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 Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. (NCT00099437), a randomized phase 3 study. The primary outcome is Time to Progression (TTP).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00099437 |
| Phase | Phase 3 |
| Condition | Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 736 |
| Arms in the primary outcome | 2 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women with oestrogen receptor positive advanced breast cancer whose disease was progressing or had relapsed after previous endocrine therapy. The primary endpoint’s population field is blank in the registry record, so additional eligibility or analysis-population details are not reported in the registry record.
Intervention
Fulvestrant 500 mg. The registry describes the intervention as a drug and identifies this dose as one of the two parallel study arms.
Comparator
Fulvestrant 250 mg, identified in the registry as the standard dose in the study summary.
Primary question
How did the recorded time to progression compare between the two fulvestrant dose groups? The endpoint is defined as the time from randomisation until objective disease progression or death in the absence of objective progression. The registry reports a median for each arm, but a sponsor-reported hazard ratio or other comparative primary analysis is not reported in the registry record.
The study also recorded response, clinical benefit, overall survival and a quality-of-life-related measure, among other secondary outcomes. Those outcomes provide different kinds of information: some describe tumour response or clinical benefit, while others concern survival or patient-reported scores. They do not replace the primary endpoint, and their interpretation depends on their own definitions, analysis populations and follow-up.
The question is about a comparison between assigned doses in the enrolled trial population, not about whether either dose is effective compared with no treatment or another drug. Both arms received fulvestrant. The posted results therefore do not provide a no-fulvestrant comparison, and the registry record does not give enough information to extend the finding to patients outside the stated study population.
3. Trial Design
This was a phase III, randomized, double-blind, parallel-group, multicentre study. The registry records quadruple masking, meaning the record classifies the study as masked at four roles or levels; it does not identify those roles or describe how masking was implemented. Random allocation is recorded, but the sequence-generation method, allocation concealment procedures and details of the sites are not reported in the registry record.
The comparison was between fulvestrant 500 mg and fulvestrant 250 mg. The registry reports an enrollment of 736. For the primary time-to-progression outcome, the posted arm counts are 374 for fulvestrant 250 mg and 362 for fulvestrant 500 mg. These are the recorded endpoint counts; the record does not state whether they correspond to all randomized participants or a separately defined analysis population.
The study start date is 2005-02-13, and the primary completion date is 2009-02-27. The overall record status is active, not recruiting. These fields describe the registry record and do not, by themselves, establish the status of every follow-up activity or the completeness of all outcome reporting.
Time to progression was assessed using RECIST tumour assessments scheduled every 12 weeks, with a tolerance of plus or minus 2 weeks, from randomisation for a study duration of 48 months. The primary endpoint description includes death when it occurred without objective progression. The registry does not report the censoring rules, adjudication procedures, data-cutoff details or statistical analysis plan for this endpoint.
Secondary outcome descriptions include RECIST-based objective response and clinical benefit, overall survival, duration measures, and change in the Trial Outcome Index. The questionnaire schedule for the Trial Outcome Index was every 4 weeks from randomisation until week 24 and again at treatment discontinuation. Additional design details, including the planned sample-size justification, interim analyses and prespecified analysis populations, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| STARTED | 374 | 362 |
| COMPLETED | 8 | 13 |
| NOT COMPLETED | 366 | 349 |
Reasons for not completing this period:
| Reason | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Lost to Follow-up | 30 | 33 |
| Death | 293 | 261 |
| Withdrawal by Subject | 6 | 10 |
| Ongoing in FU but not on treatment | 37 | 45 |
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 | Fulvestrant 250 mg | Fulvestrant 500 mg | Total |
|---|---|---|---|---|
| Participants analysed | 374 | 362 | 736 | |
| Age, Continuous | Years | 60.8 (SD 11.94) | 61.0 (SD 11.47) | 60.9 (SD 11.71) |
| Sex: Female, Male: Female | Participants | 374 | 362 | 736 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Progression (TTP), measured over RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint, time to progression, measures the interval from randomisation until objective disease progression or death when objective progression has not occurred. Tumour progression was assessed using RECIST, with assessments scheduled every 12 weeks, plus or minus 2 weeks, for a study duration of 48 months. This endpoint combines information about when progression is observed with the timing of death in the absence of documented progression, as stated in the registry definition.
Time-to-event endpoints are used when the outcome of interest is the time until a specified event, rather than only whether the event occurred by a single fixed date. In general, this approach can retain information about event timing and can accommodate participants whose event has not been observed by the end of available follow-up, provided the analysis handles censoring appropriately. The registry record does not describe the censoring rules or the sponsor’s analysis method for this endpoint.
The posted median time to progression is 5.5 months for fulvestrant 250 mg and 6.5 months for fulvestrant 500 mg. A median describes the point in the observed time distribution at which half the observations are on either side, subject to the endpoint’s analysis methods. The registry gives no upper range value for either arm and no comparative confidence interval or sponsor-reported hazard ratio. The arm medians alone do not describe the full time-to-event distributions or establish the size or precision of a treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median time to progression of 5.5 months in the fulvestrant 250 mg group and 6.5 months in the fulvestrant 500 mg group. These are descriptive arm-level summaries. They do not, on their own, show how uncertain the difference between groups is, whether the time-to-event distributions differed across follow-up, or how a sponsor analysis assessed the comparison.
A comparative primary analysis is not reported in the registry record. In particular, no sponsor-reported hazard ratio, confidence interval or p-value for time to progression is posted. The registry record also identifies that values were missing or not estimable for a two-arm comparison of the median-time endpoint. As a result, the median values should not be turned into a newly calculated treatment contrast or treated as a substitute for a time-to-event analysis.
The secondary outcomes include recalculated unadjusted comparisons for objective response rate, clinical benefit rate and change in Trial Outcome Index. Their confidence intervals include values on both sides of the no-difference point. The unadjusted p-values posted for those recalculations are 0.795, 0.099 and 0.579, respectively. These are simple, unadjusted re-calculations from the posted summary statistics, not sponsor-reported analyses; the registry lists no reported analyses for these secondary endpoints. They should be read as exploratory descriptions rather than as a replacement for the primary comparison.
The endpoint counts differ across outcomes. For example, the objective response figures use fewer participants than the primary endpoint counts, and the Trial Outcome Index figures use much smaller endpoint groups. The registry does not explain these differences or report missing-data handling, so the reasons for the varying denominators cannot be determined from the record. The difference in endpoint counts also means that results across measures do not necessarily represent identical participant sets.
In general, a confidence interval expresses a range of values compatible with the data and the assumptions of the analysis; it is not a guarantee that the true effect lies within the interval. The recalculated secondary confidence intervals are broad enough to include no difference as well as effects in either direction. That uncertainty, the lack of reported sponsor analyses and the absence of a documented multiplicity strategy all limit the strength of conclusions from the secondary findings.
No conclusion about the comparative effect on overall survival can be drawn from the listed secondary outcome names alone. Although overall survival and follow-up are named, numerical results for them are not included in the posted outcomes described in the registry record. Likewise, the serious adverse event counts describe reported events in the two groups but are not a substitute for a complete safety analysis or a causal comparison.
Overall, the registry record offers arm-level primary medians and selected secondary summaries, but not the primary comparative analysis needed to quantify the time-to-progression contrast precisely. The correct statistical reading is therefore descriptive and cautious: the reported medians differ, but the comparative magnitude and uncertainty of the primary endpoint are not reported in the registry record.
9. Statistical Methods Explained
Time to progression is a time-to-event outcome. Its value for each participant concerns the time from randomisation to the event specified by the endpoint definition: objective progression, or death in the absence of objective progression. A time-to-event analysis generally uses both event times and information about participants whose event is not observed during their available follow-up. Such participants may be censored, but valid interpretation depends on prespecified rules for defining and handling censoring. Those rules are not reported in the registry record.
What does the median describe?
The median time is a summary of the distribution of event times. It is not the average time to progression, and it does not convey the shape of the full distribution. Two groups can have different medians while their event-time distributions overlap substantially; conversely, a single median cannot show whether group differences change over follow-up. The posted primary medians are 5.5 months for fulvestrant 250 mg and 6.5 months for fulvestrant 500 mg. The registry does not report confidence intervals for those medians or a sponsor-reported comparative hazard ratio.
In general, a hazard ratio compares the event rates between groups over time under a time-to-event model. It is not the same as a ratio of medians, and it relies on assumptions that should be assessed in the analysis. No sponsor-reported hazard ratio for the primary endpoint is present in the registry record. Since the record identifies the median-time comparison as missing or not estimable, a new two-arm calculation is not appropriate from the posted medians alone.
How should the secondary comparisons be read?
The posted secondary re-calculations use unadjusted summary-statistic comparisons. For binary outcomes such as objective response and clinical benefit, a risk difference expresses the difference between the two groups’ observed event proportions on the analysis scale. Its confidence interval represents uncertainty under the calculation’s assumptions. A confidence interval spanning the no-difference value indicates that the posted summary statistics do not pin down the direction of the contrast precisely. These re-calculations are not sponsor analyses; the registry lists no reported analyses for these outcomes.
For the Trial Outcome Index, the posted re-calculation compares the group means. The mean difference is reported as -1.6, with a confidence interval from -7.257 to 4.057. The registry reports group means and standard deviations, but the endpoint counts are 35 and 34. The record does not explain why these counts are smaller than the primary endpoint counts, what missing-data approach was used, or how repeated questionnaire measurements over time were incorporated into the posted endpoint summary. The reported summary therefore should not be assumed to represent a model of all measurements across the study.
Confidence intervals are useful because they show a range of estimates compatible with the data under the analysis assumptions. They describe statistical uncertainty, not all sources of uncertainty. For example, they do not resolve concerns about missing data, outcome selection, measurement, bias or model assumptions. They also do not imply that all values inside the interval are equally plausible.
Why does multiplicity matter?
When many outcomes are examined, there are more opportunities for an apparently notable result to arise by chance. A multiplicity strategy may adjust how results are tested or interpreted, for example by allocating the overall error rate across a family of outcomes. No multiplicity adjustment or prespecified hierarchy for the secondary outcomes is reported in the registry record. The posted secondary p-values are explicitly unadjusted re-calculations, so they should not be treated as confirmatory evidence. The protocol’s planned approach to multiplicity is not reported in the registry record.
What do the planning illustrations mean?
The sample-size illustrations use the observed effect as a planning reference, with scenarios based on detecting 100%, 75% or 50% of that observed effect. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between arms and a normal approximation. For the time-to-event method, the stated approach uses a total event count; the other illustrations express participants per arm. These are planning illustrations, not observed power and not evidence about the design assumptions used for this trial. The trial’s own sample-size justification is not reported in the registry record.
In general, a planning calculation estimates how much information might be needed to detect a specified effect under stated assumptions. Using an effect observed in the same trial as the planning target is illustrative and can produce unstable estimates, particularly when that observed effect is small or uncertain. Such a calculation should not be read as proof that the trial was adequately powered, nor as a retrospective probability that the trial detected a true effect.
What remains unknown from the statistical record?
The registry record does not report the detailed statistical analysis plan, the primary analysis population, the censoring rules, the method used for the primary endpoint, interim analyses or the sample-size justification. It does not report the handling of missing outcome data or the reasons endpoint denominators differ. These omissions matter because they prevent a reader from checking whether the posted summaries follow prespecified procedures and how sensitive the results may be to the analysis choices.
10. Multiplicity, Missing Data and Analysis Populations
Several details needed to evaluate the inferential framework are not reported in the registry record. No prespecified multiplicity strategy is described for the collection of secondary outcomes. Without that information, the unadjusted secondary p-values cannot be interpreted as if they were protected from the increased chance of false-positive findings that can arise when multiple outcomes are assessed. The record does not state whether any outcomes were prioritized or whether formal testing stopped after a particular result.
The registry lists no reported analyses for the posted secondary outcomes. The comparisons available alongside some outcome summaries are unadjusted re-calculations from posted summary statistics. They do not reveal what models, covariate adjustments or testing procedures the sponsor may have used. No sponsor-reported comparative analysis for the primary time-to-progression endpoint is listed.
Missing-data methods are also not reported. The recorded denominators vary between outcomes, including the smaller groups used for the Trial Outcome Index. The registry does not explain whether differences reflect missing measurements, eligibility for an outcome, analysis-population definitions or another reason. It does not report the extent or pattern of missingness, imputation methods, sensitivity analyses or assumptions about participants with incomplete follow-up.
The primary endpoint population field is blank, and analysis-population definitions are not reported in the registry record. Although randomisation and enrollment are documented, the record does not say whether each outcome was analyzed in an intention-to-treat population, a per-protocol population or another defined group. The available endpoint counts should therefore be read as outcome-specific counts, not as a complete account of the analysis populations.
These gaps do not show that an inappropriate method was used; they mean the registry record does not provide enough information to assess the method. For the primary endpoint, censoring rules and the statistical model are not reported. For the secondary outcomes, missing-data handling and multiplicity procedures are not reported. Those details are important when judging how precise, robust and confirmatory the posted results are.
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 |
|---|---|---|---|
| Fulvestrant 250 mg | 27 | 374 | 7.2% |
| Fulvestrant 500 mg | 35 | 361 | 9.7% |
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 |
|---|---|
| Fulvestrant 250 mg | 235 of 374 |
| Fulvestrant 500 mg | 241 of 361 |
Most frequent serious adverse event terms
| Event term | Organ system | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 1 of 374 | 3 of 361 |
| Vomiting | Gastrointestinal disorders | 1 of 374 | 3 of 361 |
| Femur Fracture | Injury, poisoning and procedural complications | 2 of 374 | 1 of 361 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 374 | 2 of 361 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1 of 374 | 1 of 361 |
| Acute Myocardial Infarction | Cardiac disorders | 2 of 374 | 0 of 361 |
| Constipation | Gastrointestinal disorders | 1 of 374 | 1 of 361 |
| Bronchitis | Infections and infestations | 0 of 374 | 2 of 361 |
| Bronchopneumonia | Infections and infestations | 1 of 374 | 1 of 361 |
| Pneumonia | Infections and infestations | 0 of 374 | 2 of 361 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 51 of 374 | 35 of 361 |
| Injection Site Pain | Gastrointestinal disorders | 34 of 374 | 42 of 361 |
| Back Pain | Musculoskeletal and connective tissue disorders | 40 of 374 | 26 of 361 |
| Bone Pain | Musculoskeletal and connective tissue disorders | 28 of 374 | 34 of 361 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 29 of 374 | 29 of 361 |
| Headache | Nervous system disorders | 25 of 374 | 28 of 361 |
| Fatigue | Gastrointestinal disorders | 24 of 374 | 27 of 361 |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | 26 of 374 | 25 of 361 |
| Hot Flush | Vascular disorders | 22 of 374 | 24 of 361 |
| Asthenia | Gastrointestinal disorders | 23 of 374 | 21 of 361 |
Serious events with the highest arm-level rate: anaemia (0.8%), vomiting (0.8%), bronchitis (0.6%), pneumonia (0.6%), hyperglycaemia (0.6%).
The registry reports serious adverse events in 27 of 374 participants in the fulvestrant 250 mg group and 35 of 361 in the fulvestrant 500 mg group. It also reports other adverse events in 235 of 374 and 241 of 361 participants, respectively. These are counts of participants recorded as affected in each group. The registry does not provide a comparative safety analysis, confidence intervals or a description of how event attribution and coding were handled.
The listed serious adverse event terms include anaemia and vomiting, each at 0.8%, and bronchitis, pneumonia, hyperglycaemia and dyspnoea, each at 0.6%. These term-specific figures describe what is listed in the registry record; they do not establish that an event was caused by treatment. The record does not report deaths in the safety summary, and the death values are not available.
In general, safety counts should be interpreted with attention to the event definitions, observation period, exposure time and whether participants could experience more than one event. Those details are not reported in the registry record. The counts therefore provide a limited descriptive view, not a complete assessment of comparative safety or a basis for treatment advice.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of two fulvestrant doses in postmenopausal women with oestrogen receptor positive advanced breast cancer after previous endocrine therapy. It reports median time to progression of 5.5 months for the 250 mg group and 6.5 months for the 500 mg group. These figures summarize the recorded endpoint by arm; without a sponsor-reported comparative analysis, they do not establish the precision or statistical significance of the contrast.
The available secondary summaries provide additional descriptive information, but their re-calculated comparisons are unadjusted and are not sponsor-reported analyses. The registry does not report a multiplicity plan, the handling of missing data or the analysis populations. These omissions limit the extent to which the secondary results can be interpreted as confirmatory or generalized across outcomes.
The result does not show how the two doses compare with no treatment, another therapy or a different population. It does not establish the full time-to-progression distribution, the comparative effect on overall survival, or the cause of reported adverse events. The registry names several additional outcomes but does not include numerical results for all of them in the posted result details.
In general, an arm-level median is not a complete treatment-effect estimate. A comparative time-to-event analysis, its uncertainty interval and the analysis assumptions would be needed to assess the relative timing of events more fully. Those primary comparative details are not reported in the registry record. The reported information should therefore be understood as a limited account of trial outcomes rather than a complete statistical evaluation.
No medical conclusion or treatment recommendation follows from these registry summaries alone. Interpretation is bounded by the study population, the recorded outcome definitions, the available endpoint counts and the analysis detail reported in the registry.
13. Why This Trial Matters Statistically
Statistically, this trial illustrates why the endpoint summary and the treatment comparison are not the same thing. The registry reports a median for each arm, but the primary question is comparative: how the event-time experience differed between randomized groups, with what uncertainty and under what analysis assumptions. Without a sponsor-reported hazard ratio or other comparative primary analysis, arm medians alone leave that question incompletely answered.
The record also shows why endpoint-specific denominators matter. The primary outcome and secondary outcomes do not all use the same counts. In particular, the Trial Outcome Index summaries are based on much smaller groups than the primary endpoint. Without documented analysis populations and missing-data handling, it is not possible to determine why those counts differ or how representative each summary is of the randomized population.
Multiplicity is another important issue. A trial can report many secondary outcomes, but unadjusted tests do not automatically provide confirmatory evidence across that set. The registry does not describe a testing hierarchy or adjustment, and the listed secondary comparisons are recalculated from summary statistics rather than reported sponsor analyses. Readers therefore need to distinguish descriptive patterns from prespecified confirmatory tests.
Finally, planning calculations should not be confused with evidence about the trial’s design or its observed success. The posted illustrations use stated assumptions and observed effects as planning references; they are not observed power. The registry’s own sample-size justification is not reported. Taken together, these features make the record useful for understanding the trial’s basic comparison and outcome reporting while also highlighting how statistical interpretation depends on complete analysis documentation.
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 primary endpoint is reported as arm-level medians, without a sponsor-reported hazard ratio, confidence interval or p-value. The registry indicates that a two-arm comparison for the median-time endpoint was missing or not estimable. This is the central limitation for interpreting the primary research question: the record does not quantify the comparative time-to-progression effect or its precision.
Important time-to-event analysis details are not reported, including censoring rules, the statistical model and the primary analysis population. The scheduled RECIST assessment interval is described, but the record does not provide details about assessment review, handling of deaths, or how timing between assessments was represented analytically. The median values also do not summarize the entire event-time distribution.
Outcome counts vary. The record does not explain the reasons, report missingness patterns or describe methods for incomplete outcome data. This is especially relevant to the Trial Outcome Index summaries, which use 35 and 34 participants. Without knowing why these endpoint counts differ from other outcomes, it is not possible to assess the implications for selection or representativeness.
The secondary comparative statistics are unadjusted re-calculations from summary data, and the registry lists no sponsor-reported analyses for them. No multiplicity strategy is reported, so those comparisons should not be treated as confirmatory. Numerical results for some named secondary outcomes, including overall survival, are not included in the posted result details.
The safety information is also limited to reported counts and selected serious-event terms. Comparative uncertainty, exposure-adjusted rates, event definitions and attribution details are not reported. These limitations concern the completeness and interpretability of the registry record; they do not establish that the trial’s full reports or analysis documentation lack such information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. — NCT00099437.
- Registry record last updated 2026-09-14; status last verified 2026-09.
- Results first posted 2010-06-15.
- 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
NCT00099437 is a randomized, double-blind, parallel-group, multicentre, phase III study comparing fulvestrant 500 mg with fulvestrant 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previous endocrine therapy. The registry records quadruple masking and enrollment of 736.
The primary endpoint was time to progression, defined from randomisation until objective progression or death without objective progression. Median times are reported as 5.5 months for 250 mg and 6.5 months for 500 mg, but a sponsor-reported comparative analysis is not reported in the registry record. Secondary outcomes include response, clinical benefit, duration measures, overall survival and Trial Outcome Index change. The record lists no reported secondary analyses; selected comparisons are unadjusted re-calculations.
The study start date is 2005-02-13, primary completion date is 2009-02-27, and status is active, not recruiting. Detailed statistical methods, analysis populations, missing-data handling, multiplicity procedures and the trial’s sample-size justification are not reported in the registry record.