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 Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC) (NCT02688803), a randomized phase 4 study. The primary outcome is Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02688803 |
| Phase | Phase 4 |
| Condition | Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ottawa Hospital Research Institute |
| Results posted | Yes |
2. Clinical Question
Population
Patients with triple-negative breast cancer being considered for chemotherapy in the neoadjuvant or adjuvant setting. The registry record says two patients were approached and randomized; further eligibility details are not reported in the registry record.
Intervention
An integrated consent model for random assignment among three standard-of-care chemotherapy regimens: dose-dense AC-P, dose-dense AC followed by weekly paclitaxel, and FEC-D.
Comparator
The alternative chemotherapy regimens in the three-arm comparison. The study was randomized and parallel, with no masking.
Primary question
Could patients approached about the study be recruited and randomized using the integrated consent model? The primary measure was the percentage of patients receiving chemotherapy in this setting relative to the number approached who subsequently agreed to randomization.
This is principally a feasibility question, not a test of which regimen is more effective. The study aimed to compare established treatment options in a setting where the registry description says that a single worldwide standard regimen was not established. It also sought to examine recruitment through randomization among those approached. The record reports that two patients were approached and randomized, but says the study did not meet feasibility and accrual was closed early. A numerical primary-outcome estimate and a prespecified threshold for what would count as feasible are not reported in the registry record. The findings therefore describe a very small recruitment experience, rather than a reliable comparison of the regimens or a general estimate of recruitment performance.
3. Trial Design
NCT02688803 was a Phase 4, randomized, parallel-group study with no masking. The registry record lists three regimens: dose-dense AC-P; dose-dense AC followed by weekly paclitaxel; and FEC-D. Dose-dense AC-P consisted of doxorubicin and cyclophosphamide every two weeks for four cycles, followed by paclitaxel every two weeks for four cycles. The dose-dense AC regimen used the same initial drugs and schedule, followed by weekly paclitaxel for twelve cycles. FEC-D consisted of 5-FU, epirubicin, and cyclophosphamide every three weeks for three cycles, followed by docetaxel every three weeks for three cycles.
The study was intended to determine the feasibility of an integrated consent model for comparing these standard-of-care regimens in the neoadjuvant or adjuvant setting. Its primary outcome concerned the proportion of approached patients who agreed to randomization, rather than a clinical outcome such as tumor response or survival. Secondary outcomes listed in the record were completion of study treatment, hospitalization, and treatment delays.
The registry lists an enrollment of 2. It reports that two patients were approached and randomized, that the study did not meet feasibility, and that accrual was closed early. The study status is terminated. The recorded start date is 2016-08-30 and the primary completion is 2017-10. The specific randomization procedure, allocation ratio, recruitment setting, eligibility criteria, follow-up details beyond the primary outcome's one-year timeframe, and reason for termination beyond failure to meet feasibility 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 | Dose Dense AC-P | Dose Dense AC | FEC-D |
|---|---|---|---|
| STARTED | 1 | 0 | 1 |
| COMPLETED | 1 | 0 | 1 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
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: No participants were randomized to the Dose Dense AC group.
| Characteristic | Unit | Dose Dense AC-P | Dose Dense AC | FEC-D | Total |
|---|---|---|---|---|---|
| Participants analysed | 1 | 0 | 1 | 2 | |
| Age, Continuous | years | — | — | — | — |
| Sex: Female, Male: Female | Participants | — | — | — | 0 |
| Sex: Female, Male: Male | Participants | — | — | — | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
| Region of Enrollment: Canada | participants | 1 | — | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC, measured over One year.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns recruitment feasibility: the proportion of patients approached about the study who subsequently agreed to randomization while receiving chemotherapy in the neoadjuvant or adjuvant setting for triple-negative breast cancer. Its timeframe is one year. Such a measure can help assess whether a study design that offers a choice among standard regimens can enroll patients into a randomized comparison. It addresses the practical step between being approached and accepting random assignment, rather than whether one chemotherapy regimen produces better clinical outcomes.
The registry description reports that two patients were approached and randomized and states that the study did not meet feasibility. However, a numerical endpoint value, a denominator beyond the stated number approached, and a feasibility threshold are not reported in the registry record. Although the outcome title refers to the percentage of patients receiving chemotherapy, the outcome description defines the comparison using patients approached and those who agree to randomization. Without a posted numerical result and complete outcome details, a percentage should not be inferred or calculated.
As a general statistical point, a recruitment proportion is a binary outcome: each approached patient either agrees to randomization or does not. The proportion is useful for describing recruitment in the study, but its precision depends on the amount of information collected. The small reported recruitment experience limits what can be concluded about feasibility in other settings.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The clearest result in the registry record is operational: two patients were approached and randomized, the study did not meet feasibility, and accrual was closed early. This describes the conduct of the study, but does not establish why recruitment fell short. The record does not report a target recruitment rate, a threshold defining feasibility, or detailed recruitment counts by stage. A numerical estimate of the primary endpoint is therefore not reported in the registry record.
No analyses are listed. In particular, there is no reported statistical comparison among the three treatment regimens, and no comparative estimate of treatment completion, hospitalization, or treatment delays. The registry's primary purpose was feasibility, so an absence of efficacy analyses should not be read as evidence for or against any regimen. Similarly, the record's absence of posted inferential results is not evidence that the regimens have equivalent outcomes.
The adverse-event entries list zero participants at risk and zero affected in each regimen group, with no serious-event terms listed. These entries do not establish that no adverse events occurred. With two randomized participants overall and zero participants listed at risk in the adverse-event categories, the safety information is not interpretable as an assessment of event frequency. The record does not report treatment exposure or explain these zero entries.
General statistical interpretation depends on distinguishing an estimate from its uncertainty. A confidence interval expresses a range of values compatible with the observed data under a specified method; with very little information, estimates are generally imprecise. No confidence interval or primary-outcome estimate is reported in the registry record, so the amount of uncertainty cannot be quantified from a posted analysis. No p-value or model-based treatment comparison is reported either.
The study's early closure and limited recruitment mean that the registry record documents an unsuccessful feasibility effort as defined by its own statement, but does not provide enough detail to judge whether a revised consent approach, different recruitment conditions, or a larger study would have a different result. Such explanations and future outcomes are not reported in the registry record. The most defensible reading is limited to the recruitment experience and closure statement, without extrapolating to the effectiveness, comparative safety, or general acceptability of the chemotherapy regimens.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group design with no masking. Randomization is a general method for assigning participants by chance to study groups. In principle, it can reduce systematic differences between groups, but it does not guarantee balance, especially in a very small study. A parallel-group design means participants are assigned to one regimen rather than moving through several regimens as part of the comparison. The record does not report the randomization sequence, allocation concealment, or allocation ratio.
What does the primary measure estimate?
As a general matter, a recruitment proportion is calculated from a count of people accepting randomization relative to the number approached under a defined rule. The registry description frames the primary outcome around patients who receive chemotherapy and the approached patients who subsequently agree to randomization. The record says two patients were approached and randomized, but does not provide a numerical outcome result or further denominator detail. No percentage should be inferred from those statements. A clear operational definition matters because recruitment can be counted at different stages, such as initial approach, consent, randomization, or treatment initiation.
What does a binary outcome mean?
The primary measure is classified as a count of participants with an event. In general, a binary outcome places each participant into one of two categories, such as accepting or not accepting randomization. A count alone is not enough to interpret a rate: it must be paired with the appropriate denominator. The denominator must correspond to the population at risk of the event and the period over which it is assessed. The registry record gives a one-year timeframe, but does not report a detailed analysis population or a numerical endpoint estimate.
How should uncertainty be understood?
In general, a point estimate is the single value calculated from the observed study data, while a confidence interval communicates uncertainty around that estimate under a stated statistical method. A narrow interval indicates greater precision than a wide interval, but precision is not the same as clinical importance. For a recruitment proportion based on very few participants, the estimate would ordinarily be highly uncertain. No confidence interval, standard error, or other uncertainty measure for the primary outcome is reported in the registry record. No p-value is listed; a p-value would address compatibility with a specified null hypothesis under model assumptions, not the practical importance of feasibility.
Were comparative treatment effects estimated?
The treatment groups involved three regimens, but the recorded primary question was recruitment feasibility. The registry lists no analyses. Consequently, it reports no treatment-effect estimate, confidence interval, or test comparing the regimens. General methods for comparing binary outcomes might use a difference or ratio of proportions, but selecting a method requires a defined endpoint, complete group-specific counts, and an analysis plan. Those elements are not reported as analyses in the registry record, and no new comparisons can be reconstructed from the information available.
What do the planning assumptions mean?
As a general concept, a sample-size calculation estimates how many observations would be needed to detect a specified effect under stated assumptions. It is a planning exercise, not an observed result and not evidence that a completed trial had a particular probability of detecting an effect. The registry's planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect framed as a stated fraction of an observed effect. It also distinguishes participants per arm for most outcomes from total events for time-to-event outcomes. These are planning assumptions, not a report of the trial's own design justification. The record does not report a trial-specific sample-size justification, and the primary outcome has no posted analysis from which to assess an observed effect. The two-arm assumption also does not describe the listed three-regimen comparison without additional specification.
What do zero entries in safety reporting establish?
In general, a safety count must be interpreted alongside the number of participants exposed or at risk, the length of observation, and the completeness of reporting. Zero events among a known, adequately observed group differs from a record showing zero participants at risk. Here, the adverse-event entries list zero participants at risk in every regimen group, as well as zero affected. These entries do not provide an interpretable estimate of safety or confirm an absence of events. The registry record does not explain the entries or report treatment exposure.
Over-dispersion is a general concern when count data vary more than a simple statistical model expects; it can make standard errors too small if ignored. It is not possible to assess over-dispersion from the posted information, and no such model is reported. More broadly, no regression model, covariate adjustment, interim analysis, or statistical analysis plan is reported in the registry record. These methods therefore should not be attributed to the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary feasibility outcome and secondary outcomes for treatment completion, hospitalization, and treatment delays. It does not report an analysis plan describing how these outcomes would be tested, whether any outcome had priority beyond its designation, or how multiplicity would be handled. In general, testing multiple outcomes can increase the chance of at least one apparently notable result by chance. No adjustment for multiple comparisons is reported, but with no analyses listed, there are no posted tests to interpret or adjust.
Missing-data rules, participant-level outcome availability, and methods for handling incomplete follow-up are not reported in the registry record. The same is true for the analysis populations: the record does not specify whether analyses were planned for all randomized participants, those who started treatment, or another defined group. Such definitions matter because excluding participants after randomization can affect the interpretation of group comparisons.
The registry reports two patients approached and randomized, but does not provide a participant flow account or outcome counts for the secondary measures. The adverse-event entries show zero participants at risk in each treatment group, so they cannot be treated as complete event surveillance. The record does not report reasons for missing outcome information, deviations from assigned treatment, or an approach to incomplete data. No conclusions about missingness or analysis populations can be drawn beyond noting that these details are not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The record documents a small randomized feasibility study that did not meet feasibility and closed accrual early. It records that two patients were approached and randomized. These registry entries describe the recruitment experience captured in the registry; they do not provide a robust estimate of recruitment performance beyond that experience. The specific feasibility threshold, a complete numerical primary outcome, and the reason recruitment was insufficient are not reported in the registry record.
The study does not establish whether dose-dense AC-P, dose-dense AC followed by weekly paclitaxel, or FEC-D is preferable. No treatment-effect analyses are listed, and the enrolled sample is too limited to support an informative comparative assessment from the reported information. The lack of posted comparative results does not show that the regimens are equal, nor does it show that one is better.
Likewise, the adverse-event entries cannot be interpreted as evidence that no harms occurred, because zero participants are listed at risk in each group. The record does not report enough treatment exposure or safety follow-up detail to characterize adverse events.
In general, feasibility results can inform whether recruitment and trial procedures warrant refinement, while efficacy and safety questions require outcome data and an analysis appropriate to those questions. The registry record establishes that this study did not meet its feasibility objective, but does not identify which part of the approach caused difficulty or predict the outcome of another study. It should be read as a report of this trial's limited recruitment and early closure, not as a conclusion about treatment benefit, treatment equivalence, or the broader feasibility of integrated consent.
12. Why This Trial Matters Statistically
This study matters statistically because it separates the practical question of recruiting participants from the clinical question of comparing treatments. Randomized studies can only estimate comparative outcomes if enough participants enter the comparison and relevant outcomes are observed. The registry's report of two patients approached and randomized, followed by early closure because feasibility was not met, illustrates how recruitment can limit what a trial can answer before treatment effects can be assessed.
The endpoint is about acceptance of randomization after approach, so its interpretation depends on defining the denominator and recruitment stages consistently. A count of randomized participants without a fully reported endpoint calculation does not show how often eligible or approached patients accepted participation in a broader population. Detailed reporting of screening, approach, consent, randomization, and treatment initiation can help readers locate where recruitment succeeds or falls short. Those details are not reported in the registry record.
The record also shows why empty or zero-valued safety entries need context. A count without a meaningful at-risk denominator and exposure information cannot describe event frequency. More generally, no analysis can compensate for missing outcome reporting or very limited information. Confidence intervals and statistical tests do not resolve ambiguity about who was counted or what outcome was measured.
The study's statistical contribution is therefore primarily a feasibility signal: the integrated-consent study did not meet feasibility and recruitment ended early. It does not supply evidence to compare the three regimens. This distinction helps prevent a failed recruitment effort from being mistaken for a negative or inconclusive treatment-effect finding. It also underscores the value of reporting prespecified feasibility criteria, recruitment flow, outcome definitions, and analysis methods so that future readers can interpret what a study was able to establish.
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 main limitation is the very limited recruitment reported: two patients were approached and randomized, and accrual was closed early after the study did not meet feasibility. A numerical primary-outcome estimate and a threshold for feasibility are not reported in the registry record, making it difficult to quantify the extent of the shortfall. The registry does not provide a full account of the number screened, eligible, approached, declining, randomized, or starting assigned treatment.
The primary outcome title and description emphasize related but not identical ideas: the title refers to patients receiving chemotherapy, while the description relates the measure to approached participants who agree to randomization. A clearly stated numerator and denominator would help resolve exactly what was counted. Further endpoint details are not reported in the registry record.
There are no listed analyses, and results for the secondary outcomes are not reported. The record does not describe missing-data handling, analysis populations, a trial-specific sample-size justification, or a statistical analysis plan. It also does not report whether interim analyses were planned. The adverse-event records list zero participants at risk across all three groups, so they do not permit meaningful safety interpretation.
The three-arm structure and the generic planning assumptions referring to equal allocation between two arms do not provide a complete account of any trial-specific planning approach. The record does not report how participants were allocated among the three regimens. Finally, the reason the study failed to meet feasibility, beyond the stated early closure, is not reported in the registry record. The available information cannot identify whether recruitment barriers were related to the consent model, study setting, eligibility, or other factors.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC) — NCT02688803.
- Registry record last updated 2025-12-04; status last verified 2025-11.
- Results first posted 2025-12-04.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
NCT02688803 was a Phase 4 randomized, parallel-group study with no masking, designed to examine the feasibility of an integrated consent model for comparing three chemotherapy regimens for triple-negative breast cancer in the neoadjuvant or adjuvant setting. The regimens were dose-dense AC-P, dose-dense AC followed by weekly paclitaxel, and FEC-D. The primary outcome concerned agreement to randomization among patients approached, with a one-year timeframe.
The registry reports that two patients were approached and randomized. It states that the study did not meet feasibility and accrual was closed early; the study status is terminated. Treatment completion, hospitalization, and treatment delays were listed as secondary outcomes. No analyses are listed, and a numerical primary-outcome estimate, comparative treatment results, and interpretable safety findings are not reported in the registry record. The record does not report the feasibility threshold, detailed recruitment flow, analysis plan, or trial-specific sample-size justification.