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 Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer (NCT00364611), a non-randomized phase 2 study. The primary outcome is Progression-free Survival (PFS) Rate: Percentage of Participants With PFS.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00364611 |
| Phase | Phase 2 |
| Condition | Breast Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 73 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sanofi |
| Results posted | Yes |
2. Clinical Question
Population
Participants with metastatic breast cancer entering first-line treatment were eligible for the study. The registry describes the primary analysis population as all registered participants, regardless of whether they received study drug or had a post-baseline tumor assessment. Participants were stratified according to HER2 status at enrollment.
Intervention
Participants with HER2-negative disease were assigned to docetaxel and bevacizumab, abbreviated DB. Participants with HER2-positive disease were assigned to docetaxel, bevacizumab, and trastuzumab, abbreviated DBT. The drugs were administered intravenously every 3 weeks until a treatment discontinuation criterion was met.
Comparator
There was no randomized comparator. The two regimens were used in different HER2 strata, so the DBT group is not a like-for-like control for the DB group. The registry describes the study as noncomparative and nonrandomized.
Primary question
The primary endpoint was the percentage of participants with progression-free survival at up to 6 months and 12 months after treatment initiation. The endpoint counts time to documented disease progression, symptomatic deterioration, or death, subject to the registry's stated censoring rules. The registry record does not report the endpoint estimates.
The study asks about progression-free survival during first-line treatment with these regimens in metastatic breast cancer. Its design is descriptive rather than a randomized test of one regimen against the other. HER2 status determined which regimen participants received, and HER2 status also defines the study strata. Consequently, differences between the groups, if considered, could reflect differences in the participants as well as differences in treatment. The design cannot isolate a treatment effect by directly comparing DB with DBT.
The registry lists confirmed overall response, confirmed clinical benefit, duration of response, overall survival, and adverse events among the secondary outcomes. These outcomes broaden the clinical description beyond progression-free survival, but their results are not reported in the registry record. The central question that can be evaluated from the record is therefore how the primary outcome was defined and how the study was structured—not the magnitude or precision of any observed efficacy result.
3. Trial Design
This was a prospective, multicenter, open-label, parallel-group pilot study in phase II. The registry lists enrollment as 73 and the study status as completed. The record gives a start date of 2006-08 and a primary completion date of 2011-06. It identifies Sanofi as the sponsor. These descriptors establish the broad setting and status, but the registry record does not report a detailed protocol or statistical analysis plan.
Allocation was nonrandomized and masking was none. Assignment followed HER2 status at enrollment: participants with HER2-negative disease received docetaxel and bevacizumab, while participants with HER2-positive disease received docetaxel, bevacizumab, and trastuzumab. Both regimens were given intravenously every 3 weeks until unacceptable toxicity, disease progression, or death met a treatment discontinuation criterion. The registry describes the study as noncomparative, which is important when interpreting any apparent separation between the treatment groups.
All efficacy and safety analyses used a June 2011 cutoff, according to the study summary. It also reports that all but one participant were off study treatment on 30 June 2011; one participant continued treatment until 11 March 2012, and adverse events for that participant were collected through 19 April 2012 and included in the safety analysis. These details describe the stated data collection window, but the registry record does not give the number of participants contributing to each endpoint at each assessment time.
The registry lists 7 outcome measures and 0 analyses. The primary endpoint is a percentage of participants with progression-free survival, while secondary outcomes cover response, survival, and adverse events. Outcome definitions are not equivalent to outcome results: the registry record does not report the primary endpoint estimates or the secondary outcome estimates. It also does not report the rationale for the enrollment target, the planned statistical methods in sufficient detail to reproduce an analysis, or a power calculation for the trial itself.
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: 103 participants signed the informed consent for this study. Of these, 73 were determined to be eligible for inclusion. One participant did not receive any study treatment.
Overall Study
| Stage | Docetaxel and Bevacizumab | Docetaxel, Bevacizumab and Trastuzumab |
|---|---|---|
| STARTED | 52 | 21 |
| TREATED (SAFTEY POPULATION) | 52 | 20 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 51 | 21 |
Reasons for not completing this period:
| Reason | Docetaxel and Bevacizumab | Docetaxel, Bevacizumab and Trastuzumab |
|---|---|---|
| Did not receive study medication | 0 | 1 |
| Adverse Event | 7 | 4 |
| Participant's Request | 3 | 4 |
| Disease Progression | 38 | 8 |
| Investigator decision | 2 | 2 |
| Found Ineligible | 1 | 0 |
| Presumed CR on Study | 0 | 1 |
| Receiving Liver Ablation | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent to treat population: all registered participants
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 | Docetaxel and Bevacizumab | Docetaxel, Bevacizumab and Trastuzumab | Total |
|---|---|---|---|---|
| Participants analysed | 52 | 21 | 73 | |
| Age Continuous | years | 56.2 (SD 10.78) | 52.8 (SD 12.65) | 55.2 (SD 11.37) |
| Age, Customized: <=65 years | participants | 41 | 17 | 58 |
| Age, Customized: Between 65 and 75 years | participants | 8 | 3 | 11 |
| Age, Customized: >=75 years | participants | 3 | 1 | 4 |
| Sex: Female, Male: Female | Participants | 52 | 21 | 73 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Eastern Cooperative Oncology: ECOG Performance Score is 0 | participants | 28 | 16 | 44 |
| Eastern Cooperative Oncology: ECOG Performance Score is 1 | participants | 24 | 5 | 29 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS) Rate: Percentage of Participants With PFS, measured over Up to 6 months and 12 months after treatment initiation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with progression-free survival at up to 6 months and 12 months after treatment initiation. Progression-free survival is defined from registration to the first documentation of progressive disease under RECIST, symptomatic deterioration, or death from any cause in the absence of documented progression. This endpoint combines evidence of disease progression with a clinically important deterioration or death, rather than measuring tumor response alone.
A time-to-event endpoint is useful when the timing of progression or death matters and participants may have different lengths of follow-up. It can incorporate event timing and censoring rather than treating every participant as if observation ended at the same time. Reporting the percentage with progression-free survival at specified time points provides an interpretable snapshot of the estimated course of the outcome. A confidence interval, when reported, conveys the statistical uncertainty around an estimate; it does not remove limitations in the study design or guarantee that the true value lies within the interval.
The registry specifies that participants without a progression-free survival event who were receiving unrelated anticancer therapy were censored at their last available tumor assessment date on study treatment. It also specifies censoring at registration for participants who did not receive study drug or had no post-baseline tumor assessment. These rules affect how participants contribute to the time-to-event analysis. However, the registry record does not report the percentages, confidence intervals, event counts, or other numerical results for the primary endpoint. The endpoint definition alone therefore cannot establish the observed progression-free survival in either treatment group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the trial design and endpoint definitions, but it does not report numerical results for progression-free survival. It gives no estimate of the percentage of participants with progression-free survival at up to 6 months or 12 months, and no confidence interval for either time point. The primary outcome therefore cannot be quantified from the record. It is not possible to assess the observed level of progression-free survival or the precision of an estimate from the registry information alone.
The record also does not report the results for confirmed overall response, confirmed clinical benefit, duration of response, overall survival, or adverse events as secondary outcomes. The presence of these outcomes in the registry indicates what the study intended to assess; it does not establish what was observed. The outcome count and absence of analysis entries do not substitute for estimates, event counts, or a description of analytic findings.
The design further limits what can be inferred from any comparison between the groups. Treatment assignment was determined by HER2 status, not random allocation. Thus, the DB group and DBT group represent different HER2 strata rather than exchangeable treatment groups. A difference in outcome between them could not be attributed to the addition of trastuzumab alone, because HER2 status and other group differences would be entangled with treatment assignment. The registry itself characterizes the study as noncomparative and flags that the arms are not a like-for-like control comparison.
The registry lists the safety groups as 52 participants at risk in the DB group and 20 in the DBT group. It records serious adverse events affecting 14 participants in the DB group and 4 in the DBT group. These counts describe the registry's safety entries; without comparable randomized groups and fuller information about follow-up and event ascertainment, they should not be treated as a causal comparison of safety. The registry also lists selected serious adverse-event terms with percentages, but does not give enough information in the record to determine the contribution of each term to an overall between-group safety contrast.
The most defensible reading is limited: the registry documents a completed, open-label, nonrandomized phase II study with a defined progression-free survival endpoint and treatment assignment by HER2 status. It does not provide outcome estimates that would permit a quantitative assessment of efficacy or precision. Neither a favorable nor an unfavorable efficacy conclusion follows from the endpoint definitions or study completion status.
9. Statistical Methods Explained
What does the progression-free survival endpoint capture?
Progression-free survival is a time-to-event outcome. In this study, the clock starts at registration, and the event is the first of documented progressive disease under RECIST, symptomatic deterioration, or death from any cause when progression has not been documented. The endpoint therefore concerns how long participants remain free of these specified events. It is distinct from response rate, which concerns whether a defined tumor response is observed, and from overall survival, which concerns time to death.
The registry reports a percentage of participants with progression-free survival at up to 6 months and 12 months after treatment initiation. A time-point percentage is easier to interpret as a snapshot than a hazard ratio, but it does not describe every feature of the time-to-event distribution. The registry record does not report a hazard ratio or a complete progression-free survival curve. Nor does it report the primary estimates at the specified time points. A reader should distinguish the endpoint that was planned from the results that are actually reported.
What does censoring mean in this study?
Censoring occurs when a participant's event time is not observed within the available follow-up, so the analysis uses the information available up to a specified point rather than assigning an event time that was not observed. Under the registry's rules, participants without an event who were receiving anticancer therapy unrelated to study treatment were censored at their last available tumor assessment date on study treatment. Participants who did not receive study drug or lacked a post-baseline tumor assessment were censored at registration.
These rules describe how certain participants enter the time-to-event analysis, but they do not supply the number censored, the number of events, or the amount of follow-up. Censoring can be informative if the reason follow-up ends is related to a participant's risk of the event. That is a general statistical concern, not a conclusion about this trial. The registry record does not provide enough information to assess whether censoring was independent of future progression or death.
How should confidence intervals be read?
A confidence interval expresses uncertainty about an estimated quantity under the assumptions of the statistical method used. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. A confidence interval does not account automatically for selection bias, confounding, outcome measurement limitations, or other design issues. Here, the endpoint definition specifies a 95% confidence interval as the dispersion measure, but the actual endpoint confidence intervals are not reported in the registry record. Therefore, the precision of the primary estimates cannot be judged from this record.
In a nonrandomized study, confidence intervals describe sampling uncertainty around an estimate; they do not make groups comparable. Even a precisely estimated difference between the HER2-defined groups would not, by itself, identify a causal effect of adding trastuzumab. The assignment process and the distinct HER2 strata remain central to interpretation.
Why does over-dispersion matter for some outcomes?
As a general statistical concept, over-dispersion occurs when observed variability is greater than a model assumes. For count or rate outcomes, a model that assumes too little variability can understate uncertainty and make estimates appear more precise than warranted. Appropriate modeling may require accounting for the extra variation. The registry record does not describe an over-dispersion assessment or a model for such outcomes, and the primary endpoint is described as a percentage of participants with an event rather than a count-rate outcome. No specific claim about over-dispersion in this trial can be made from the record.
What can a planning illustration tell a reader?
A sample-size planning illustration is not an observed trial result and is not observed power. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. For time-to-event outcomes, the illustration uses a total event count, while other outcomes use participants per arm. Such an illustration can show how design requirements would change under stated assumptions, but it cannot replace the trial's own design justification or establish the precision of the completed study.
The registry record does not report the trial's own sample-size justification, and its arms were not formed through equal random allocation. Therefore, an equal-allocation planning scenario should not be confused with the study's actual allocation or treated as evidence that the study was designed with a particular power. The underlying outcome estimates and the trial-specific justification are not reported in the registry record.
What statistical analysis details remain unclear?
The registry specifies the primary outcome, population, time points, and censoring rules, but does not report a full analysis plan. It does not state whether any adjusted analyses were performed, how missing outcome data beyond the stated censoring rules were handled, whether assumptions were checked, or how multiplicity across outcomes was addressed. It also does not provide estimates, standard errors, event counts, or analysis populations for the secondary outcomes. These omissions mean that the registry record is insufficient to reproduce the analyses or independently verify the reported statistical methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary progression-free survival outcome at up to 6 months and 12 months, alongside secondary outcomes covering overall response, clinical benefit, duration of response, overall survival, and adverse events. Examining several outcomes or time points can increase the chance of a nominally notable finding arising by chance when many statistical tests are conducted. As a general statistical principle, a prespecified multiplicity strategy can control or otherwise address that concern. The registry record does not report a multiplicity adjustment, hierarchy among secondary outcomes, or a statistical testing plan, so it is not possible to determine how multiple comparisons were handled.
The record identifies the intent-to-treat population as all registered participants. That definition helps clarify who was intended to contribute to the primary analysis, including participants who may not have received study drug. The endpoint description also gives censoring rules for participants without a post-baseline tumor assessment and for those who did not receive study drug. It does not report how many participants fell into those categories or how missing assessments affected the results.
The registry's stated censoring rules are not a complete description of missing-data methods. The record does not report sensitivity analyses, imputation methods, or analyses under alternative assumptions about missing outcomes. It also does not provide outcome-specific analysis populations or explain whether those populations differed from the intent-to-treat population. Consequently, the impact of incomplete follow-up or missing assessments on the estimates cannot be evaluated from the record.
The registry lists 0 analyses, and numerical results for the primary and secondary outcomes are not reported in the registry record. This should be read as a limitation of the available record, not proof that no analyses were conducted. The detailed statistical plan, any interim analyses, and the rationale for the study's enrollment target are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Docetaxel and Bevacizumab | 14 | 52 | 26.9% |
| Docetaxel, Bevacizumab and Trastuzumab | 4 | 20 | 20.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Docetaxel and Bevacizumab | 52 of 52 |
| Docetaxel, Bevacizumab and Trastuzumab | 20 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | Docetaxel and Bevacizumab | Docetaxel, Bevacizumab and Trastuzumab |
|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 3 of 52 | 1 of 20 |
| Dehydration | Metabolism and nutrition disorders | 1 of 52 | 1 of 20 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 52 | 0 of 20 |
| Tachycardia | Cardiac disorders | 1 of 52 | 0 of 20 |
| Atrial fibrillation | Cardiac disorders | 0 of 52 | 1 of 20 |
| Duodenal ulcer | Gastrointestinal disorders | 1 of 52 | 0 of 20 |
| Gastric ulcer | Gastrointestinal disorders | 1 of 52 | 0 of 20 |
| Nausea | Gastrointestinal disorders | 1 of 52 | 0 of 20 |
| Abdominal pain | Gastrointestinal disorders | 0 of 52 | 1 of 20 |
| Asthenia | General disorders | 1 of 52 | 0 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Docetaxel and Bevacizumab | Docetaxel, Bevacizumab and Trastuzumab |
|---|---|---|---|
| Fatigue | General disorders | 36 of 52 | 13 of 20 |
| Alopecia | Skin and subcutaneous tissue disorders | 34 of 52 | 15 of 20 |
| Nausea | Gastrointestinal disorders | 28 of 52 | 10 of 20 |
| Diarrhoea | Gastrointestinal disorders | 23 of 52 | 8 of 20 |
| Dysgeusia | Nervous system disorders | 20 of 52 | 8 of 20 |
| Lacrimation increased | Eye disorders | 15 of 52 | 10 of 20 |
| Headache | Nervous system disorders | 16 of 52 | 9 of 20 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 17 of 52 | 8 of 20 |
| Nail disorder | Skin and subcutaneous tissue disorders | 18 of 52 | 7 of 20 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 17 of 52 | 6 of 20 |
Serious events with the highest arm-level rate: pleural effusion (5.8%), atrial fibrillation (5.0%), abdominal pain (5.0%), catheter site infection (5.0%), perirectal abscess (5.0%).
The registry lists 52 participants at risk for serious adverse events in the docetaxel-and-bevacizumab group and reports 14 participants affected. For the docetaxel, bevacizumab, and trastuzumab group, it lists 20 participants at risk and 4 affected. These are group-specific counts as recorded. The record does not report deaths in these safety entries; deaths are not reported in the registry record, which is different from evidence that no deaths occurred.
The listed serious adverse-event terms include pleural effusion at 5.8%, and atrial fibrillation, abdominal pain, catheter site infection, perirectal abscess, and pneumonia, each at 5.0%. Those percentages are recorded as presented; the registry entry does not explain in this summary how the percentages for individual terms were calculated or whether a participant could contribute to more than one term. They should not be added or interpreted as mutually exclusive categories.
Safety counts are descriptive and do not establish that a treatment caused an event. The groups were defined by HER2 status and were not randomized comparisons. Differences in group composition, follow-up, exposure, or event ascertainment could affect observed counts. The registry summary also notes that one participant continued treatment after the general June 2011 cutoff, with adverse events collected later and included in the safety analysis. The record does not provide a full event-level account or enough detail to compare risk causally.
12. What the Result Does, and Does Not, Mean
This trial's registry record is informative about the clinical question, treatment assignment, endpoint definition, and safety reporting structure. It describes a prospective, multicenter, open-label phase II study in which HER2-negative participants received docetaxel and bevacizumab and HER2-positive participants received docetaxel, bevacizumab, and trastuzumab. It also specifies progression-free survival as the primary outcome and explains the event and censoring definitions.
What the registry record does not provide is equally important. It gives no numerical estimate for progression-free survival at either specified time point, no confidence intervals for those estimates, and no reported results for the listed secondary outcomes. Without those figures, the magnitude of observed efficacy and its statistical precision cannot be assessed. Completion of the study and the presence of defined outcomes do not establish an outcome result.
The nonrandomized assignment prevents a like-for-like comparison of DB and DBT. Because treatment followed HER2 status, the groups differ by a factor that was central to treatment assignment. A contrast between their outcomes could not be interpreted as the isolated effect of adding trastuzumab. The study is described as noncomparative, and its two groups should be understood as separate treatment strata rather than randomized alternatives.
The registry's safety counts and event terms document reported adverse-event information, but they do not establish causation or provide a randomized safety comparison. Likewise, the planning assumptions describe a hypothetical design illustration, not observed power and not the study's actual design justification. The trial can therefore be described accurately in terms of its design and recorded methods, while conclusions about efficacy, comparative effectiveness, or causal safety effects remain unsupported by the registry record.
13. Why This Trial Matters Statistically
This study illustrates why treatment-group labels alone do not establish a valid comparison. The two regimens may appear to invite a contrast, but assignment depended on HER2 status, and the record explicitly describes the study as noncomparative. In statistical interpretation, the way participants enter treatment groups is as important as the outcomes measured. Without randomization or another defensible strategy to address confounding, a between-group contrast cannot isolate the treatment difference.
The trial also highlights the distinction between defining an endpoint and reporting its result. Progression-free survival is specified with an origin, event criteria, time points, analysis population, and censoring rules. Those details make the intended measurement more understandable. Yet without the estimates and uncertainty intervals, readers cannot judge the observed outcome or its precision. A clear endpoint is necessary for interpretation, but it is not a substitute for results.
Finally, the record shows why safety counts need context. The group-specific numbers of participants at risk and affected are useful descriptive information, while the listed serious adverse-event terms add detail about reported events. Still, unequal group composition, nonrandomized assignment, and the stated treatment-specific follow-up make a causal comparison inappropriate. This is a useful statistical case for separating what a registry can document—design, definitions, and recorded counts—from what the available information can support about treatment effects.
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 main trial-specific limitation is the nonrandomized assignment by HER2 status. Participants in the DB and DBT groups were not allocated to alternative treatments within a common comparison population. As a result, a contrast between those groups would mix treatment differences with differences associated with HER2 status and potentially other participant characteristics. The registry describes the study as noncomparative and explicitly warns that the arms are not a like-for-like control comparison.
The study was open-label, with no masking. The registry record does not describe blinded outcome assessment or other procedures that might limit the influence of knowledge of treatment assignment. This matters particularly for assessments involving clinical judgment or timing of evaluation, though the record does not establish that such influence occurred. The study was also a pilot phase II evaluation; the record does not report a trial-specific sample-size justification or provide information for assessing whether the study was sized to estimate each endpoint precisely.
Outcome information in the registry is incomplete for interpretation. Numerical primary and secondary results, confidence intervals, event counts, and detailed analysis populations are not reported in the registry record. The record states censoring rules but does not provide the number censored, follow-up distributions, or sensitivity analyses for missing outcomes. It also does not report how multiplicity was handled or provide a full statistical analysis plan. The precise effects of these limitations cannot be quantified from the registry information.
The safety summary includes group counts, selected event terms, and a later safety collection window for one participant, but does not provide a complete event-level dataset or establish comparable exposure and ascertainment between groups. These features limit descriptive interpretation as well as any causal comparison. Overall, the registry supports a careful account of study structure and endpoint definitions, but not a quantitative efficacy assessment or a comparative treatment-effect conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer — NCT00364611.
- Registry record last updated 2012-08-23; status last verified 2012-04.
- Results first posted 2012-08-23.
- 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
NCT00364611 is a completed, prospective, multicenter, open-label phase II pilot study of first-line treatment for metastatic breast cancer. Enrollment is listed as 73. HER2-negative participants were assigned to docetaxel and bevacizumab; HER2-positive participants were assigned to docetaxel, bevacizumab, and trastuzumab. The allocation was nonrandomized, and the registry describes the study as noncomparative.
The primary outcome was the percentage of participants with progression-free survival at up to 6 months and 12 months after treatment initiation. The registry defines progression-free survival by documented progression, symptomatic deterioration, or death, and specifies censoring rules. The primary and secondary outcome estimates are not reported in the registry record. Safety entries include group-specific counts of participants affected by serious adverse events and selected serious event terms, but they do not support a causal comparison between treatment groups.