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 A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (NCT01094184), a non-randomized phase 4 study. The primary outcome is Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01094184 |
| Phase | Phase 4 |
| Condition | Breast Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 49 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
Female participants with advanced triple-negative breast cancer: estrogen-, progesterone- and HER2-negative disease. The primary endpoint description defines the intent-to-treat population as participants who received at least 1 dose of all study medication, including a taxane and bevacizumab. The registry record does not report the number who completed the FACT-B questionnaire at each assessment.
Intervention
Bevacizumab was given with paclitaxel or docetaxel. One group received bevacizumab 10 mg/kg Q2W; another received 15 mg/kg Q3W. Taxane choice and schedule were at the treating physician’s discretion: paclitaxel Q1W or docetaxel Q3W.
Comparator
The registry record describes two parallel treatment groups, but allocation was non-randomized and there was no stated untreated or usual-care control group. The groups therefore should not be read as a like-for-like randomized comparison. Differences between them could reflect how participants entered or received treatment, as well as treatment itself.
Primary question
The primary endpoint was change from baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) score at Cycle 2. FACT-B is a health-related quality-of-life measure for participants with breast cancer. The clinical question is whether scores changed between baseline and Cycle 2 among participants with the required questionnaire data. The change estimates, group-specific results and uncertainty measures are not reported in the registry record, so the direction and precision of any change cannot be described.
3. Trial Design
This was a Phase 4, open-label, multi-center, parallel study with non-randomized allocation. The registry record lists the study as completed and records an enrollment of 49. Because allocation was not randomized and masking was absent, the design is descriptive rather than a randomized test of one regimen against another. Participants and treating clinicians knew which treatment was given, and clinicians could choose the taxane regimen.
The two listed groups differed in bevacizumab schedule. The 10 mg/kg Q2W group received bevacizumab every 2 weeks, with paclitaxel every week or docetaxel every 3 weeks according to the treating physician’s discretion. The 15 mg/kg Q3W group received bevacizumab every 3 weeks with the same stated taxane choices. The registry description for the first group is cut off after its stopping conditions begin; the full stopping text is not reported in the registry record. For the second group, the description names disease progression, unacceptable toxicity or withdrawal of consent.
The study summary describes assessment of safety, tolerability, disease progression, survival time and Karnofsky performance status. Listed secondary outcomes include death from any cause, overall survival, disease progression, time to progression and Karnofsky performance status scores. The primary endpoint was change in FACT-B score at Cycle 2. The registry record does not report a detailed allocation procedure, a protocol for choosing between taxanes, or a rationale for the group schedules. These details should not be inferred from the treatment descriptions.
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: A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment
Overall Study
| Stage | Bevacizumab 10 mg/kg Q2W | Bevacizumab 15 mg/kg Q3W |
|---|---|---|
| STARTED | 36 | 13 |
| COMPLETED | 1 | 2 |
| NOT COMPLETED | 35 | 11 |
Reasons for not completing this period:
| Reason | Bevacizumab 10 mg/kg Q2W | Bevacizumab 15 mg/kg Q3W |
|---|---|---|
| Death | 35 | 11 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) analysis population included all participants who received at least 1 dose of all study medication (taxane and bevacizumab). 'Overall Number of Participants Analyzed'=participants who completed the questionnaire at Baseline; 'Number Analyzed'=participants who completed the questionnaire at Baseline and at specified time point.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety analysis population included all participants who received at least one dose of study medication (taxane \[paclitaxel/ docetaxel\] or bevacizumab).
| Characteristic | Unit | Bevacizumab 10 mg/kg Q2W | Bevacizumab 15 mg/kg Q3W | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 13 | 49 | |
| Age, Continuous | years | 52.8 (SD 14.74) | 58.4 (SD 9.22) | 54.2 (SD 13.64) |
| Sex: Female, Male: Female | Participants | 36 | 13 | 49 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2, measured over Baseline, Cycle 2 (Cycle length=2 and 3 weeks).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in the FACT-B score at Cycle 2. The registry record describes FACT-B as a 36-item measure of health-related quality of life for participants with breast cancer. Its five subscales cover physical, functional, social/family and emotional well-being, along with a breast cancer subscale. The total possible score ranges from 0 to 144, and a higher score represents better quality of life. Individual items range from 0, “Not at all,” to 4, “Very much.”
Change over time can describe how questionnaire scores differ between a participant’s baseline assessment and a later assessment. A baseline-referenced endpoint can help distinguish the measured follow-up status from the starting score, although interpretation depends on the available paired data and the handling of missing questionnaires. The registry record identifies Cycle 2 as the follow-up point, with cycle lengths of 2 and 3 weeks. It does not report the group-specific mean changes, standard deviations, numbers analyzed or an estimate of uncertainty. Consequently, the magnitude and precision of change cannot be assessed from the reported endpoint information.
As a general measurement point, a scale score is an observed summary of questionnaire responses, not a direct measure of every aspect of a participant’s health. A mean can describe the group’s average score change, while variation among individuals is important context. The registry record identifies the endpoint parameter as a mean and its dispersion as a standard deviation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint is a continuous measure: change in FACT-B score from baseline to Cycle 2. The registry record specifies a mean and standard deviation as the summary measures, but it does not report the actual change estimates, group-specific means, standard deviations, numbers analyzed or confidence intervals. It also does not report a primary endpoint test statistic or p-value. The registry record therefore does not establish whether scores increased, decreased or remained similar, nor how precisely any change was estimated.
The record describes two treatment groups, but it explicitly records non-randomized allocation. A difference in outcomes between these groups, if one were reported, would not by itself identify an effect of the bevacizumab schedule. The groups may differ in participant characteristics, clinical decisions or other factors. The choice between paclitaxel and docetaxel was at the treating physician’s discretion, adding another source of treatment variation. The study is open-label, so participants and clinicians knew treatment assignment; the record does not describe whether or how that could affect questionnaire completion or responses.
The enrollment figure is 49, but that is not a substitute for the number contributing data to the primary endpoint. The endpoint description distinguishes participants who received study medication from those who completed questionnaires. The counts completing questionnaires at baseline and Cycle 2 are not reported in the registry record. Without these counts and a description of missing-data handling, the completeness and representativeness of the endpoint data cannot be judged.
The registry record lists 115 outcome measures and zero analysis records. These registry entries do not provide the missing endpoint estimates or explain how the outcomes were analyzed. No adjustment strategy, model specification or multiplicity plan is reported in the registry record. Accordingly, the primary endpoint should be read as a planned measurement, not as evidence of a particular direction or size of change. Any clinical or comparative conclusion would require outcome estimates and their uncertainty, together with information about who contributed data and how the analyses were conducted.
In general, uncertainty matters as much as an estimate: a confidence interval describes a range of values compatible with the data and analysis assumptions. No interval is reported for the primary endpoint. The posted record supports description of the question and design, but not a quantitative judgment about the endpoint result.
9. Statistical Methods Explained
The primary outcome is a continuous variable, and the registry record identifies the mean as its summary parameter and the standard deviation as its dispersion measure. In general, a mean gives the average observed value or change across the analyzed participants. A standard deviation describes how spread out individual values are around that mean. It is not the same as a confidence interval: the standard deviation describes variation among observations, while a confidence interval expresses uncertainty about an estimated quantity under a specified analysis.
For a change-from-baseline outcome, each analyzed participant needs a baseline score and a Cycle 2 score, or a specified method for handling a missing assessment. In general, a mean change can summarize the average within-participant difference. Interpreting that mean requires knowing how many participants had usable data, how missing questionnaires were treated and whether the analyzed participants represent the study population of interest. The registry record describes participants who completed the questionnaire at baseline and refers to the number analyzed as participants who completed the questionnaire, but the text is truncated and outcome-specific counts are not reported in the registry record.
The FACT-B total score ranges from 0 to 144, with higher scores representing better quality of life. The listed subscales cover different domains, and their ranges differ. General interpretation should therefore distinguish the total score from any subscale score; results on one domain would not automatically describe another. The registry record names the total FACT-B score as the primary endpoint but does not report whether subscale analyses were conducted or how such analyses would be interpreted.
Non-randomized allocation is important to the statistical interpretation. In general, random assignment helps balance both measured and unmeasured characteristics across groups on average. With non-randomized assignment, treatment groups can differ before treatment, and statistical adjustment can address only the factors that were measured and modeled appropriately. The registry record does not report a specific adjustment model, covariates or a causal analysis plan. It also states that taxane selection was at the treating physician’s discretion. Therefore, a simple comparison of group summaries would be descriptive and could not isolate the effect of a bevacizumab schedule from differences in participant selection or accompanying taxane therapy.
Open-label conduct means treatment assignment was not masked. As a general matter, knowledge of treatment can affect reported outcomes, clinical management and decisions about assessment. This is particularly relevant to a patient-reported quality-of-life measure, although the registry record does not document whether such effects occurred. It does not report procedures for questionnaire administration, blinded assessment or other measures intended to reduce potential measurement effects.
The registry record lists a sample-size planning illustration based on an observed effect, a two-sided significance level of 0.05, equal allocation between groups and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s original design or an estimate of the probability that the study detected an effect. The actual planning outputs are not reported in the registry record. The trial’s sample-size justification is also not reported in the registry record. In general, sample-size illustrations depend on their assumptions and should not be read as observed power or as evidence that an outcome was detected.
For continuous outcomes, a normal approximation is a general method that can be used for planning or inference under suitable assumptions. Its adequacy depends on the outcome distribution, sample size and analysis method. The registry record does not report diagnostics or a specific inferential model for FACT-B change. It also does not report whether the endpoint analysis used unadjusted or adjusted estimates, how standard errors were calculated, or whether confidence intervals were produced.
Multiplicity concerns arise when several outcomes or analyses are considered. In general, testing many hypotheses without an appropriate plan can increase the chance of at least one chance-positive finding. The record lists numerous outcomes, but the analysis records count is zero and no multiplicity strategy is reported in the registry record. The number of listed outcomes alone does not reveal how many were formally tested, their hierarchy, or whether any adjustment was used.
Time-to-event outcomes such as overall survival or time to disease progression require methods that account for follow-up duration and censoring. In general, censoring means an event time is not observed during the available follow-up, rather than establishing that an event will never occur. The registry record lists these secondary outcomes but does not report their estimates, event counts, analysis methods or follow-up summaries. No time-to-event result should be inferred from the outcome names alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a broad set of outcomes, including quality of life, death, overall survival, disease progression, time to progression and Karnofsky performance status. It records 115 outcome measures, but zero analysis records. The registry record does not report a hierarchy of endpoints, a multiplicity adjustment, a family of hypotheses or a strategy for interpreting results across outcomes. In general, when multiple outcomes or tests are examined, the interpretation of isolated statistical findings depends on whether their multiplicity was anticipated and addressed. The presence of many outcome measures does not by itself show that formal tests were performed.
The primary endpoint description identifies an intent-to-treat analysis population as participants who received at least 1 dose of all study medication, meaning taxane and bevacizumab. It also distinguishes questionnaire completers from the broader treated population. The number with baseline questionnaires, the number with Cycle 2 questionnaires and the number included in the endpoint analysis are not reported in the registry record.
Missing-data handling is not reported in the registry record. It is therefore unclear whether incomplete questionnaires were excluded, whether any score-completion rules were applied, or whether an imputation or other method was used. In general, missingness can affect estimates if questionnaire completion is related to health status, treatment experience or other factors. Without counts and methods, the direction or size of any such effect cannot be assessed. The record also does not report sensitivity analyses or how participants who discontinued treatment were handled for the quality-of-life endpoint.
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 |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | 15 | 36 | 41.7% |
| Bevacizumab 15 mg/kg Q3W | 7 | 13 | 53.8% |
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 |
|---|---|
| Bevacizumab 10 mg/kg Q2W | 35 of 36 |
| Bevacizumab 15 mg/kg Q3W | 13 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Bevacizumab 10 mg/kg Q2W | Bevacizumab 15 mg/kg Q3W |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 0 of 36 | 2 of 13 |
| Infection | Infections and infestations | 2 of 36 | 0 of 13 |
| Lower respiratory tract infection | Infections and infestations | 1 of 36 | 1 of 13 |
| Overdose | Injury, poisoning and procedural complications | 2 of 36 | 0 of 13 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2 of 36 | 0 of 13 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 36 | 1 of 13 |
| Diarrhoea | Gastrointestinal disorders | 1 of 36 | 0 of 13 |
| Small intestinal perforation | Gastrointestinal disorders | 0 of 36 | 1 of 13 |
| Catheter site dermatitis | General disorders | 0 of 36 | 1 of 13 |
| Disease progression | General disorders | 1 of 36 | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bevacizumab 10 mg/kg Q2W | Bevacizumab 15 mg/kg Q3W |
|---|---|---|---|
| Fatigue | General disorders | 26 of 36 | 9 of 13 |
| Neuropathy peripheral | Nervous system disorders | 17 of 36 | 8 of 13 |
| Constipation | Gastrointestinal disorders | 14 of 36 | 5 of 13 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 14 of 36 | 4 of 13 |
| Nausea | Gastrointestinal disorders | 13 of 36 | 4 of 13 |
| Diarrhoea | Gastrointestinal disorders | 11 of 36 | 5 of 13 |
| Headache | Nervous system disorders | 11 of 36 | 3 of 13 |
| Cough | Respiratory, thoracic and mediastinal disorders | 10 of 36 | 4 of 13 |
| Alopecia | Skin and subcutaneous tissue disorders | 11 of 36 | 3 of 13 |
| Mucosal inflammation | General disorders | 11 of 36 | 2 of 13 |
Serious events with the highest arm-level rate: neutropenia (15.4%), small intestinal perforation (7.7%), catheter site dermatitis (7.7%), gastroenteritis (7.7%), lower respiratory tract infection (7.7%).
The registry record reports serious adverse event figures for the two bevacizumab groups. For bevacizumab 10 mg/kg Q2W, the serious-adverse-event fields list 36 at risk and 15 affected. For bevacizumab 15 mg/kg Q3W, they list 13 at risk and 7 affected. These are group-level registry counts; they do not establish that the groups were comparable, and they should not be interpreted as a randomized comparison.
The record also lists serious adverse event terms and percentages: neutropenia, 15.4%; small intestinal perforation, 7.7%; catheter site dermatitis, 7.7%; gastroenteritis, 7.7%; lower respiratory tract infection, 7.7%; and postoperative wound infection, 7.7%. The registry information presented does not specify which group each listed term belongs to, so a group attribution should not be inferred. The percentages are registry-reported values and should be read in that context; the corresponding event counts and detailed term-specific denominators are not reported in the registry record.
Other adverse event fields list 36 at risk and 35 affected in the 10 mg/kg Q2W group, and 13 at risk and 13 affected in the 15 mg/kg Q3W group. Death counts are not reported in the registry record. These figures describe recorded safety information; they do not establish comparative risk or a causal relationship between a treatment and an event.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, open-label, non-randomized study evaluated bevacizumab with taxane therapy in female participants with advanced triple-negative breast cancer. The primary outcome was change in FACT-B score at Cycle 2, and the record describes safety, disease progression, survival and Karnofsky performance status as areas of evaluation. It also documents two bevacizumab schedules, with paclitaxel or docetaxel chosen at the treating physician’s discretion.
The record does not report the primary endpoint estimates, group-specific results, numbers analyzed or uncertainty measures. It therefore does not show the direction or magnitude of FACT-B change, nor how precisely that change was estimated. Although serious adverse event counts and selected percentages are listed, the information does not support a causal conclusion or a reliable comparison between the groups. Death counts are not reported in the registry record.
The design also limits what a between-group comparison could establish. Because allocation was non-randomized, and taxane choice was discretionary, differences between groups could arise from factors other than the bevacizumab schedule. The open-label design is relevant to a questionnaire-based outcome, but the record does not state whether treatment awareness affected responses or assessments.
In general, a registered endpoint and a treatment description are not substitutes for reported outcome estimates. Interpreting a clinical result requires knowing the estimate, its uncertainty, the analyzed population and the handling of missing data. Those details are not reported in the registry record for the primary endpoint. The available information supports a description of what the study set out to assess and how treatment was organized, but not a conclusion about whether scores changed or whether one regimen differed from the other.
13. Why This Trial Matters Statistically
This study illustrates why design details matter when interpreting clinical outcomes. The registry record labels the allocation non-randomized and the study open-label, while describing a parallel structure with two bevacizumab schedules. That combination means the groups are not automatically exchangeable: treatment selection and taxane choice could be related to participant or clinician decisions. A numerical difference between groups, if available, would need careful interpretation rather than being treated as a randomized treatment effect.
The primary outcome also shows the importance of defining what is measured. FACT-B captures health-related quality of life through a total score and multiple domains, and the registry record specifies a change from baseline at Cycle 2. Such a measure addresses a different aspect of outcome than survival or disease progression. Understanding its result would require the change estimates, the number of completed questionnaires and information about missing responses; these are not reported in the registry record.
The record also lists many outcomes but no analysis records. This makes the distinction between outcomes named in a registry and results actually available for statistical interpretation especially important. Without reported estimates, uncertainty and analysis details, the listed endpoints cannot be used to infer effect size or precision.
More broadly, the record is a reminder that statistical interpretation depends on transparency about allocation, outcome measurement, participant inclusion, missing data and multiplicity. These issues are not merely technical: they determine which comparisons are supported by the design and how much confidence readers can place in a numerical estimate. Here, the design and endpoint are described, but the primary outcome results and key analytic details are not reported in the registry record.
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.
Several trial-specific limitations affect interpretation. Allocation was non-randomized, and the treating physician selected paclitaxel or docetaxel. The record does not report how treatment schedules or taxane choices were decided, whether participant characteristics differed between groups, or whether an adjusted analysis was planned. Thus, the two groups cannot be treated as randomized comparators.
The study was open-label. The primary outcome was based on a participant questionnaire, and the registry record does not report whether questionnaire administration or analysis was blinded. It also does not report the number of participants with baseline and Cycle 2 scores, the number included in the endpoint analysis, or the method used for incomplete questionnaires. The endpoint population description is truncated after referring to questionnaire completion.
Most importantly, primary endpoint results are not reported in the registry record. There are no stated mean changes, standard deviations, confidence intervals or test results in the record details. The registry record lists 115 outcome measures and zero analysis records, but does not describe a statistical analysis plan, multiplicity approach or sample-size justification. Detailed results for listed secondary outcomes are also not reported in the registry record.
The treatment description for the 10 mg/kg Q2W group is truncated, and the serious adverse event terms are not linked to a specific group in the listed information. These gaps prevent a complete reading of treatment discontinuation conditions and term-specific group attribution. Together, these limitations restrict both quantitative interpretation of the primary endpoint and comparative interpretation of safety or efficacy outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer — NCT01094184.
- Registry record last updated 2018-03-22; status last verified 2017-08.
- Results first posted 2018-03-22.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed Phase 4, open-label, multi-center, non-randomized parallel study with an enrollment of 49. It evaluated bevacizumab with paclitaxel or docetaxel in female participants with advanced triple-negative breast cancer. The listed bevacizumab schedules were 10 mg/kg Q2W and 15 mg/kg Q3W; taxane choice and schedule were at the treating physician’s discretion.
The primary endpoint was change from baseline in FACT-B score at Cycle 2. Secondary outcomes included death, overall survival, disease progression, time to progression and Karnofsky performance status. The registry record includes selected serious adverse event counts and terms, but does not report the primary endpoint estimates, analysis population counts, missing-data methods, or a statistical analysis plan. The study design and endpoint are identifiable, while the size and precision of the primary result are not reported in the registry record.