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 Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer (NCT00546364), a randomized phase 2 study. The primary outcome is Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00546364 |
| Phase | Phase 2 |
| Condition | Breast Neoplasms |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 62 |
| Arms in the primary outcome | n/a |
| Lead sponsor | R-Pharm |
| Results posted | Yes |
2. Clinical Question
Population
Women with metastatic breast cancer were the intended population. The primary outcome population is described as participants with measurable disease, a correct cancer diagnosis, and any treatment received. The registry record does not report further eligibility details or the number meeting this outcome definition.
Intervention
One study regimen combined ixabepilone at 40 mg/m^2 with capecitabine at 1000 mg/m^2. A second used ixabepilone at 32 mg/m^2 with capecitabine at 1000 mg/m^2. The registry record does not describe the rationale for the two ixabepilone dose regimens.
Comparator
The comparator regimen combined docetaxel at 75 mg/m^2 with capecitabine at 1000 mg/m^2. The study was randomized and used a parallel design, but the registry record does not report the allocation ratio or details of the randomization procedure.
Primary question
The primary outcome asks how many participants in each regimen group had each best tumor response category, as assessed by the investigator using RECIST. Categories include complete response, partial response, stable disease, and progressive disease. The registry record does not report the response counts or a statistical comparison of the regimens.
3. Trial Design
This was a randomized phase 2 study with a parallel-group design and no masking. It enrolled 62 participants. The registry record identifies three regimens: ixabepilone at 40 mg/m^2 plus capecitabine at 1000 mg/m^2, ixabepilone at 32 mg/m^2 plus capecitabine at 1000 mg/m^2, and docetaxel at 75 mg/m^2 plus capecitabine at 1000 mg/m^2. The recorded group sizes were 20 for docetaxel, 22 for ixabepilone 32, and 20 for ixabepilone 40.
The registry record gives a start date of 2008-02 and a primary completion date of 2010-03. The study status is terminated. The reason for termination is not reported in the registry record. The record does not report whether enrollment ended as planned, whether the planned follow-up was completed, or whether the study stopped early for a particular reason.
With no masking, participants and study personnel were not blinded according to the registry entry. This matters for interpretation because the primary tumor status was assessed by the investigator. Randomization can help balance factors between treatment groups, but the record does not describe the sequence generation, concealment, or allocation ratio. The arm descriptions contain no additional details about treatment delivery.
The study included a primary RECIST tumor-response outcome and several secondary outcomes. These included response by triple-negative and nontriple-negative status, safety events and laboratory abnormalities, time to progression, duration of response, and median number of treatment cycles. The registry record lists 10 outcome measures overall. It does not provide outcome results for the primary response categories or the secondary outcomes in the record, and it lists 0 analyses.
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: Of 62 participants enrolled, 62 were randomized and received treatment. Investigators had to terminate the study because an adequate number of participants could not be enrolled.
Overall Study
| Stage | Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 |
|---|---|---|---|
| STARTED | 20 | 22 | 20 |
| Never Treated | 0 | 0 | 0 |
| COMPLETED | 3 | 4 | 3 |
| NOT COMPLETED | 17 | 18 | 17 |
Reasons for not completing this period:
| Reason | Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 |
|---|---|---|---|
| Disease progression | 5 | 11 | 8 |
| Completed and off treatment | 1 | 0 | 2 |
| Administrative reason by sponsor | 1 | 0 | 0 |
| Poor compliance/noncompliance | 0 | 0 | 1 |
| No longer meets study criteria | 1 | 1 | 0 |
| Withdrawal by Subject | 5 | 6 | 3 |
| Prior taxotere | 1 | 0 | 0 |
| Mixed response | 1 | 0 | 0 |
| Palliative treatment | 1 | 0 | 1 |
| Target lesions resected | 1 | 0 | 0 |
| Physician Decision | 0 | 0 | 1 |
| Sponsor decision | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
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 | Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Total |
|---|---|---|---|---|---|
| Participants analysed | 20 | 22 | 20 | 62 | |
| Age, Continuous | years | 55.5 (32 to 68) | 59 (39 to 79) | 55.5 (33 to 65) | 57.5 (32 to 79) |
| Sex: Female, Male: Female | Participants | 20 | 22 | 20 | 62 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 4 | 4 | 13 |
| Race (NIH/OMB): White | Participants | 15 | 18 | 16 | 49 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST), measured over Baseline to 6 weeks (end of Cycle 2).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants in each best tumor response category, assessed using RECIST. The timeframe is baseline to 6 weeks, at the end of Cycle 2. The listed categories are complete response, partial response, stable disease, and progressive disease. In the registry definitions, complete response means disappearance of all nontarget lesions. Partial response requires at least a 30% reduction in the sum of the longest diameters of target lesions relative to baseline. Stable disease means neither the partial-response nor progressive-disease criteria are met. Progressive disease requires at least a 20% increase relative to the smallest recorded sum at or following baseline. Tumor status was assessed by the investigator.
General: A categorical tumor-response endpoint can describe the distribution of observed responses without treating all changes in tumor status as equivalent. It can distinguish participants whose disease meets the stated response criteria from those with stable or progressive disease. The result is a count by category, not by itself a complete account of how long a response lasts or how long participants remain without progression. Those questions are addressed by separate time-to-progression and duration-of-response outcomes in the registry.
The endpoint is clinically interpretable as a measure of tumor status over the specified assessment period, but interpretation still depends on the response counts and on how participants with missing assessments or no evaluable follow-up were handled. Those details, along with the actual category counts, are not reported in the registry record. The primary endpoint therefore defines what was to be measured, but the record does not establish the observed response distribution or a comparison between regimens.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the trial compared three combination regimens in a randomized, parallel design. It also specifies an investigator-assessed RECIST outcome from baseline to 6 weeks, at the end of Cycle 2. However, it does not report the number of participants in each best-response category. Without those counts, the primary outcome cannot be described by treatment group, and no difference in response distribution can be assessed from the registry entry.
No effect estimate, confidence interval, or p value for the primary endpoint is reported in the registry record. The record lists 0 analyses. Consequently, it does not establish whether the observed response categories differed across groups, how large any difference might have been, or how precisely an effect was estimated. This absence should not be read as evidence that the regimens had the same outcomes; it means the posted record does not give the results needed to make that statistical assessment.
The safety information is more specific. Serious adverse event counts are reported for each group: 5 of 20 participants in the docetaxel group, 5 of 22 in the ixabepilone 32 group, and 7 of 20 in the ixabepilone 40 group. Other adverse-event counts are 20 of 20, 22 of 22, and 20 of 20, respectively. These are descriptive counts. The registry entry does not report a statistical comparison of safety outcomes or provide enough information to infer whether group differences are attributable to the regimens.
The serious-event terms listed most often include dehydration and febrile neutropenia at 10.0% each, diarrhoea at 9.1%, and blood creatinine increased, neutrophil count decreased, and embolism at 5.0% each. These percentages are posted event-term summaries, not a comparative estimate of overall safety. The registry record does not specify in this summary whether a participant could contribute to more than one term or give the group-specific distribution for each listed term.
Other outcomes were intended to describe response by triple-negative status, laboratory abnormalities, time to progression, duration of response, and treatment cycles. Their results are not reported in the registry record. The status is terminated, but the reason and its implications for the planned analyses are not reported. Overall, the record supports a description of the design, endpoint definition, and selected safety counts, but not a conclusion about comparative efficacy or a complete benefit-risk assessment.
9. Statistical Methods Explained
The registry describes a randomized, parallel phase 2 study with no masking. The planned comparison involved three regimens, two using different ixabepilone doses with capecitabine and one using docetaxel with capecitabine. Randomization is a design method intended to reduce systematic differences between treatment groups at assignment. General: its value depends on adequate implementation and follow-up, and it does not ensure that every characteristic will be balanced in a modest-sized study. The registry record does not report the randomization procedure, allocation concealment, or allocation ratio.
What does the primary endpoint count?
The primary outcome is a count of participants classified by best tumor response under RECIST. The categories have different meanings: complete response, partial response, stable disease, and progressive disease. The endpoint description defines the response rules and identifies investigator assessment. The timeframe is baseline to 6 weeks, at the end of Cycle 2. The record does not give the category counts, the number assessed, or a comparison across groups.
General: categorical endpoints retain distinctions between possible outcomes rather than reducing them to a single measurement. A statistical comparison could assess whether the response distribution differs between groups, but the appropriate method depends on the planned analysis and the data structure. The registry record does not report the statistical test, model, or contrast used for the primary outcome. No method should be inferred from the endpoint definition alone.
How should counts and percentages be read?
The primary outcome is specified as a number of participants, and the adverse-event summaries include counts among participants at risk. A count gives the observed number in a group, while a percentage expresses a count relative to a denominator. When denominators differ, counts and percentages can convey different aspects of the data. General: a percentage can make groups easier to compare descriptively, but it does not account for uncertainty or establish that a difference is meaningful. The registry record does not report confidence intervals or hypothesis tests for the listed adverse-event figures.
For safety, the recorded serious-event counts are 5 of 20 in the docetaxel group, 5 of 22 in the ixabepilone 32 group, and 7 of 20 in the ixabepilone 40 group. The other adverse-event counts are 20 of 20, 22 of 22, and 20 of 20, respectively. These figures describe participants affected in the recorded groups; they do not give event duration, severity distributions beyond the listed serious-event classification, or exposure-adjusted rates. The registry record does not report those details.
What would an estimate and confidence interval add?
General: an effect estimate summarizes the size and direction of a comparison, while a confidence interval describes the statistical uncertainty around that estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, but neither an estimate nor its interval alone resolves questions about study conduct, missing data, or clinical importance. The registry record reports no primary endpoint estimate or confidence interval, so the precision of any response comparison cannot be evaluated.
For event counts, uncertainty can be substantial when groups are small or when events are uncommon. General: over-dispersion matters when observed variation is greater than a model assumes; a model that ignores it can understate uncertainty. This is a general statistical consideration, not a claim that over-dispersion occurred in this trial. The record does not report a model for the primary outcome or safety data, so there is no basis to assess whether such a feature was evaluated.
What can the status and analysis listing tell us?
The study status is terminated, and the record lists 0 analyses. Those details do not explain why the study ended or whether any analysis was conducted outside the registry. The reason for termination and the analysis plan are not reported in the registry record. It is therefore not possible to determine whether analyses were planned at interim time points, whether any stopping rule was used, or whether the reported status reflects a particular statistical decision.
The registry lists 10 outcome measures, including response subgroups, safety outcomes, laboratory findings, time to progression, duration of response, and treatment cycles. General: multiple outcomes create multiple opportunities to identify apparently notable findings. A prespecified hierarchy, adjustment method, or clear distinction between primary and exploratory outcomes can help readers interpret this multiplicity. The registry record does not report the multiplicity strategy, and the absence of analyses means no adjusted or unadjusted statistical results can be evaluated.
What does a planning calculation mean?
General: sample-size planning asks how many participants would be needed to detect an effect of a chosen size under specified assumptions. Such calculations are planning illustrations, not evidence that a trial had a particular probability of detecting an effect after it was completed. The registry record does not report the study's sample-size justification, target effect, or statistical power calculation. No sample-size rationale or observed-power conclusion can be derived from the enrollment alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures, including the primary tumor-response outcome and secondary measures covering response by triple-negative status, safety, laboratory results, time to progression, duration of response, and treatment cycles. Multiple outcomes can yield different kinds of findings and can increase the chance of apparently notable results when many statistical comparisons are made. General: a prespecified hierarchy or multiplicity adjustment can help control how results from multiple tests are interpreted. The registry record does not report a hierarchy, adjustment procedure, or other multiplicity strategy.
The record lists 0 analyses and gives no primary endpoint results, statistical tests, or analysis estimates. Whether interim analyses were planned or conducted is not reported in the registry record. The statistical analysis plan, including any prespecified models or contrasts, is not reported in the registry record. No conclusion about confirmatory versus exploratory testing can therefore be drawn from the outcome list alone.
The primary endpoint population is described as participants with measurable disease, a correct cancer diagnosis, and any treatment received. The registry does not report the number included in this population, the number excluded from analysis, or how treatment discontinuation or incomplete assessments were handled. Missing-data methods, imputation, and sensitivity analyses are not reported in the registry record. It is also not reported whether the primary analysis followed randomized assignment or used another analysis population.
These omissions matter because outcome classification may depend on having an assessment at the specified time, and analyses may differ depending on how missing assessments are handled. General: excluding participants with missing outcomes can change the composition of the analysis group, while imputation requires assumptions about unobserved values. The record does not provide enough detail to judge the direction or extent of any such effects.
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 |
|---|---|---|---|
| Docetaxel | 5 | 20 | 25.0% |
| Ixabepilone 32 | 5 | 22 | 22.7% |
| Ixabepilone 40 | 7 | 20 | 35.0% |
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 |
|---|---|
| Docetaxel | 20 of 20 |
| Ixabepilone 32 | 22 of 22 |
| Ixabepilone 40 | 20 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | Docetaxel | Ixabepilone 32 | Ixabepilone 40 |
|---|---|---|---|---|
| DEHYDRATION | Metabolism and nutrition disorders | 1 of 20 | 1 of 22 | 2 of 20 |
| DIARRHOEA | Gastrointestinal disorders | 0 of 20 | 2 of 22 | 1 of 20 |
| HYPOKALAEMIA | Metabolism and nutrition disorders | 0 of 20 | 1 of 22 | 1 of 20 |
| NEUTROPENIA | Blood and lymphatic system disorders | 1 of 20 | 1 of 22 | 0 of 20 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | 2 of 20 | 0 of 22 | 0 of 20 |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | 0 of 20 | 1 of 22 | 1 of 20 |
| BLOOD CREATININE INCREASED | Investigations | 0 of 20 | 0 of 22 | 1 of 20 |
| NEUTROPHIL COUNT DECREASED | Investigations | 0 of 20 | 0 of 22 | 1 of 20 |
| EMBOLISM | Vascular disorders | 0 of 20 | 0 of 22 | 1 of 20 |
| HYPOTENSION | Vascular disorders | 1 of 20 | 0 of 22 | 0 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Docetaxel | Ixabepilone 32 | Ixabepilone 40 |
|---|---|---|---|---|
| FATIGUE | General disorders | 12 of 20 | 17 of 22 | 15 of 20 |
| NAUSEA | Gastrointestinal disorders | 10 of 20 | 17 of 22 | 8 of 20 |
| DIARRHOEA | Gastrointestinal disorders | 8 of 20 | 12 of 22 | 9 of 20 |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | 8 of 20 | 12 of 22 | 8 of 20 |
| CONSTIPATION | Gastrointestinal disorders | 5 of 20 | 7 of 22 | 12 of 20 |
| NEUTROPENIA | Blood and lymphatic system disorders | 11 of 20 | 5 of 22 | 5 of 20 |
| ALOPECIA | Skin and subcutaneous tissue disorders | 4 of 20 | 10 of 22 | 6 of 20 |
| DECREASED APPETITE | Metabolism and nutrition disorders | 6 of 20 | 7 of 22 | 6 of 20 |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | 3 of 20 | 8 of 22 | 7 of 20 |
| VOMITING | Gastrointestinal disorders | 4 of 20 | 8 of 22 | 6 of 20 |
Serious events with the highest arm-level rate: dehydration (10.0%), febrile neutropenia (10.0%), diarrhoea (9.1%), blood creatinine increased (5.0%), neutrophil count decreased (5.0%).
The registry reports serious adverse event counts and other adverse-event counts for each treatment group. Serious events were recorded for 5 of 20 participants in the docetaxel group, 5 of 22 in the ixabepilone 32 group, and 7 of 20 in the ixabepilone 40 group. Other adverse events were recorded for 20 of 20, 22 of 22, and 20 of 20 participants, respectively. These are group-level counts, not comparative statistical estimates.
The listed serious-event terms include dehydration and febrile neutropenia at 10.0% each, diarrhoea at 9.1%, and blood creatinine increased, neutrophil count decreased, and embolism at 5.0% each. The registry record does not show the group-specific counts for each term in this summary, nor does it report whether participants could appear under multiple terms. The percentages should therefore be read as descriptive term summaries, not as mutually exclusive categories or as a complete account of each participant's experience.
General: adverse-event counts do not by themselves account for exposure duration, event severity beyond the stated classification, or uncertainty in comparisons. The record does not provide a statistical safety comparison, exposure-adjusted rates, or a death count; the death field is not populated. A missing death count should not be interpreted as evidence that no deaths occurred. The figures describe what the registry reports and do not establish a causal relationship between a regimen and an event.
12. What the Result Does, and Does Not, Mean
The registry record shows that a randomized phase 2 study was designed to evaluate three combination regimens in metastatic breast cancer. Its primary outcome was best tumor response under RECIST from baseline to 6 weeks, at the end of Cycle 2. The response categories and their criteria are defined, and the investigator assessed tumor status. This establishes what the primary outcome was intended to capture.
The record does not report the numbers of participants in the response categories, an effect estimate, a confidence interval, or a p value. It therefore does not show the observed primary response distribution or quantify a comparison among regimens. This lack of posted efficacy results does not show that the treatments were equivalent, that one was better, or that no effect occurred. Those interpretations require results and an analysis that are not reported in the registry record.
The available safety figures give descriptive counts of participants with serious and other adverse events. They do not constitute a randomized comparison with uncertainty estimates, and the record does not report sufficient detail to connect individual event terms to particular treatment groups. The figures also do not account for exposure duration or establish causation. They should not be treated as a complete safety profile.
The secondary outcomes include response by triple-negative status, time to progression, duration of response, laboratory abnormalities, and treatment cycles. Their results are not reported in the registry record. The study status is terminated, but the reason is not reported. Together, these gaps limit interpretation of both the planned outcomes and the conduct of the study.
General: a trial's design tells readers what comparisons were intended, while outcome data and statistical analyses are needed to assess what was observed and how precisely it was estimated. In this record, the design and outcome definitions can be described, but the evidence needed to characterize comparative efficacy is absent. No treatment recommendation or conclusion about whether a regimen works follows from these registry entries alone.
13. Why This Trial Matters Statistically
This trial is statistically notable for having three randomized treatment groups and a categorical primary outcome, while the registry record does not include the response results or analyses. That combination illustrates an important distinction: a protocol-level endpoint definition is not the same as a posted result. RECIST criteria explain how tumor status was classified, but without the category counts there is no basis to describe the observed response pattern or estimate a treatment contrast.
The recorded group sizes are 20 for docetaxel, 22 for ixabepilone 32, and 20 for ixabepilone 40, within total enrollment of 62. General: with limited group sizes, estimates may be imprecise, particularly for less common outcomes. Precision must be assessed from estimates and uncertainty intervals, which are not reported for the primary endpoint. Enrollment alone cannot establish statistical power or show what effect the study could reliably detect.
The safety record demonstrates why descriptive counts also need careful context. Serious-event counts are present, but no comparative analysis or uncertainty measure is reported. The lists of event terms and percentages add detail, yet they do not substitute for group-specific event distributions or exposure information. General: an observed count can be informative for describing what was recorded, while remaining insufficient to distinguish chance variation from a treatment-related difference.
The terminated status and absence of listed analyses also leave questions about completion and analysis decisions unresolved. The reason for termination, analysis plan, handling of missing data, and any interim analyses are not reported in the registry record. These are not minor details when assessing whether available findings address the originally intended question. The case underscores that transparent outcome reporting and analysis documentation are necessary for readers to evaluate both the size and reliability of clinical-trial findings.
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 principal limitation for interpreting this trial is that the registry record defines the primary RECIST endpoint but does not report its category counts or any statistical comparison. There is consequently no posted estimate of the primary response outcome and no measure of its precision. The record also lists 0 analyses, so it does not supply inferential results for the primary or secondary outcomes.
The study status is terminated, but the reason for termination is not reported in the registry record. It is not possible to determine from the listed details whether the planned recruitment, follow-up, or analyses were completed. The registry does not report a sample-size justification, target effect, or power calculation, and enrollment alone cannot establish whether the study was designed to detect a particular difference.
The record describes the primary outcome population but does not report how many participants met that definition or how missing or unevaluable responses were handled. The analysis population, missing-data methods, and sensitivity analyses are not reported in the registry record. Details of randomization, allocation concealment, and allocation ratio are also not reported, limiting assessment of how assignment was implemented.
The safety summaries provide counts and selected event-term percentages, but no comparative estimates, confidence intervals, exposure-adjusted rates, or complete group-specific breakdown for the listed serious-event terms. The death field is not populated, and no conclusion about deaths can be drawn from that absence. The record also does not report results for the listed secondary outcomes, including time to progression and duration of response.
Finally, no multiplicity strategy, interim-analysis plan, or statistical analysis plan is reported in the registry record. These limitations do not demonstrate that the study lacked such procedures; they mean the registry entry does not document them. Interpretation must remain limited to the design, endpoint definitions, status, and descriptive safety counts that are recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer — NCT00546364.
- Registry record last updated 2016-03-10; status last verified 2016-02.
- Results first posted 2011-06-01.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT00546364 is a randomized, open-label, parallel phase 2 study of ixabepilone plus capecitabine or docetaxel plus capecitabine in metastatic breast cancer. Total enrollment was 62. The recorded groups were docetaxel, ixabepilone 32, and ixabepilone 40. The study began in 2008-02, reached primary completion in 2010-03, and is listed as terminated.
The primary outcome is the number of participants in each best RECIST tumor-response category, assessed by the investigator from baseline to 6 weeks, at the end of Cycle 2. The registry record does not report the response counts or a statistical comparison. It lists 10 outcome measures and 0 analyses. Serious adverse event counts were 5 of 20, 5 of 22, and 7 of 20 across the three groups, respectively. The reason for termination, analysis plan, and primary outcome results are not reported in the registry record.