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 Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy (NCT02971748), a na phase 2 study. The primary outcome is Disease Free Survival (DFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02971748 |
| Phase | Phase 2 |
| Condition | Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Breast Inflammatory Carcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 36 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hormone receptor-positive localized inflammatory breast cancer who did not achieve a pathological complete response after neoadjuvant chemotherapy. The registry lists anatomic and prognostic stage IIIB and IIIC breast cancer among the conditions. Its summary describes disease that has not spread to other parts of the body.
Intervention
Pembrolizumab given with hormonal therapy during or after radiation, as described in the official title. The listed pembrolizumab schedule is an intravenous infusion on day 1 of cycles repeated every 21 days, for up to 24 months if disease has not progressed and unacceptable toxicity has not occurred.
Comparator
There is no separate control group. The registry identifies the study as single-group, with allocation recorded as not applicable. It is not a randomized comparison, so there is no like-for-like control arm against which to estimate a treatment contrast.
Primary question
The primary endpoint is median disease-free survival, measured from treatment initiation to disease recurrence or death from any cause. The study asks how long patients remain free of those events during follow-up; however, the median and its confidence interval are not reported in the registry record.
3. Trial Design
This is a phase II, single-group study sponsored by M.D. Anderson Cancer Center. The registry lists an enrollment of 36 and describes the population as patients with hormone receptor-positive localized inflammatory breast cancer who did not achieve a pathological complete response to neoadjuvant chemotherapy. The listed conditions include anatomic and prognostic stage IIIB and IIIC breast cancer.
The study examines pembrolizumab in combination with hormonal therapy during or after radiation. Pembrolizumab is listed as the intervention. The treatment description specifies an intravenous infusion over 30 minutes on day 1, with cycles repeated every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. The registry record does not report the hormonal therapy regimen or further details of radiation timing.
Masking is listed as none, and allocation is not applicable. With no comparator arm, the study design cannot provide a randomized estimate of how outcomes differ from an alternative treatment or control. Its primary endpoint is disease-free survival, defined from treatment initiation to recurrence or death from any cause. Patients without an event are censored at their last disease assessment.
The record lists a start date of 2017-01-26, primary completion of 2025-12-10, and status active, not recruiting. These registry entries describe the study's status and planned follow-up, not its results. Although the primary endpoint has a stated follow-up timeframe of up to approximately 9 years, the registry record does not report a median disease-free survival estimate, its confidence interval, or sponsor analysis results.
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: 36 patients were accrued and assessed for eligibility and 31 patients were assigned to the cohort.
Overall Study
| Stage | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| STARTED | 31 |
| COMPLETED | 8 |
| NOT COMPLETED | 23 |
Reasons for not completing this period:
| Reason | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| Adverse Event | 12 |
| Withdrawal by Subject | 1 |
| Financial issue | 2 |
| Clinical progression | 8 |
Analysis population for the primary outcome, as defined in the registry: All treated patients were included in the DFS analysis.
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 | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|---|
| Participants analysed | 31 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 27 |
| Age, Categorical: >=65 years | Participants | 4 |
| Sex: Female, Male: Female | Participants | 31 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 25 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Disease Free Survival (DFS), measured over From treatment initiation through last available follow-up (up to approximately 9 years).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | years |
| Endpoint classification | Time-to-Event Analysis |
Disease-free survival (DFS) is the time from treatment initiation until disease recurrence or death from any cause. The registry states that patients without either event are censored at their last disease assessment. Censoring means that the exact time to a later event is not known for those patients; their follow-up contributes information up to the last assessment recorded.
The primary measure is the median DFS, with a 95% confidence interval, in years. A median is a summary of the time-to-event distribution: it describes the point at which the estimated distribution reaches its midpoint. The confidence interval communicates uncertainty around that estimate. In general, time-to-event outcomes are useful when follow-up duration varies and some participants have not experienced the event by the end of their observed follow-up.
The registry describes the analysis population as all treated patients and gives a timeframe from treatment initiation through last available follow-up, up to approximately 9 years. However, it does not report the median, confidence interval, or analysis results. As a result, the endpoint definition is available, but the observed DFS estimate and its precision cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies disease-free survival as the primary endpoint but does not report its median or 95% confidence interval. It also lists no analyses. Consequently, the posted record does not establish an observed DFS duration or provide an estimate of its precision. The endpoint definition and follow-up timeframe describe what was to be measured, not what the study found.
This is a single-group study, not a randomized comparison. Any outcome observed among treated patients would describe that study group; without a concurrent control arm, it would not by itself quantify the difference attributable to pembrolizumab or the combination regimen. Patient characteristics, prior treatment, disease course, and other influences cannot be separated from treatment effects through a randomized contrast in this design.
The registry describes pembrolizumab with hormonal therapy during or after radiation for patients whose cancer did not achieve a pathological complete response after neoadjuvant chemotherapy. It gives a pembrolizumab schedule, but further details of the hormonal therapy are not reported in the registry record. The brief summary provides a rationale for studying immunotherapy; that rationale is not evidence of efficacy.
The adverse-event summary reports 6 serious events among 31 at risk and 28 other events among 31 at risk for the listed group, as well as 9 deaths. The listed serious terms include colitis, diarrhea, and pneumonitis at 6.5% each, and hyperglycemia, back pain, and cough at 3.2% each. These safety entries do not establish that an event was caused by treatment. The registry information does not provide enough detail to interpret timing, overlap between event categories, or the relationship between deaths and treatment.
Overall, the record supports a description of the study question, design, endpoint, and selected safety entries. It does not support a conclusion about the magnitude or direction of a DFS result, because no DFS estimate or sponsor analysis is reported. The single-group design also limits comparative interpretation even if outcome estimates become available.
9. Statistical Methods Explained
The registry identifies a time-to-event primary endpoint: disease-free survival from treatment initiation to recurrence or death from any cause. It specifies a median and a 95% confidence interval as the planned summary, and states that patients without an event are censored at their last disease assessment. The statistical concepts below explain how such summaries are generally read; they do not describe unreported analyses from this trial.
What does a median time-to-event estimate describe?
In general, a time-to-event analysis uses information from participants with different lengths of follow-up. A participant who has an event contributes an event time. A participant who has not had an event by the last assessment contributes follow-up until that assessment and is censored. Censoring does not mean that the event never occurred; it means that the event time was not observed during the available follow-up.
The median is a point in the estimated time-to-event distribution, rather than an average of observed event times. It can summarize follow-up even when some patients are censored. Its interpretation depends on the event definition, completeness of follow-up, and the analysis methods. The registry states the event definition and censoring point, but does not report a median DFS result.
How should a confidence interval be read?
In general, a confidence interval communicates statistical uncertainty around an estimate. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. It is not a guarantee that the true value lies within the specific interval. The registry specifies a 95% confidence interval for median DFS, but the interval itself is not reported in the registry record. Therefore, precision cannot be assessed from the posted result information.
What does the single-group design allow?
The study is listed as single-group, with no masking and allocation not applicable. There is no randomized control group. In general, a single-group study can describe outcomes among participants who receive the study regimen, but it cannot create a randomized estimate of the difference between that regimen and a comparator. Comparisons with external experience, if attempted, would require information and assumptions not reported in the registry record and would not have the same protection against confounding as randomization.
The registry says all treated patients were included in the DFS analysis. That defines the stated analysis population, but does not reveal how many had events, how much follow-up was available, or how the analysis was conducted beyond the endpoint description. The record lists no analyses and reports no hazard ratio. It is therefore not possible to evaluate a sponsor-reported effect estimate or its statistical uncertainty.
What do the planning illustrations represent?
The record describes sample-size calculations as planning illustrations based on an observed effect, rather than the trial's own design. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event calculations, the record says the total number of events is used. These are hypothetical planning assumptions, not observed power and not evidence that this single-group trial randomized participants between two arms.
Because the record does not report an observed DFS effect estimate, those planning assumptions cannot be interpreted as a verified estimate of what the trial found. Planning calculations also depend on assumptions about the target effect and analysis; they do not replace actual results. No particular sample-size illustration or numerical result is reported in the registry information.
Why can event rates be difficult to compare?
In general, time-to-event outcomes depend on both event occurrence and the duration of observation. A group followed longer may have more opportunity to experience an event. Censoring methods account for incomplete event observation under their assumptions, but do not remove all uncertainty. Over-dispersion is a general concern in count outcomes when variability exceeds what a simple model assumes; it is not identified as a method or issue in the registry record for this endpoint.
The absence of a reported DFS estimate, confidence interval, and analysis description means that the statistical methods cannot be audited in detail from the record. The endpoint definition is clear, but the sponsor's analysis approach beyond that definition is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is identified as disease-free survival, and the registry lists two outcome measures overall. However, the record does not report an analysis plan, a testing hierarchy, or any adjustment for multiple comparisons. Whether multiplicity was addressed in the sponsor's statistical plan is not reported in the registry record. With no posted analysis results, it is not possible to assess how multiple outcomes or analyses were interpreted.
For the primary endpoint, the registry specifies that all treated patients were included in the DFS analysis. It also states that patients without an event were censored at their last disease assessment. This gives a basic description of the analysis population and handling of event-free follow-up. The registry does not report the amount of missing assessment information, reasons for missingness, or additional methods for handling missing data. Those details are not reported in the registry record.
The registry lists no analyses, and the median DFS, confidence interval, and sponsor-reported hazard ratios are not reported in the registry record. Thus, there is no inferential result to examine for multiplicity, missing-data sensitivity, or robustness across analysis populations. The stated population should not be mistaken for a complete description of every analysis decision; details beyond the recorded definition are unavailable.
In general, multiplicity matters when several outcomes or hypotheses are assessed because repeated testing can increase the chance of a false-positive finding if results are treated as independent confirmatory tests. Missing-data methods matter because incomplete follow-up can affect estimates if missingness is related to outcomes. Those are general statistical considerations, not claims about what occurred in this study. The registry record does not provide enough information to determine how either issue was handled beyond the endpoint's stated censoring rule.
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 |
|---|---|---|---|
| Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 6 | 31 | 19.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 9 of 31 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 28 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|---|
| Colitis | Gastrointestinal disorders | 2 of 31 |
| Diarrhea | Gastrointestinal disorders | 2 of 31 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 2 of 31 |
| Hyperglycemia | Metabolism and nutrition disorders | 1 of 31 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 31 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 31 |
| Flank Pain | Musculoskeletal and connective tissue disorders | 1 of 31 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 1 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 11 of 31 |
| Hypothyroidism | Endocrine disorders | 9 of 31 |
| Fatigue | General disorders | 9 of 31 |
| Hypertension | Vascular disorders | 9 of 31 |
| Nausea | Gastrointestinal disorders | 6 of 31 |
| Myalgia | Musculoskeletal and connective tissue disorders | 5 of 31 |
| Skin infection | Infections and infestations | 4 of 31 |
| Upper respiratory infection | Infections and infestations | 4 of 31 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 4 of 31 |
| Diarrhea | Gastrointestinal disorders | 3 of 31 |
Serious events with the highest arm-level rate: colitis (6.5%), diarrhea (6.5%), pneumonitis (6.5%), hyperglycemia (3.2%), back pain (3.2%).
The registry's adverse-event summary lists 6 serious events among 31 at risk and 28 other events among 31 at risk for the pembrolizumab and hormonal-therapy group. It also lists 9 deaths. These are the entries in the record; they should not be read as proof that the events or deaths were caused by study treatment. The record does not specify in the information the timing of events, the degree of overlap between categories, or the relationship of the deaths to treatment.
The listed serious terms are colitis, diarrhea, and pneumonitis, each at 6.5%, and hyperglycemia, back pain, and cough, each at 3.2%. These percentages are reproduced as recorded and should not be added together: the record does not establish that categories are mutually exclusive. Nor do the percentages alone describe event severity, duration, or clinical course. The adverse-event summary is a safety description, not a comparison with an untreated or alternative-treatment group. With a single group and no control arm, differences in risk attributable to treatment cannot be estimated from these entries alone.
12. What the Result Does, and Does Not, Mean
The study is designed to describe disease-free survival in patients with hormone receptor-positive localized inflammatory breast cancer who did not achieve a pathological complete response to neoadjuvant chemotherapy and received pembrolizumab with hormonal therapy. The registry defines DFS as time from treatment initiation to recurrence or death from any cause, and specifies a median with a 95% confidence interval. However, neither the median nor its confidence interval is reported in the registry record.
Therefore, the posted information does not show how long participants remained free of recurrence or death, how precise any estimate was, or whether the study met a statistical objective. No sponsor analysis or hazard ratio is reported. The registry's treatment rationale describes a possible role for immunotherapy, but a rationale is not a demonstrated clinical result.
The single-group design is also important to interpretation. Without a randomized comparator, observed outcomes cannot establish the difference between the study regimen and another treatment approach. The listed enrollment and study status describe the registry record, not treatment effectiveness. Likewise, the adverse-event entries describe reported safety information but do not by themselves establish causation or comparative risk.
In general, a complete interpretation of a time-to-event result would consider the estimate, its confidence interval, follow-up, event counts, and analysis methods together. Those result details are not reported in the registry record. The record can therefore be used to understand the clinical question and planned primary measure, but not to draw conclusions about the magnitude or direction of an observed DFS effect.
13. Why This Trial Matters Statistically
This study addresses a defined clinical setting: hormone receptor-positive localized inflammatory breast cancer after neoadjuvant chemotherapy without a pathological complete response. Its primary endpoint, disease-free survival, captures time to recurrence or death from any cause rather than a single measurement at a fixed visit. That makes the endpoint relevant to the course of disease over follow-up, while also requiring careful attention to censoring and follow-up duration.
Statistically, the single-group design sets an important boundary on interpretation. It can describe outcomes in the treated group, but it cannot provide a randomized comparison with an alternative. The registry's population and intervention description helps clarify whom the study addresses and what treatment approach it examines; the absence of a reported DFS result means that the central outcome cannot be assessed from this record.
The study also illustrates the difference between an endpoint definition and an endpoint result. The record specifies the DFS event, censoring rule, median, confidence interval, and analysis population. Those definitions support a clear account of what was intended to be measured. They do not supply the numerical estimate needed to judge its magnitude or precision.
Finally, the safety entries need to be read in their design context. They provide selected event counts and listed terms for the treatment group, but they do not establish attribution or comparative risk. For clinical researchers and biostatisticians, the key statistical point is that design, endpoint, and analysis results jointly determine what conclusions are supportable. In this record, the design and endpoint are described, while the principal efficacy estimate and sponsor analysis are not reported.
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 most consequential limitation for interpreting the primary outcome is that the registry record does not report the median DFS, its 95% confidence interval, event counts for that endpoint, or sponsor analysis results. Although the endpoint definition and follow-up timeframe are stated, the observed outcome and its precision cannot be assessed from the record.
The study is single-group, with no randomized comparator. Accordingly, even an outcome estimate for the treated group would not establish a treatment contrast or isolate the effect of pembrolizumab from other influences. The registry does not report a sponsor statistical plan, so details beyond the stated endpoint and analysis population are not available. Multiplicity procedures and additional missing-data methods are not reported in the registry record.
The official title describes pembrolizumab with hormonal therapy during or after radiation, but the intervention details list pembrolizumab and do not specify the hormonal therapy regimen or further radiation details. The registry's adverse-event entries do not, in the information reported, clarify event timing, overlap, attribution, or the relationship of deaths to treatment. The percentages for serious terms should therefore be read as listed descriptions rather than comparative risk estimates.
The record lists an enrollment of 36 and status active, not recruiting, but does not report the DFS results needed to judge whether the primary question has been answered. These limitations are specific to the information and design recorded; they do not imply that unreported analyses or details do not exist outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy — NCT02971748.
- Registry record last updated 2026-06-11; status last verified 2026-06.
- Results first posted 2026-01-22.
- 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.
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18. Record Summary
NCT02971748 is a phase II, single-group study sponsored by M.D. Anderson Cancer Center. It evaluates pembrolizumab with hormonal therapy during or after radiation in hormone receptor-positive localized inflammatory breast cancer after no pathological complete response to neoadjuvant chemotherapy. The registry lists enrollment of 36, no masking, and no comparator arm.
The primary endpoint is median disease-free survival in years, defined as time from treatment initiation to recurrence or death from any cause. Event-free patients are censored at their last disease assessment, and all treated patients are included in the stated DFS analysis population. The median, 95% confidence interval, and sponsor analysis results are not reported in the registry record.
The record lists status active, not recruiting, a start date of 2017-01-26, and primary completion of 2025-12-10. It also includes adverse-event counts and selected serious-event terms, which should not be interpreted as causal or comparative findings.