explain how participants without a posted analysis result were handled, whether follow-up was complete, or whether the endpoint analysis included all participants assigned to a group. Those details can affect how an estimate should be interpreted, particularly for a recurrence-related outcome with a defined follow-up horizon.
The registry lists disease-free and overall survival as objectives and includes pathological complete response and tumor eradication as secondary outcomes. It records 3 outcome measures and 0 analysis records. The posted endpoint summaries therefore should not be treated as a complete account of all stated objectives, nor as evidence that every listed outcome was analyzed or reported. No trial-specific inferential statistical plan, adjustment strategy, or interim analysis information is reported in the registry record.
Overall, the posted data establish the arm-specific values and their stated confidence intervals, but do not support a clear conclusion about the comparative recurrence result. The uncertainty concerns both the absence of a direct treatment contrast and the unclear direction of the endpoint percentages. These limits are about what the registry reports; they do not establish what analyses may have been conducted elsewhere.
9. Statistical Methods Explained
The record describes a randomized, parallel-group comparison without masking. In a parallel-group design, participants are assigned to one treatment sequence and followed in that group rather than crossing over between the regimens. Random allocation is intended to reduce systematic differences between groups at the start of a study. General: randomization does not guarantee that every characteristic will be identical between groups, especially in a finite study, but it provides a basis for comparing outcomes by assigned group when the analysis preserves that allocation and handles missing outcomes appropriately. The registry record does not describe the randomization method or the analysis procedures in enough detail to assess those conditions.
The main posted result is an arm-specific percentage with a 95% confidence interval. General: an estimate is a summary of the data, while its confidence interval describes the precision of that estimate under the statistical model and assumptions used. A confidence interval does not indicate the probability that a particular treatment is better, and separate intervals for two arms do not replace a direct interval for their contrast. Here, the registry gives intervals for WP and DX but does not report a treatment-effect estimate, its confidence interval, or a p-value. No comparative significance claim can be drawn from the posted summaries alone.
Endpoint definition is as important as the estimation method. The registry title names the outcome as the percentage of participants with reoccurrence. Its description includes local recurrence, distant metastasis, or death from any cause at 50 months, and the timeframe is a median of 50 months. But the record does not clarify whether the reported percentages are the proportion experiencing an event or a proportion free of events. It also does not specify whether the endpoint was analyzed as a fixed-time proportion or through a time-to-event method. That uncertainty affects the meaning of the direction of the arm values.
General: a fixed-time proportion summarizes the fraction of participants experiencing an outcome by a specified time, whereas a time-to-event analysis uses the timing of events and can account for differing follow-up under particular methods. Time-to-event analyses also require decisions about censoring and the handling of events that prevent the outcome of interest from occurring. The registry record does not report those analytic details for this endpoint. The label LOG MEAN is present, but no explanation is given of the estimator, transformation, or model that produced the posted values.
When events are counted over follow-up, participants may contribute different amounts of observation time. General: an analysis based on event times can use that timing information, while a simple proportion may not reflect unequal follow-up in the same way. The appropriate interpretation depends on the endpoint and analysis method. Because the registry does not identify the method used to obtain the posted percentages, one should not infer a survival curve, hazard ratio, event rate, or other statistic from them.
Over-dispersion is a general statistical concern when outcome variability exceeds what a chosen model assumes. If a model understates that variability, its standard errors may be too small and confidence intervals may be too narrow. This is a general consideration, not a finding about this trial: the registry does not identify a model or report an over-dispersion assessment. Likewise, the record does not report whether any covariate adjustment was used. Adjusted and unadjusted estimates can answer related but distinct questions, so the absent analysis description prevents evaluation of that choice.
The registry provides intent-to-treat population counts of 301 for WP and 300 for DX, and safety analysis counts of 297 and 292, respectively. General: an intent-to-treat approach analyzes participants in the groups to which they were assigned, regardless of treatment received, and is often used to preserve the benefits of randomization. The registry labels these populations but does not state how the endpoint analysis was conducted, how missing outcome data were handled, or whether the posted result follows an intent-to-treat principle. The safety counts are not a substitute for endpoint-specific analysis counts.
Multiple outcomes and objectives raise a general multiplicity issue. When several hypotheses are tested, the chance of at least one apparently positive result can increase if no adjustment or prespecified hierarchy is used. The registry lists disease-free and overall survival, downstaging, breast conservation, pathological complete response, and tumor eradication among its objectives or outcomes. It does not report a multiplicity strategy, a primary analysis hierarchy, or the number of statistical tests actually conducted. The count of 0 analysis records means no analysis records are posted in this registry record; it does not establish that no analyses were performed.
The record includes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such planning calculations are illustrations, not evidence of the trial’s original design or its achieved ability to detect an effect. The record explicitly does not characterize them as the trial’s own design. Sample-size illustrations are not observed power: they do not show the probability that the completed trial detected a true effect. No trial-specific sample-size justification is reported in the registry record.
General: a transparent report of a comparative trial would ordinarily describe the endpoint definition, estimator, analysis population, missing-data handling, contrast measure, uncertainty estimate, and any planned multiplicity control. These details are necessary to judge whether the result matches the study question and how robustly it was estimated. In this case, the registry posts arm-level values and confidence intervals but not those analytic specifications. Interpretations should therefore remain limited to the registry’s stated values and design information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several objectives: disease-free and overall survival, downstaging with docetaxel/capecitabine in the neoadjuvant setting, and enhancement of breast conservation in that setting. It also lists pathological complete response and tumor eradication in the breast and lymph nodes as secondary outcomes. Although 3 outcome measures are recorded, the registry shows 0 analysis records. It does not report a testing hierarchy, multiplicity adjustment, or which comparisons were prespecified as confirmatory.
General: testing several outcomes or treatment contrasts can increase the chance of at least one apparently unusual result arising by chance. A prespecified hierarchy or adjustment can help control that issue, but the suitable approach depends on the study’s aims and analysis plan. No such approach is reported in the registry record. The absence of posted analysis records also means that no multiplicity-adjusted or unadjusted test results for the stated outcomes can be evaluated.
The registry gives intent-to-treat counts of 301 for WP and 300 for DX, and safety populations of 297 and 292. It does not report why those populations differ from the overall enrollment of 603, or how participants who were not included in an analysis were handled. The endpoint description does not specify the amount of missing follow-up, the number censored, or any missing-data method. Those details are important for understanding whether the reported percentages represent the full randomized groups and how sensitive the result may be to incomplete outcome information.
The record also does not report protocol deviations, treatment discontinuation, crossover, or the handling of participants who did not receive the assigned regimen. These are not claims that such events occurred; they are analysis details not reported in the registry record. Without them, the population represented by the posted endpoint values cannot be fully characterized.
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 |
|---|---|---|---|
| Weekly Paclitaxel (WP) | 81 | 301 | 26.9% |
| Docetaxel and Capecitabine (DX) | 293 | 300 | 97.7% |
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 |
|---|---|
| Weekly Paclitaxel (WP) | 297 of 301 |
| Docetaxel and Capecitabine (DX) | 293 of 300 |
Most frequent serious adverse event terms
| Event term | Organ system | Weekly Paclitaxel (WP) | Docetaxel and Capecitabine (DX) |
|---|---|---|---|
| Fatigue | General disorders | 25 of 297 | 66 of 293 |
| Hand foot syndrome | Skin and subcutaneous tissue disorders | 1 of 297 | 54 of 293 |
| Myalgia | Musculoskeletal and connective tissue disorders | 19 of 297 | 32 of 293 |
| Neutropenia | Blood and lymphatic system disorders | 2 of 297 | 45 of 293 |
| Diarrhea | Gastrointestinal disorders | 12 of 297 | 17 of 293 |
| Neutropenic Infection | Infections and infestations | 2 of 297 | 20 of 293 |
| Peripheral Neurotoxicity | Nervous system disorders | 7 of 297 | 14 of 293 |
| Nausea | Gastrointestinal disorders | 5 of 297 | 12 of 293 |
| Neutropenic Fever | Infections and infestations | 0 of 297 | 13 of 293 |
| Constipation | Gastrointestinal disorders | 2 of 297 | 6 of 293 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Weekly Paclitaxel (WP) | Docetaxel and Capecitabine (DX) |
|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | 239 of 297 | 266 of 293 |
| fatigue | General disorders | 146 of 297 | 169 of 293 |
| Myalgias | Musculoskeletal and connective tissue disorders | 109 of 297 | 137 of 293 |
| Nausea | Gastrointestinal disorders | 64 of 297 | 131 of 293 |
| Stomatitis | Gastrointestinal disorders | 31 of 297 | 118 of 293 |
| Diarrhea | Gastrointestinal disorders | 55 of 297 | 85 of 293 |
| Peripheral Neurotoxicity | Nervous system disorders | 68 of 297 | 64 of 293 |
| Skin rash | Skin and subcutaneous tissue disorders | 77 of 297 | 43 of 293 |
| Constipation | Gastrointestinal disorders | 27 of 297 | 50 of 293 |
| Hand Foot Syndrome | Skin and subcutaneous tissue disorders | 5 of 297 | 72 of 293 |
Serious events with the highest arm-level rate: fatigue (22.5%), hand foot syndrome (18.4%), neutropenia (15.4%), myalgia (10.9%), neutropenic infection (6.8%).
The registry lists serious adverse event figures of 81 affected among 301 at risk in WP and 293 affected among 300 at risk in DX. It also lists other adverse event figures of 297 affected among 301 at risk in WP and 293 affected among 300 at risk in DX. These are the counts as recorded; no rates have been calculated. The registry does not explain the definitions, event-collection procedures, or analysis rules behind these entries.
The figures should not be interpreted as a direct treatment comparison without clarification of how “affected” was defined, whether the counts represent participants or events, and whether ascertainment was comparable between groups. The registry does not provide a comparative effect estimate or confidence interval for these safety outcomes. The striking difference between the serious adverse event counts warrants particular caution about interpretation, but the posted information does not identify its explanation.
The listed serious terms and percentages are fatigue (22.5%), hand foot syndrome (18.4%), neutropenia (15.4%), myalgia (10.9%), neutropenic infection (6.8%), and diarrhea (5.8%). The record does not specify which arm each percentage applies to, the denominator used, or whether the terms are mutually exclusive. Death counts for the safety groups are not reported in the registry record. These safety entries are descriptive registry data and do not by themselves establish comparative risk or causation.
12. What the Result Does, and Does Not, Mean
The registry records a randomized comparison of WP and DX treatment sequences and reports an arm-specific recurrence-related percentage with a 95% confidence interval for each group. Those entries document what the registry posts, but they do not provide a complete inferential comparison. There is no reported between-arm estimate, no confidence interval for a contrast, and no p-value in the registry record.
The direction of the percentages is unresolved. The endpoint title and description refer to recurrence-related events, but the record does not clarify whether the posted percentages represent participants with events or participants without events. For that reason, the numerical ordering of the arm values cannot be translated into a claim that one regimen had more or fewer events. The interpretation should remain descriptive until the endpoint coding and calculation are clarified.
General: a randomized design can support comparison of assigned groups, but causal interpretation still depends on the conduct of the trial, outcome measurement, completeness of follow-up, and the analysis. The registry does not report enough detail to evaluate all of those elements. Its designation as randomized is relevant, but it is not a substitute for information on allocation procedures, missing data, or the analysis population used for the endpoint.
The registry’s broader objectives include disease-free and overall survival, neoadjuvant downstaging, and breast conservation, with secondary outcomes concerning pathological complete response and tumor eradication. The endpoint summaries do not answer all of those questions. With 0 analysis records posted, the registry does not supply inferential analyses for those objectives in the record. Their omission should not be taken to mean that they were not assessed outside the registry.
The safety figures are also limited. They are affected counts without a reported comparative analysis, and the record does not describe their denominators beyond the at-risk group counts or explain the marked difference in serious adverse event entries. The serious-term percentages lack arm-specific attribution in the record. They should not be used to make causal or treatment-selection claims.
Accordingly, these registry results describe reported arm-level values, confidence intervals, analysis population counts, and safety entries. They do not establish which treatment sequence is preferable, whether the regimens differ statistically, or how the results should guide an individual’s care. Those conclusions require a clearly defined endpoint, a direct comparative analysis, and sufficient reporting of trial conduct and analysis.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry combines a randomized comparison with a primary endpoint whose interpretation is not fully clear from the posted description. The record names a percentage of participants with recurrence, defines the event components, and gives arm-level percentages and confidence intervals. Yet it does not clarify whether those percentages represent event occurrence or an event-free measure. That gap illustrates how endpoint wording and statistical coding jointly determine what a numerical result means.
The record also shows why arm-specific summaries should not be confused with an estimate of treatment effect. A value and confidence interval for each group can describe each group separately, but the comparative question concerns the difference between assigned regimens. The registry does not report that direct contrast. Without it, the treatment comparison cannot be assessed through a stated effect estimate and its precision.
Several research objectives are listed, including survival, neoadjuvant response, and breast conservation. Yet the registry records 0 analysis records. This emphasizes the importance of linking each objective to a clearly identified outcome, analysis population, and statistical result. It also prevents readers from assuming that a primary endpoint summary answers every question named in the study objectives.
The study is listed as randomized and unmasked, with separate intent-to-treat and safety counts. Those features make the analysis populations and handling of missing outcomes especially relevant to interpretation. The registry does not report why the counts differ, what happened to participants not included in each population, or how incomplete follow-up was addressed. These are central reporting details rather than minor technicalities.
Finally, the serious adverse event entries show that safety data also require clear definitions, denominators, and arm-specific interpretation. Counts alone, especially when their meaning is not fully explained, do not amount to a comparative safety analysis. Taken together, the record demonstrates that precise statistical interpretation depends not only on numerical results, but also on unambiguous endpoint definitions and transparent methods.
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 leaves several trial-specific questions unresolved. It identifies the endpoint as a percentage of participants with reoccurrence and describes local recurrence, distant metastasis, or death from any cause at 50 months. However, it does not clarify the direction of the displayed percentages or whether the estimate is a fixed-time proportion or a time-to-event summary. The listed median timeframe does not resolve that ambiguity.
Only arm-level values and confidence intervals are posted for the primary endpoint. No direct comparative estimate, p-value, or analysis record is available in the registry record. The analysis method, model, covariate adjustment, and confidence-interval procedure are not reported. Consequently, the precision and assumptions behind the posted values cannot be independently assessed from the record.
The registry reports 603 participants enrolled, with intent-to-treat counts of 301 in WP and 300 in DX, and safety counts of 297 and 292. Reasons for these differences are not reported. The record does not state how missing endpoint data, censoring, protocol deviations, treatment discontinuation, or other departures from assignment were handled. It also does not report the randomization procedure, allocation concealment, eligibility criteria, or masking of outcome assessment.
Several objectives and secondary outcomes are listed, but no analysis records are posted. The registry does not report a multiplicity plan or a hierarchy among outcomes. The serious adverse event counts and listed serious-term percentages also lack sufficient detail about definitions, denominators, and arm attribution to support a comparative safety interpretation. These reporting gaps limit conclusions from the registry entries and should not be mistaken for evidence that the relevant procedures or analyses were absent from the trial itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer — NCT00050167.
- Registry record last updated 2011-08-29; status last verified 2011-08.
- Results first posted 2011-08-05.
- 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
NCT00050167 is recorded as a completed, randomized, unmasked, parallel-group PHASE1 study sponsored by M.D. Anderson Cancer Center, with enrollment of 603. It compared weekly paclitaxel followed by FEC (WP) with docetaxel plus capecitabine followed by FEC (DX) in participants with operable breast cancer.
The primary endpoint is titled percentage of participants with reoccurrence and is described as including local recurrence, distant metastasis, or death from any cause at 50 months. The registry reports 90.7% for WP (95% confidence interval 86.4% to 93.7%) and 87.5% for DX (95% confidence interval 82.7% to 91.1%). The direction of these percentages is not clarified, and no direct treatment contrast or analysis record is posted.
The registry lists survival, neoadjuvant response, breast conservation, and tumor-eradication objectives. It reports intent-to-treat counts of 301 and 300, safety counts of 297 and 292, and serious adverse event affected counts of 81 and 293. Analysis methods, missing-data handling, and a multiplicity strategy are not reported in the registry record.