A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine (NCT00373113), a randomized phase 3 study. The primary outcome is Progression-Free Survival (PFS).

2. Clinical Question

The registry record describes NCT00373113 as a Phase III, randomized, parallel-group trial in advanced breast cancer. The clinical question was framed for participants whose disease had progressed after prior chemotherapy or who could not receive further anthracycline therapy. This makes the results specific to that treatment history and population; they should not be treated as an estimate for every person with breast cancer or every point in the course of the disease.

The primary endpoint brings together two events: objective tumor progression and death from any cause. That composite measure can capture both disease progression and death as clinically important events in the time-to-event analysis. The record also lists outcomes concerning tumor progression, response, survival, and quality of life, but progression-free survival is the designated primary endpoint. The statistical comparison therefore centers on the time from randomization until progression or death, rather than on response counts alone.

Randomization assigned 238 participants to sunitinib and 244 to capecitabine for the primary endpoint analyses. Those group counts describe the randomized comparison, not a guarantee that every participant contributed an event or the same length of follow-up. The registry record says the primary population included all randomized participants. Details about how individual follow-up or censoring was handled are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group Phase III study comparing two drug regimens. The registry record lists 482 participants enrolled. It records 238 participants in the sunitinib group and 244 in the capecitabine group for the primary endpoint. These are the analyzed group counts and reflect the intent-to-treat population described in the record: all participants who were randomized.

The sunitinib regimen was 37.5 mg daily with continuous dosing. Capecitabine was administered at 1250 mg/m^2 twice daily for 2 consecutive weeks, followed by a 1-week rest period, in 3-week cycles. The record specifies no masking: the study is listed as open label. Allocation is listed as randomized, and the model is parallel, meaning participants were assigned to one of the two groups rather than crossing between regimens as part of the listed design.

The study began in 2006-11, and primary completion is listed as 2009-10. Its status is recorded as terminated. The reason for termination is not reported in the registry record. The record does not describe a planned stopping rule, interim analysis, or the original rationale for the enrollment target. Those details cannot be inferred from the enrollment total or the recorded status.

The primary endpoint was progression-free survival, measured from randomization to objective tumor progression or death from any cause, whichever occurred first. The stated timeframe describes assessment from randomization at 6-week intervals through 22 months or until death. The registry record identifies the intent-to-treat population as the primary analysis population. It also lists secondary outcomes covering tumor progression, response, response duration, response timing, overall survival, and quality of life instruments.

Because the trial was unmasked, participants and study personnel were not blinded to assigned treatment according to the registry record. The record does not explain how this was considered in outcome assessment, nor does it report additional design safeguards or operational details. The comparison should therefore be read from the stated randomized design and posted analyses, without assuming unreported protocol features.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population: included all participants who were randomized.

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.

6. Primary Endpoint

The registry lists the primary outcome as Progression-Free Survival (PFS), measured over From time of randomization to every 6 weeks thereafter through 22 months or until death.

Progression-free survival measures the time from randomization until the first documented objective tumor progression or death from any cause, whichever happens first. In this trial, the registry record gives the assessment timeframe as every 6 weeks from randomization through 22 months or until death. It identifies all randomized participants as the intent-to-treat population for the primary endpoint.

This kind of endpoint is used in clinical trials because it represents time until a defined event, rather than a single assessment at a fixed visit. Combining progression and death means that either event can count as an endpoint event. This is a general description of the statistical concept; it does not establish how any individual participant’s follow-up was managed in this trial. Specific censoring rules and missing-assessment procedures are not reported in the registry record.

The posted results report median progression-free survival for each group and a hazard ratio from a log-rank analysis. A median describes the time by which half of the analyzed group is estimated to have experienced the endpoint event, under the time-to-event analysis. It does not describe the exact experience of every participant, and it does not indicate how long any individual remained progression-free.

The endpoint is useful for comparing the timing of progression or death across randomized groups. It is distinct from objective response, which counts participants meeting a response definition, and from overall survival, which concerns death. The registry record does not provide the detailed tumor-assessment criteria used to determine objective progression.

7. Results Posted in the Registry

• Sunitinib vs Capecitabine: hazard ratio 1.47 (95% CI 1.16–1.87), reported p = 0.002 (as reported in the registry).

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Time to Tumor Progression (TTP)

• Endpoint type: Time to event: compared as a hazard ratio.
• Test: Hazard ratio as reported by the sponsor (Log Rank); it was not recalculated.
• Result:
  • Sunitinib vs Capecitabine: hazard ratio 1.52 (95% CI 1.19–1.93), reported p < 0.001 (as reported in the registry).
• Interpretation:
  • The 95% confidence interval excludes no difference (a ratio of 1), so the hazard of the event is statistically higher for Sunitinib vs Capecitabine than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Number of Participants With Overall Response (OR)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Capecitabine: 16.4% (40/244) versus 11.3% (27/238) on control; risk difference 5.0 percentage points (95% CI -1.1 to 11.2), risk ratio 1.45 (0.92–2.28); unadjusted two-proportion z-test p = 0.109.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Capecitabine and the control. The interval gives the range of effects that remain compatible with the data.

Duration of Response (DR)

• Endpoint type: Time to event: compared as a hazard ratio.
• Test: Hazard ratio as reported by the sponsor (Log Rank); it was not recalculated.
• Result:
  • Sunitinib vs Capecitabine: hazard ratio 2.79 (95% CI 1.04–7.46), reported p = 0.037 (as reported in the registry).
• Interpretation:
  • The 95% confidence interval excludes no difference (a ratio of 1), so the hazard of the event is statistically higher for Sunitinib vs Capecitabine than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists a set of secondary outcomes that broaden the assessment beyond progression-free survival. They include time to tumor progression, overall response, duration and timing of response, overall survival, and quality-of-life measures. This collection covers different dimensions of disease course and participant experience, but the record contains posted results for only some of the listed secondary outcomes.

The posted time-to-event findings have a direction consistent with the primary comparison, while the response results give a separate view based on whether participants met an overall-response definition. Response duration concerns the subset who responded and therefore does not represent the full randomized population in the same way as the primary intent-to-treat analysis. These differences in endpoint and population mean that secondary outcomes should complement, not replace, the primary result.

Secondary analyses generally carry less confirmatory weight when many outcomes are examined and the analysis plan does not report how multiplicity was handled. Testing many outcomes can increase the chance that at least one result appears noteworthy by chance. Whether the protocol designated particular secondary outcomes as confirmatory, and whether any adjustment was planned, is not reported in the registry record. The posted secondary p-values should therefore be interpreted as evidence within a broader set of analyses, not as independent confirmation of the primary result.

The registry record also lists overall survival and quality-of-life instruments among the secondary outcomes, but it does not provide those results in the posted secondary outcome data described for this analysis. Their inclusion in the outcome list does not establish a finding. A complete evaluation of the secondary evidence would require the corresponding estimates, uncertainty measures, analysis populations, and any multiplicity plan, where applicable.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Time to Tumor Progression (TTP)
• Number of Participants With Overall Response (OR)
• Duration of Response (DR)
• Time to Tumor Response (TTR)
• Overall Survival (OS)
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
• EORTC QLQ Breast Cancer Module (BR23)

9. Statistical Interpretation

10. Statistical Methods Explained

What does the median represent?

For a time-to-event outcome, the median is an estimate of the time by which half of the group has experienced the event, as estimated from the observed follow-up. Here, the event is the first documented objective tumor progression or death from any cause. The reported medians are 2.8 months for sunitinib and 4.2 months for capecitabine. A median is a central summary of the event-time distribution; it does not mean that all participants had an event at that time, and it does not summarize the entire shape of the follow-up curve.

Time-to-event methods are useful when participants have differing follow-up lengths or when some have not experienced the event by the end of their observed follow-up. In general, these methods can use the timing of events and account for incomplete event observation through censoring. The registry record does not provide the detailed censoring rules, the number censored, or the handling of missing assessments, so those aspects cannot be evaluated from the posted record.

What does the hazard ratio compare?

The registry reports a hazard ratio of 1.470 for sunitinib versus capecitabine, with a 95% confidence interval from 1.156 to 1.869. A hazard is the instantaneous event rate among participants who have not yet experienced the event, considered over follow-up. A hazard ratio compares those rates between groups. It is not a ratio of median survival times, a difference in months, or the probability that a participant will experience the event.

In this trial, the hazard ratio is reported with the group order sunitinib versus capecitabine. Its value greater than 1 is consistent with the shorter reported median in the sunitinib group. Interpreting a single hazard ratio as a constant relative rate over follow-up relies on assumptions about how the relative hazards behave over time. The registry record does not report a proportional-hazards assessment, and the value should not be read as proof that the relative event rate was constant at every time point.

What is the log-rank analysis?

The log-rank test is a general method for comparing time-to-event outcomes between groups. It compares observed and expected event patterns over follow-up rather than comparing only the medians. The registry identifies the log-rank method for the primary hazard ratio analysis and reports p = 0.002. A p-value describes how compatible the observed data are with a null comparison under the test’s assumptions; it is not the probability that the null is true and does not measure clinical importance.

The reported result comes from the sponsor’s analysis. It should be distinguished from simple recalculations made from posted summary statistics. Recalculated comparisons may use fewer details than the original analysis, such as participant-level event times, stratification factors, or adjustments. The registry record does not report whether such features were used for the primary analysis, so they should not be assumed.

How should response outcomes be distinguished?

Overall response is a binary outcome: participants are counted according to whether they met the response definition. The record reports 27 participants with a response among 238 in the sunitinib group and 40 among 244 in the capecitabine group. It also reports arm-specific response-rate estimates and confidence intervals. A simple unadjusted recalculation of the difference is distinct from a sponsor-reported comparative test. The registry does not report a p-value for a sponsor’s between-group response comparison.

Binary outcomes do not use event timing in the same way as progression-free survival. Response duration, by contrast, is listed as a time-to-event outcome among participants with response. The analyzed groups for that measure are 27 and 40 participants, rather than all randomized participants. This difference in the population contributing to a secondary outcome is important when relating it to the primary intent-to-treat comparison.

Why do confidence intervals matter?

A confidence interval gives a range of estimates compatible with the data and the method used, under repeated-sampling interpretation. In general, a narrower interval indicates greater precision, while a wider interval indicates more uncertainty about the estimated quantity. For the primary hazard ratio, the interval is 1.156 to 1.869. It describes uncertainty in the relative-hazard estimate, not the range of outcomes that individual participants experienced.

Confidence intervals and p-values answer related but different questions. The interval communicates a range of plausible effect estimates under the analysis, while the p-value assesses compatibility with a specified null value. Neither statistic removes the need to consider the trial population, outcome definition, analysis plan, and limitations of the registry record.

11. Confidence Intervals and Precision

The primary hazard ratio is reported as 1.470, with a 95% confidence interval from 1.156 to 1.869. The interval excludes 1, the value corresponding to equal hazards in the usual hazard-ratio interpretation. Its lower and upper limits still leave a range of possible relative-hazard estimates, so the point estimate should not be mistaken for a perfectly precise quantity. The associated reported p-value is 0.002.

The arm-specific median estimates are 2.8 months for sunitinib, with a 95% confidence interval from 2.4 to 4.0 months, and 4.2 months for capecitabine, with a 95% confidence interval from 3.8 to 5.5 months. These intervals express uncertainty around each median. They are not a direct confidence interval for the difference between medians, and comparing overlap between two separate intervals is not a substitute for the reported between-group analysis.

In general, a confidence interval is a range generated by a statistical procedure that would cover the underlying parameter at its stated rate over repeated applications when the model assumptions hold. It does not mean that there is a 95% probability the fixed parameter lies in this particular interval. Precision depends on factors such as the amount and distribution of event information and the analysis method. The registry record does not report the full event counts or details needed to assess those factors independently.

The primary interval is more informative than the point estimate alone, but it cannot address every source of uncertainty. It does not capture uncertainty from unreported protocol decisions, possible measurement issues, or missing-data handling. The registry record also does not report whether the relative-hazard assumption was checked. Statistical precision and broader reliability are related but distinct considerations.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size display is a planning illustration based on the observed effect, not a report of the original trial design calculation. For time-to-event outcomes such as the primary progression-free survival endpoint, the figures are total events across both groups. For other outcomes, the figures are participants per arm. In the primary time-to-event planning illustration, the total-event targets are 212 for 80% power and 284 for 90% power when planning for 100% of the observed effect; the accompanying rows consider smaller fractions of that effect.

The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. For time-to-event outcomes, the calculation uses the Schoenfeld approach and reports total events. For the other outcomes, it reports participants per arm. The trial’s original sample-size assumptions and justification are not reported in the registry record.

In plain language, the 80% power column describes a planning target under which a study designed with the stated assumptions would have an 80% chance of detecting the specified effect at the stated significance level, if that effect and the assumptions were correct. The 90% power column uses a higher target chance of detection under the same general framework. Neither column is a guarantee that a future study will achieve that chance in practice.

The rows for smaller effects require more information: smaller effects need more participants or, for time-to-event outcomes, more total events to distinguish them from random variation with the stated power target. These figures are planning illustrations, not observed power. They should not be read as evidence that the completed trial had a particular probability of finding its result.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

d is the total number of events needed (Schoenfeld's formula) with 1:1 allocation and proportional hazards.

Worked calculation for this trial

1. Hazard ratio HR = 1.470, so ln(HR) = 0.3853.
2. d = 4 × (1.96 + 0.842)² / [ln(1.470)]² = 211.5, rounded up to 212 events in total for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
hr <- 1.47                              # observed hazard ratio
events_needed <- function(power, frac = 1) ceiling(round(4 * (z_a + qnorm(power))^2 / log(hr^frac)^2, 6))   # Schoenfeld, 1:1 allocation
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: events = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(events_needed(0.80, f), big.mark = ","), format(events_needed(0.90, f), big.mark = ",")))

# Simulation: given d total events under proportional hazards, events in the treatment arm are Binomial(d, hr / (1 + hr)).
# The score (log-rank type) statistic is (D1 - d / 2) / sqrt(d / 4).
set.seed(373113)
d    <- events_needed(0.80)
reps <- 20000
D1 <- rbinom(reps, d, hr / (1 + hr))
z  <- (D1 - d / 2) / sqrt(d / 4)
cat(sprintf("Simulated power with %s events: %.3f (%d replicates)\n", format(d, big.mark = ","), mean(abs(z) > z_a), reps))

Output from running the code

100% of observed effect: events = 212 (80% power), 284 (90% power)
 75% of observed effect: events = 377 (80% power), 504 (90% power)
 50% of observed effect: events = 847 (80% power), 1,133 (90% power)
Simulated power with 212 events: 0.785 (20000 replicates)

The simulation uses the fact that, with d events in total and proportional hazards, the number of events in the treatment arm is binomial. It is an approximation that conditions on the total number of events, and it should land close to the target power.

14. Analyses Reported by the Sponsor

The primary hazard ratio and its confidence interval are reported by the registry as the sponsor’s log-rank analysis: 1.470, with a 95% confidence interval from 1.156 to 1.869 and p = 0.002. The primary results presented in the registry match those reported-analysis values. The trial-level interpretation should therefore be anchored in the sponsor’s posted analysis, rather than treating a summary-statistic recalculation as a replacement for it.

For overall response, the sponsor reports an estimate and 95% confidence interval for each group: 11.3% for sunitinib and 16.4% for capecitabine. The registry does not report a sponsor comparative p-value for response. A simple unadjusted recalculation from the posted group counts gives p = 0.109, but that is a separate calculation and not the sponsor’s reported test. It does not account for any unreported adjustment or analysis detail.

Recalculations from summary statistics are useful as checks or illustrations, but they cannot reproduce analyses that may rely on individual event times, stratification, or other details not contained in the registry record. Such details are not reported in the registry record. The sponsor’s own posted analysis is consequently the appropriate source for the reported primary hazard ratio and test result; recalculated quantities should be clearly distinguished and interpreted more narrowly.

15. Multiplicity, Missing Data and Analysis Populations

The registry record identifies progression-free survival as the primary outcome and specifies an intent-to-treat population comprising all randomized participants. That provides important context for the primary analysis. It does not, however, report a complete statistical analysis plan. In particular, the handling of multiplicity across secondary outcomes is not reported in the registry record.

Multiplicity arises when investigators examine multiple outcomes, comparisons, or time points. In general, the more tests conducted, the greater the chance that one may produce a small p-value even when there is no underlying effect for that particular comparison. Statistical procedures can control this issue, but the record does not say whether any such procedure was used for the secondary analyses. The listed p-values should not be treated as if they were all adjusted, and no adjustment should be inferred.

Missing-data procedures and censoring rules are also not reported in the registry record. For a time-to-event endpoint, participants may have follow-up that ends before an event is observed; the handling of that follow-up is part of the analysis specification. For response and quality-of-life measures, the approach to missing assessments can affect which observations contribute. The record does not provide enough detail to evaluate these choices or to determine whether sensitivity analyses were performed.

The primary population is stated as all randomized participants, but the record does not provide a detailed accounting of exclusions, protocol deviations, or the number contributing to every analysis. Some secondary outcomes necessarily concern a narrower group, such as participants with a response for response duration. The record does not describe whether additional analysis populations were defined or how they were used.

Interim analyses, stopping boundaries, and the original sample-size justification are not reported in the registry record. The fact that the status is terminated does not establish why the trial ended or whether a formal stopping decision was made. These are limits on what can be concluded from the registry entry, rather than evidence that any particular method was or was not used.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: disease progression (5.9%), diarrhoea (2.9%), pneumonia (2.1%), thrombocytopenia (2.1%), dyspnoea (2.1%).

The registry reports serious adverse events for 72 of 238 participants at risk in the sunitinib group and 44 of 240 participants at risk in the capecitabine group. Other adverse events are reported for 228 of 238 participants and 229 of 240 participants, respectively. These are counts of participants recorded as affected, with the stated at-risk group sizes; they should not be confused with event totals or with the primary efficacy population counts without considering the denominator stated for each safety measure.

The most frequently listed serious adverse-event terms include disease progression at 5.9%, diarrhoea at 2.9%, and pneumonia, thrombocytopenia, dyspnoea, and pleural effusion at 2.1% each. These are the posted terms and percentages, not a complete description of all safety outcomes. The record does not report deaths in the safety fields, and the number of deaths is not reported in the registry record.

These figures describe events recorded during the trial; they do not establish that a study drug caused an event. The registry entry does not provide details such as event severity beyond the serious-event classification, duration, timing, attribution, or exposure-adjusted rates. Comparisons between groups should be read with those limits in mind, and the counts alone do not characterize an individual participant’s risk.

17. What the Result Does, and Does Not, Mean

The posted primary analysis indicates a difference in progression-free survival between the randomized groups in this trial. The sunitinib group had a reported median of 2.8 months, compared with 4.2 months for capecitabine. The sponsor-reported hazard ratio for sunitinib versus capecitabine was 1.470, with a 95% confidence interval from 1.156 to 1.869 and p = 0.002. These results describe the observed comparison among the randomized participants analyzed for the primary endpoint.

The result does not establish what would happen for every person with advanced breast cancer. The enrolled population was defined by prior taxane and anthracycline treatment history, or by taxane failure when further anthracycline therapy was not indicated. The results also concern the specific regimens recorded in the trial. Generalizing beyond that population or those regimens requires evidence not contained in this registry record.

The result does not show that every participant experienced the group median, nor does it predict an individual participant’s time to progression or death. A hazard ratio is a group-level time-to-event summary, not an individual probability or a direct measure of months gained or lost. The confidence interval communicates statistical uncertainty in the estimate but does not account for all possible limitations of the study record.

The primary endpoint combines objective tumor progression and death from any cause. It is not interchangeable with overall survival, response rate, response duration, or quality of life. Those outcomes answer different questions. The registry lists several of them, but the posted results described for some secondary outcomes do not establish findings for every listed outcome.

Finally, statistical evidence does not by itself determine clinical importance. The registry record does not provide enough information to evaluate all aspects of outcome assessment, missing-data handling, multiplicity, or the reason the study was terminated. Those limits should accompany any interpretation of the reported estimates. The results are evidence about this trial’s randomized comparison, not medical advice or a guarantee of an outcome.

18. Why This Trial Matters Statistically

This trial is statistically informative because it combines a randomized comparison with a time-to-event primary endpoint. Randomization creates a framework for comparing outcome experience across treatment groups, while progression-free survival incorporates both progression and death as defined events. The reported hazard ratio and group medians offer complementary summaries: one compares relative event rates over follow-up, and the others describe the central timing of events.

The example also illustrates why estimates should be read alongside their uncertainty. The hazard ratio is not just a single number: its 95% confidence interval indicates a range of estimates compatible with the analysis. The p-value addresses a different question, concerning the compatibility of the data with a null comparison. Neither is a substitute for examining the endpoint definition, analysis population, and potential limitations.

Secondary outcomes show why trial interpretation is not reducible to one statistic. Response, response duration, tumor progression, survival, and quality of life have different definitions and may involve different populations or analysis methods. Without a reported multiplicity plan, secondary tests need careful contextual interpretation. A collection of outcomes can provide useful context without carrying the same evidential weight as the primary endpoint.

The record also demonstrates a practical distinction between sponsor-reported analyses and unadjusted recalculations from summary data. A simple recalculation can make assumptions and contrasts easier to understand, but it may not reproduce the original analysis. The registry’s primary reported hazard ratio should remain distinct from any recalculated secondary comparison.

Finally, an enrollment total and observed effect do not reveal the original design rationale. Planning illustrations can show how required information changes with target power and effect size, but they are not the trial’s original sample-size justification or a measure of observed power. Keeping those distinctions clear is central to sound interpretation of clinical trial statistics.

19. 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 reports that the study was terminated, but the reason is not reported in the registry record. Termination status alone does not explain whether recruitment, follow-up, an efficacy decision, a safety concern, or another circumstance affected the study. The record also does not report an interim-analysis plan or stopping boundaries.

The study is listed as unmasked. The registry record does not explain whether or how knowledge of treatment assignment might have affected assessment, follow-up, or reporting. This is particularly relevant to outcomes involving assessment schedules or participant-reported quality of life, although the record does not provide enough detail to assess any effect.

The primary endpoint depends on documenting objective tumor progression or death. The detailed tumor-assessment criteria, independent review procedures, and censoring rules are not reported in the registry record. The record gives a planned assessment timeframe, but that alone does not reveal how assessments that were delayed, missed, or unavailable were handled.

Analysis details are limited. The intent-to-treat primary population is identified, but the full statistical analysis plan, handling of missing data, proportional-hazards assessment, and multiplicity approach are not reported in the registry record. The reason for the difference between the safety denominators and primary endpoint denominators is also not described in detail. Secondary outcomes may use distinct analysis populations, and response duration is based on participants who responded.

The registry lists secondary outcomes for overall survival and quality of life, but their results are not included in the posted secondary measures described in this record. As a result, the breadth of outcomes listed should not be mistaken for a full set of available findings. These limitations constrain interpretation of the record; they do not establish that any particular unreported procedure was absent from the original study.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine — NCT00373113.
• Registry record last updated 2012-06-25; status last verified 2012-06.
• Results first posted 2010-11-18.
• 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.

23. Record Summary

NCT00373113 is recorded as a randomized, open-label, parallel-group Phase III trial comparing sunitinib malate with capecitabine in advanced breast cancer after specified prior chemotherapy. The registry lists 482 participants enrolled and identifies progression-free survival as the primary endpoint in an intent-to-treat population of all randomized participants.

The reported median progression-free survival was 2.8 months for sunitinib and 4.2 months for capecitabine. The sponsor-reported log-rank hazard ratio for sunitinib versus capecitabine was 1.470, with a 95% confidence interval from 1.156 to 1.869 and p = 0.002. The record also includes selected secondary efficacy and safety results, but does not report several details needed to assess the full statistical plan or missing-data procedures.

The study status is terminated. The reason for termination is not reported in the registry record. The results should be interpreted for the trial population, regimens, endpoint definitions, and analysis details recorded, with the limitations of the registry record in view.