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 Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response (NCT02280252), a na phase 2 study. The primary outcome is Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02280252 |
| Phase | Phase 2 |
| Condition | Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 69 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer, treated at three international academic centers. The study title identifies the disease setting as locally advanced breast cancer. The record reports enrollment of 69, but says that no study data are available; it does not provide analyzed participant characteristics or an analysis population.
Intervention
The clinical question concerns concurrent paclitaxel and radiation. The record lists paclitaxel and radiation therapy as interventions and names a single group, Concurrent Paclitaxel and RT. The arm description also mentions paclitaxel or Abraxane administration, but the available description is incomplete. The record does not provide participant-level treatment exposure or adherence data.
Comparator
No separate control group or comparator is reported. The registry identifies the study as single-group and gives no randomized allocation. Thus, the record does not support a like-for-like comparison of concurrent treatment against another treatment strategy or against a control group.
Primary question
The stated primary aim is to test the clinical effectiveness of concurrent paclitaxel and radiation in this cohort. The description says that local recurrence, regional recurrence, and overall survival will be measured over a timeframe of 4.5 years. The record does not report results for these outcomes, so it cannot answer whether the outcomes were frequent, how long participants remained free of events, or how precisely any treatment effect was estimated.
The registry also lists pathological response rate and molecular biology and genomic studies among secondary outcomes. These outcomes concern tumor response and potential biomarkers, but no results are available for them either. The clinical question is therefore identifiable from the study aims, while the answer based on observed participant outcomes is not reported in the registry record.
3. Trial Design
This was a phase 2, single-group study listed as completed. The registry gives an enrollment of 69 and describes a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer treated at three international academic centers under uniform conditions. The record names NYU Langone Health as sponsor. Its listed start is 2005-03 and its primary completion date is 2018-12-20.
The intervention was concurrent paclitaxel and radiation therapy. The registry lists no masking and no randomized allocation. Because the study is single-group, there is no separate control arm in the record. A comparison between the treated cohort and an unobserved or external group cannot be treated as a randomized treatment contrast. The record does not give a comparator-based design or describe a control condition.
The primary outcome description refers to local recurrence, regional recurrence, and overall survival, with a timeframe of 4.5 years. The registry lists pathological response rate, molecular and genomic studies of core biopsies, and patient demographics as secondary outcomes. It does not specify a primary outcome measure, unit, or dispersion measure. The operational definitions and event-counting rules for recurrence and survival are not reported in the registry record.
The arm description includes a preoperative treatment period and mentions paclitaxel or Abraxane administration, but the text is truncated. It is therefore not possible to reconstruct the complete regimen or determine from this record how treatment varied among participants. The record also notes that the principal investigator and study team left the institution, that attempts to contact them were unsuccessful, and that no study data are available. As a result, the registry design can be described, but trial conduct, participant flow, and outcomes cannot be verified from posted study data.
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 | Concurrent Paclitaxel and RT |
|---|---|
| STARTED | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
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: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
| Characteristic | Unit | Concurrent Paclitaxel and RT |
|---|---|---|
| Participants analysed | 0 | |
| Sex: Female, Male: Female | — | |
| Sex: Female, Male: Male | — | |
| Race (NIH/OMB): American Indian or Alaska Native | — | |
| Race (NIH/OMB): Asian | — | |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | — | |
| Race (NIH/OMB): Black or African American | — | |
| Race (NIH/OMB): White | — | |
| Race (NIH/OMB): More than one race | — | |
| Race (NIH/OMB): Unknown or Not Reported | — |
6. Primary Endpoint
The registry lists the primary outcome as Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort, measured over 4.5 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome description states that the study would test the clinical effectiveness of concurrent paclitaxel and radiation. It names local recurrence, regional recurrence, and overall survival as outcomes to be measured over 4.5 years. These are clinically interpretable events or time-to-event outcomes: recurrence describes return of disease in specified locations, while overall survival concerns survival over time. The registry record does not specify the precise endpoint definitions, whether outcomes were measured as event counts or time to event, or how censoring was handled.
In general, recurrence and survival outcomes are used to describe disease control and follow-up outcomes that matter to clinical research. Time-to-event methods can account for participants who have different lengths of observation, provided the event and censoring information is available and assumptions are appropriate. That is a general explanation, not a description of an analysis performed in this study.
No primary endpoint result, estimate, confidence interval, or p-value is reported. The registry also lists pathological response rate as a secondary outcome, but does not provide its result. Consequently, the endpoint aims can be described, but neither the observed outcome rates nor the precision of any estimate can be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies the study question and design but does not provide the clinical outcome data needed to quantify results. Although enrollment is listed as 69 and the study status is completed, the primary outcome population field explicitly says that no study data are available. There are no reported counts of local or regional recurrence, survival estimates, pathological response results, treatment effects, confidence intervals, or hypothesis-test results. No effect size should therefore be inferred from the registry entry.
The absence of a comparator is also important for interpretation. A single-group study can describe outcomes among participants who received the study intervention if those outcomes are available. It cannot, by itself, separate the treatment effect from other explanations for the observed course, such as the characteristics of the enrolled cohort or other aspects of care. Since even the cohort outcomes are unavailable in this record, descriptive outcome estimates cannot be made either.
The registry’s entry of zero in the adverse-event group fields should not be interpreted as evidence that no adverse events occurred. The same record states that no study data are available. Without reported safety results and clear information on collection and reporting, those zero fields do not establish the absence of serious or other adverse events.
There is no reported analysis population, participant flow, follow-up completeness, or outcome-specific denominator. Therefore, enrollment cannot be assumed to equal the number included in any outcome analysis. It is not possible to assess loss to follow-up, missing outcome data, exclusions, or whether participants were analyzed according to their assigned or received treatment.
The sample-size assumptions described for planning illustrations are not the study’s own design justification. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a fraction of an observed effect. Time-to-event illustrations use a total event count, while other illustrations use participants per arm. These assumptions do not match the registry’s single-group design, and no observed effect or trial outcome is available in the record to anchor an illustration. Such calculations are planning scenarios, not observed power or evidence about this study’s results.
Overall, the registry supports a description of the intended research question and broad design. It does not support a conclusion about the magnitude, direction, or precision of clinical outcomes. The sponsor’s own analysis cannot be compared with a recalculation because no sponsor results or summary statistics are reported in the registry record.
9. Statistical Methods Explained
The study is listed as a single-group phase 2 study, not as a randomized comparison. That distinction determines what statistical conclusions would be possible if outcome data were available. A single-group analysis could describe the outcomes observed in the enrolled cohort. Without a concurrent control group, a difference attributable to treatment cannot be isolated through a randomized between-group contrast. This is a general design principle; no outcome analysis is reported for this study.
What would a confidence interval convey?
In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the statistical method. A narrow interval indicates greater precision than a wide interval, while both the estimate and interval are needed to judge the direction and size of an association or effect. The registry record contains no endpoint estimates or confidence intervals, so precision cannot be evaluated for recurrence, survival, pathological response, or safety.
Why do endpoint definitions matter?
For recurrence and survival, the event definition determines what is counted. Time-to-event analysis also requires information about when an event occurred and when observation ended for participants without a recorded event. Censoring is the statistical handling of incomplete event-time observation; it is not equivalent to knowing that an event did not occur. These are general considerations. The registry names local recurrence, regional recurrence, and overall survival but does not report operational definitions, event dates, censoring rules, or analysis methods.
What can a single-group study estimate?
In general, a single-group study can estimate a response proportion or describe event timing within its cohort when the relevant observations and denominators are reported. Such estimates describe that cohort. Without a suitable comparator, they do not by themselves identify what would have happened to the same participants under another treatment strategy. The registry does not provide the observations needed even for a cohort-level estimate, so no response proportion or event rate can be calculated.
How should planning illustrations be understood?
In general, sample-size planning asks how much information a future design might need to detect a specified effect under stated assumptions. The registry’s planning assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. They define the target effect as a stated fraction of the observed effect. For time-to-event calculations, the planning quantity is total events using the Schoenfeld method; other calculations are expressed as participants per arm. Those are assumptions for planning illustrations, not observed trial findings.
The two-arm and equal-allocation assumptions do not correspond to the listed single-group study design. No observed effect is available in the registry record, so the illustrations cannot be interpreted as estimates of the study effect. A planning sample size is not observed power: observed power is not a substitute for reporting an estimate and its uncertainty, and the registry does not provide those results.
What does missing analysis information prevent?
Statistical interpretation depends on knowing which participants contributed to each endpoint, how missing observations were handled, and which model or estimator was used. The registry does not report an analysis population, denominators, missing-data procedures, or analysis methods. It also reports no analyses in the registry entry. Therefore, it is not possible to reproduce an analysis, assess model assumptions, or determine whether any adjustment was made.
Over-dispersion is a general concern when count variability exceeds what a chosen count model assumes; ignoring it can make uncertainty estimates too small. That concept cannot be evaluated for this study because no count outcomes or model results are reported. Likewise, no assumption about proportional hazards, competing events, or adjustment for prognostic variables can be attributed to the study from the available record.
The methodological conclusion is limited but clear: the registry gives the broad design and planned outcome areas, while the analysis details and results needed for statistical inference are not reported in the registry record. General statistical concepts explain what would be required to interpret such results; they do not supply missing study findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcome areas: the primary description refers to local recurrence, regional recurrence, and overall survival, while secondary outcomes include pathological response rate, molecular biology and genomic studies of core biopsies, and patient demographics. The record does not explain whether these outcomes formed a prespecified hierarchy, whether any were combined into a composite, or how multiplicity was handled. A multiplicity adjustment or testing strategy is not reported in the registry record.
In general, testing multiple outcomes can increase the chance of at least one apparently unusual result when each is considered separately. A prespecified hierarchy, adjustment, or clearly descriptive interpretation can help readers understand how multiple analyses were treated. No such plan or results are available for this study, so it is not possible to assess whether multiplicity affected interpretation.
Missing-data methods and analysis populations are not reported. The registry says that no study data are available and provides no participant flow, endpoint denominators, follow-up completeness, or exclusions. It is therefore unknown how many participants contributed to any outcome analysis, or whether missing observations were handled by exclusion, imputation, censoring, or another approach. These methods should not be assumed.
In general, missing outcome data can affect both the estimate and its uncertainty, particularly if the probability of missingness is related to participant characteristics or outcomes. That is a general statistical concern, not an assertion about what occurred in this trial. The registry record does not provide the information required to evaluate it.
Analysis populations such as intention-to-treat, per-protocol, or safety populations are not identified. The enrollment figure should not be treated as an analysis denominator. No statistical analysis plan, interim analysis information, or missing-data strategy is reported in the registry record.
11. What the Result Does, and Does Not, Mean
The registry record establishes that a completed phase 2, single-group study was intended to evaluate concurrent paclitaxel and radiation in a multiethnic cohort with newly diagnosed stage 2B-3C breast cancer. It identifies recurrence and overall survival as primary outcome areas and lists pathological response and molecular studies among secondary outcomes. Those details describe the research question, not its findings.
The record does not report study outcome data. Accordingly, it does not show how often recurrence or pathological response occurred, what survival was observed, or whether outcomes were estimated precisely. It also does not provide a comparison that could establish a relative treatment effect. No conclusion about treatment benefit, lack of benefit, or harm follows from the missing results.
In general, an outcome estimate is more informative when accompanied by a measure of uncertainty and a clear description of the analysis population, endpoint definition, and follow-up. Those elements allow readers to distinguish an observed pattern from uncertainty due to limited information, and to understand which participants and events contributed. The necessary estimates and analysis details are not reported in the registry record.
The adverse-event fields marked as zero do not resolve this limitation. The registry separately states that no study data are available. Without reported safety observations and their denominators, the zero entries should not be read as confirmation that no adverse events occurred.
The appropriate interpretation is therefore about reporting availability: the registry identifies an important clinical research question and broad design, but does not make the trial’s results available for statistical assessment. Any sample-size planning illustration is not a trial result and cannot fill that gap. Readers should distinguish the planned outcomes from observed outcomes and avoid treating enrollment or completion status as evidence of efficacy or safety.
12. Why This Trial Matters Statistically
This study is statistically informative as an example of why a registry entry and an outcome report serve different purposes. The record captures the intended question, broad population, intervention, design, and outcome areas. It also identifies the study as completed and gives enrollment. Those details help characterize the research, but they do not provide the event observations or estimates needed to assess clinical outcomes.
The single-group design is central to interpretation. Even with complete outcome reporting, a cohort without a concurrent comparator primarily supports description of outcomes in that cohort, not a randomized estimate of what the intervention changed relative to another strategy. Since this registry record contains no outcomes, even descriptive estimates are unavailable.
The case also illustrates why numerical planning outputs must be read in context. The planning assumptions describe equal allocation between two arms, while the study is listed as single-group. Planning illustrations are not findings, and they are not evidence that the study had adequate precision or observed power. Without outcome data, an observed effect cannot be assessed against any planning scenario.
Finally, absence of results and absence of events are not the same thing. The record’s zero adverse-event fields do not substitute for a safety analysis when the record states that study data are unavailable. Clear outcome reporting, denominators, follow-up information, and analysis methods are needed to interpret both benefits and harms. This registry entry makes the reporting gap explicit, which is itself important for evaluating what can and cannot be learned from the study record.
13. 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 most consequential limitation is that the registry states that no study data are available. There are no posted outcome results with which to estimate recurrence, survival, pathological response, or adverse events. No effect estimates, confidence intervals, p-values, or outcome denominators are reported. Statistical precision and the direction or size of any observed association cannot be assessed.
The record identifies a single-group design and no randomized allocation. No separate control group is reported, so a comparative treatment effect cannot be estimated from the described design. Even if cohort outcomes were available, interpreting them as caused by the intervention would require caution because the record does not provide a randomized comparison.
The primary outcome description names local recurrence, regional recurrence, and overall survival, but does not define them operationally or state the analysis method. The timeframe is listed as 4.5 years, but actual participant follow-up and completeness are not reported. The record does not state how deaths, censoring, or incomplete observation were handled.
The registry reports that the principal investigator and study team left the institution and that attempts to contact them were unsuccessful. This limits the ability to clarify the incomplete arm description, verify conduct, or obtain results. The intervention description is truncated and mentions paclitaxel or Abraxane, leaving the complete regimen and treatment exposure unclear from the record.
Participant flow, analysis populations, missing-data procedures, and multiplicity handling are not reported. The enrollment entry cannot be assumed to be an endpoint denominator. The adverse-event fields show zero entries, but, in the context of unavailable study data, they cannot establish that no events occurred. These limitations concern what the registry record makes available; they do not establish what did or did not happen during the trial.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response — NCT02280252.
- Registry record last updated 2020-11-23; status last verified 2020-11.
- Results first posted 2020-11-23.
- 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.
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17. Record Summary
NCT02280252 is a completed phase 2, single-group study sponsored by NYU Langone Health. It concerns concurrent paclitaxel and radiation for newly diagnosed stage 2B-3C breast cancer in a prospective multiethnic cohort treated at three international academic centers. Registry enrollment is 69. The listed start is 2005-03 and primary completion date is 2018-12-20.
The primary outcome description names local recurrence, regional recurrence, and overall survival over a timeframe of 4.5 years. Secondary outcomes include pathological response, molecular and genomic studies, and patient demographics. No separate comparator is reported. The registry states that the principal investigator and study team left the institution, contact attempts were unsuccessful, and no study data are available. Consequently, outcome estimates, analysis methods, and safety findings cannot be assessed from the registry record.