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 Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy (NCT02422498), a na phase 2 study. The primary outcome is Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02422498 |
| Phase | Phase 2 |
| Condition | Locally Recurrent/Metastatic Triple Negative Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 49 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with locally recurrent or metastatic triple-negative breast cancer are the stated population. The registry record describes a pre-treatment biopsy and identifies the primary outcome population as participants who have concluded study treatment and are no longer on study. Eligibility details beyond the condition are not reported in the registry record.
Intervention
The treatment is concurrent cisplatin and radiation therapy. The listed interventions are cisplatin, external beam radiation therapy, and biopsy of the target tumor. The biopsy is relevant to the study’s biomarker question: whether pre-treatment findings about homologous recombination repair status are associated with, or can predict, treatment response.
Comparator
The study is recorded as a single-group trial with no masking and allocation listed as not applicable. No separate control or comparison treatment arm is reported in the registry record. The title refers to RECIST 1.1 and PET Response Criteria as response measurement tools, but that does not establish a treatment comparator.
Primary question
The central question is whether pre-treatment biopsy results can predict response to cisplatin and radiation therapy. The primary outcome is titled as a response assessment involving RECIST 1.1 versus PET Response Criteria, with a timeframe of 2 years from baseline. The precise role of homologous recombination repair status in the primary outcome analysis is not detailed in the registry record.
3. Trial Design
This is a phase II, single-group study sponsored by Memorial Sloan Kettering Cancer Center. The registry lists enrollment as 49 and identifies the condition as locally recurrent or metastatic triple-negative breast cancer. The treatment arm is named Concurrent Cisplatin & Radiation Therapy. The listed interventions are cisplatin, external beam radiation therapy, and biopsy of the target tumor.
Allocation is recorded as not applicable, and masking is recorded as none. The study therefore does not present a randomized treatment comparison, and no separate control arm is described. Its stated purpose is to assess whether results from a pre-treatment biopsy can predict response to cisplatin and radiation treatment. That is a biomarker-response question within a treated group, rather than an estimate of the treatment’s effect relative to an untreated or alternative-treatment group.
The registry lists a start date of 2015-04-14 and a primary completion date of 2022-12-19. Its current status is active, not recruiting. The registry record does not report the protocol’s sample-size justification, recruitment flow, treatment delivery details, or the timing and frequency of assessments beyond the primary outcome timeframe. It also does not describe a statistical analysis plan or report analyses for the primary outcome.
The primary outcome is described as a count of participants, with response assessed using RECIST 1.1 and PET Response Criteria referenced in the outcome title. The outcome description specifically mentions RECIST 1.1 as a measurement tool. How the two response criteria relate to each other in the planned primary analysis is 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 | Concurrent Cisplatin & Radiation Therapy |
|---|---|
| STARTED | 49 |
| COMPLETED | 45 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Concurrent Cisplatin & Radiation Therapy |
|---|---|
| Inevaluable | 4 |
Analysis population for the primary outcome, as defined in the registry: All participants have concluded study treatment and are no longer on study.
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 | Concurrent Cisplatin & Radiation Therapy |
|---|---|---|
| Participants analysed | 49 | |
| Age, Continuous | years | 54 (30 to 74) |
| Sex: Female, Male: Female | Participants | 48 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 44 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 14 |
| Race (NIH/OMB): White | Participants | 27 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 |
| Region of Enrollment: United States | Participants | 49 |
6. Primary Endpoint
The registry lists the primary outcome as Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response), measured over 2 years from baseline.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome concerns treatment response, expressed as a count of participants. Its title refers to RECIST 1.1 versus PET Response Criteria (PRC) as measurement tools, and its timeframe is 2 years from baseline. The outcome description specifically names RECIST 1.1 as a measurement tool for treatment response. The listed outcome population consists of participants who have concluded study treatment and are no longer on study.
Response criteria make tumor change measurable through defined assessment rules. General statistical context: using an explicit criterion helps make response classification more consistent and allows a study to state how many participants meet the chosen definition. Different assessment criteria can classify response differently, so comparing measurement approaches may be informative when their relationship is a study question.
The registry record does not specify the precise response categories, the threshold for being counted as a responder, or how PET Response Criteria are incorporated into the primary outcome. It also does not report the observed response count or an analysis connecting biopsy-based homologous recombination repair status with response. As a result, the endpoint’s broad intent is apparent, but the operational definition and the reported result are not available in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s question and design, but it does not report the primary outcome result. It lists one outcome measure and no analyses. There is therefore no posted response count, estimate of the relationship between biopsy findings and response, or measure of precision to interpret. The study’s stated aim is to examine whether pre-treatment biopsy results can predict response to cisplatin and radiation therapy; the aim itself is not evidence that prediction was demonstrated.
The design is single-group, with allocation listed as not applicable and no masking. In general, a single-group biomarker study can describe response patterns among treated participants and assess whether response varies with a biomarker. Without a separate treatment comparison, however, it cannot by itself distinguish a marker of treatment-specific benefit from a marker associated with prognosis or other participant characteristics. The registry record does not report an analysis that resolves this distinction.
The outcome title names both RECIST 1.1 and PET Response Criteria, while the description specifically mentions RECIST 1.1. That wording leaves the measurement question incompletely specified: the record does not explain whether the criteria were intended to be compared, whether one was primary and the other supporting, or how any disagreement would be handled. The response threshold and the relationship between response classification and homologous recombination repair status are also not reported in the registry record.
Precision cannot be assessed without an outcome estimate and its uncertainty. General statistical context: a confidence interval describes a range of values reasonably compatible with the observed data under the analysis assumptions. A narrow interval can indicate greater precision than a wide interval, but neither its width nor the estimate is available in the registry record. No recalculated estimate can be made from the posted information.
The adverse-event counts are separate from the primary efficacy question. They describe events recorded for the treatment group, but the registry information does not establish that treatment caused an event. The record lists 40 deaths, but does not state their causes or provide a time-to-event analysis in the material available. The safety counts should therefore be read as descriptive registry entries, not as a causal comparison or a complete account of risk over time.
9. Statistical Methods Explained
The registry identifies the study as single-group, with no masking and allocation listed as not applicable. This design determines what the data can support: outcomes can be described among participants receiving concurrent cisplatin and radiation therapy, and the study’s stated biomarker question can be examined within that treated group. A treatment effect relative to another therapy or to no treatment cannot be estimated from a comparison arm that is not reported.
What does a participant count represent?
The primary outcome is recorded as a count of participants, and its general meaning is participants with an event or outcome. For a response endpoint, interpretation depends on how response is defined and which participants are included in the assessment. The registry describes response measurement using RECIST 1.1 and refers to PET Response Criteria in the outcome title. It does not report the response threshold, the classification rules, or the observed count. Without those details, the endpoint cannot be independently reconstructed from the registry record.
Why does the measurement rule matter?
General statistical context: an endpoint needs a clear operational definition before a count can be interpreted. Assessment criteria translate observations into categories, and alternative criteria may not classify every participant in the same way. When a study names more than one criterion, the analysis plan should explain whether the criteria are compared, whether one is primary, and how discordant assessments are handled. Those details are not reported in the registry record. This is especially relevant because the outcome title mentions both RECIST 1.1 and PET Response Criteria, while the description names RECIST 1.1.
How should uncertainty be understood?
General statistical context: an estimate summarizes the observed data, while a confidence interval conveys uncertainty about that estimate under the model and assumptions used. A p-value addresses compatibility between the data and a specified statistical null hypothesis; it does not measure the size or clinical importance of an association. Neither an estimate, confidence interval, nor p-value for the primary outcome is reported in the registry record. The record lists no analyses, so there is no sponsor analysis to compare with a recalculation.
What can a biomarker association show?
General statistical context: an association between a pre-treatment biomarker and response means the observed response pattern differs across biomarker values or categories, according to the specified analysis. Prediction additionally requires a defined model and an assessment of how well it predicts outcomes. A marker associated with response among treated participants does not, on its own, show that the marker identifies who benefits more from the treatment than from an alternative. That distinction usually requires an appropriate treatment comparison and a treatment-by-marker analysis. Such analyses are not reported in the registry record.
What do planning assumptions mean?
The registry record’s planning description characterizes any sample-size illustration as based on the observed effect, rather than as the trial’s own design. It states assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are planning assumptions, not a record of the study’s actual design; the study itself is listed as single-group. No observed primary effect or analysis is reported, so a planning illustration cannot be treated as evidence of an observed result or as observed power. The trial’s own sample-size justification is not reported in the registry record.
Why might model choice matter?
General statistical context: binary outcomes are often analyzed using models for event probabilities, while counts or rates may call for other approaches depending on how observations are collected. Over-dispersion matters when the variability in count data exceeds what a chosen model assumes; ignoring it can make uncertainty appear too small. The primary outcome is described as a participant count, but no fitted model, variance assumption, or statistical plan is reported. There is no basis in the registry record for saying that over-dispersion was assessed or that a particular model was used.
In short, the registry supports a description of the trial design and its intended response question. It does not supply the analysis details or outcome estimates needed to judge the strength, precision, or predictive performance of a biomarker association.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome measure and no analyses. It does not report whether the study assessed additional response definitions, biomarker thresholds, subgroup questions, or secondary hypotheses in a way that would create multiple statistical tests. A multiplicity adjustment or rationale for not adjusting is therefore not reported in the registry record.
General statistical context: when several hypotheses are tested, the chance of finding at least one apparently notable result can increase. A prespecified analysis plan can clarify which comparisons are confirmatory and how multiple testing is handled. The registry information does not describe such a plan, so it is not possible to determine whether multiplicity was relevant to the actual analyses or how it was addressed.
Missing outcome data and the analysis population also require care. The primary outcome population is described as participants who have concluded study treatment and are no longer on study, but the record does not give a participant flow, the number assessed for response, reasons for missing assessments, or the rule for handling missing response data. It does not report whether all enrolled participants were included in an analysis or whether exclusions were made. Those details are not reported in the registry record.
General statistical context: missingness can affect interpretation when the probability of an unavailable assessment is related to response or to participant characteristics. The direction and size of any resulting bias cannot be inferred without information about who was assessed and why data were missing. Since no primary analysis is listed, there is no reported analysis population or missing-data method to evaluate.
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 |
|---|---|---|---|
| Concurrent Cisplatin & Radiation Therapy | 12 | 49 | 24.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Concurrent Cisplatin & Radiation Therapy | 40 of 49 |
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 |
|---|---|
| Concurrent Cisplatin & Radiation Therapy | 45 of 49 |
Most frequent serious adverse event terms
| Event term | Organ system | Concurrent Cisplatin & Radiation Therapy |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 4 of 49 |
| Acute kidney injury | Renal and urinary disorders | 2 of 49 |
| Fatigue | General disorders | 2 of 49 |
| Back Pain | Musculoskeletal and connective tissue disorders | 1 of 49 |
| Breast infection | Infections and infestations | 1 of 49 |
| Confusion | Psychiatric disorders | 1 of 49 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 49 |
| Edema limbs | General disorders | 1 of 49 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 49 |
| Fever | General disorders | 1 of 49 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Concurrent Cisplatin & Radiation Therapy |
|---|---|---|
| Fatigue | General disorders | 25 of 49 |
| Anemia | Blood and lymphatic system disorders | 18 of 49 |
| Dermatitis radiation | Injury, poisoning and procedural complications | 18 of 49 |
| Nausea | Gastrointestinal disorders | 18 of 49 |
| White blood cell decreased | Investigations | 18 of 49 |
| Neutrophil count decreased | Investigations | 16 of 49 |
| Lymphocyte count decreased | Investigations | 13 of 49 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 8 of 49 |
| Hypocalcemia | Metabolism and nutrition disorders | 8 of 49 |
| Anorexia | Metabolism and nutrition disorders | 7 of 49 |
Serious events with the highest arm-level rate: anemia (8.2%), acute kidney injury (4.1%), fatigue (4.1%), back pain (2.0%), breast infection (2.0%).
For Concurrent Cisplatin & Radiation Therapy, the registry lists 49 participants at risk for serious adverse events and 12 participants affected. It lists 49 at risk for other adverse events and 45 affected. These are descriptive counts recorded for the group; the registry information does not establish that the treatment caused the events. No comparison group is reported.
The record lists deaths as 40. It does not report causes of death, timing, attribution, or a time-to-event analysis in the information available. The death count should not be interpreted as treatment-related mortality or as a rate, since the necessary timing and attribution details are not reported in the registry record.
The most frequently listed serious-event terms include Anemia at 8.2%, Acute kidney injury at 4.1%, and Fatigue at 4.1%. Back Pain, Breast infection, and Confusion are each listed at 2.0%. The denominator and event-collection details for these percentages are not reported in the registry record. General statistical context: adverse-event summaries may count participants, event occurrences, or events meeting a defined seriousness criterion; the collection and coding rules affect interpretation. These entries should be read as registry safety descriptions, not as comparative evidence.
12. What the Result Does, and Does Not, Mean
The record describes a study designed to examine a biomarker question in patients with locally recurrent or metastatic triple-negative breast cancer receiving concurrent cisplatin and radiation therapy. Specifically, the stated purpose is to assess whether findings from a pre-treatment biopsy can predict response. The study is phase II and single-group, and its primary outcome concerns response measurement using RECIST 1.1 and PET Response Criteria.
What the record does not establish is whether homologous recombination repair status predicted response, how accurately it did so, or how precise any association was. The registry lists one outcome measure but no analyses, and it does not report the primary response count or an effect estimate. A study’s stated objective is not a result. Without the reported analysis, readers cannot determine whether the observed data support the biomarker question.
Even if an association were reported, a single-group design would need careful interpretation. General statistical context: a biomarker can be associated with outcomes among treated participants without identifying who benefits specifically because of that treatment. A treatment-specific predictive claim is stronger than a within-group association and generally depends on a comparison that can distinguish predictive from prognostic patterns. No treatment comparison is described in the registry record.
The outcome wording also limits interpretation. The title refers to RECIST 1.1 versus PET Response Criteria, but the description specifically names RECIST 1.1. The record does not explain how the criteria were used together or define the response classification. The endpoint timeframe is 2 years from baseline, but the assessment schedule and handling of unavailable assessments are not reported.
Safety entries provide counts and listed serious-event terms, not causal attribution or a comparative risk estimate. The listed deaths cannot be attributed to treatment from the registry information. Overall, the registry record describes the question and broad design, but does not report enough outcome or analysis information to support a conclusion about biomarker prediction or treatment effect.
13. Why This Trial Matters Statistically
This study raises a statistical question that is important for biomarker research: whether a measurement taken before treatment can help anticipate a later response. Establishing such a relationship requires more than describing the treatment and counting outcomes. The biomarker must be defined, the response rule must be clear, and the analysis must show how response varies with biomarker status, with uncertainty reported.
The record also illustrates why endpoint definition matters. RECIST 1.1 and PET Response Criteria are both named in the primary outcome title, while the description specifically refers to RECIST 1.1. If assessment methods differ, the way they classify response can affect the endpoint and the resulting estimate. Clear reporting would allow readers to understand whether the methods were compared and how disagreements were addressed; those details are not reported in the registry record.
Design is equally important to the claim being considered. A single-group study can describe outcomes and explore biomarker-response patterns among treated participants. It does not include a separate treatment arm in the registry record, so it cannot directly determine whether biomarker status identifies a difference in benefit between treatment options. This distinction separates a potentially useful association from evidence that a marker predicts treatment-specific benefit.
The record’s lack of posted primary analyses means that readers cannot assess the estimate, precision, or robustness of any biomarker finding. This is not a conclusion that the study did or did not find an association; it means the registry information does not report that result. The study is therefore statistically notable for its intended biomarker question and for the limits imposed by the single-group design and incomplete outcome reporting.
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 in interpreting the registry record is that it does not report the primary outcome result or any analysis. Although the study lists one outcome measure, there is no response count, biomarker association estimate, confidence interval, or p-value. The strength and precision of the intended finding therefore cannot be assessed.
The primary outcome wording is not fully resolved. The title references RECIST 1.1 versus PET Response Criteria, while the description names RECIST 1.1. The registry does not state the response threshold, explain how the criteria were compared or combined, or identify how discordant classifications were handled. The relation between the response endpoint and homologous recombination repair status is also not specified in the outcome description.
The single-group design has no separate treatment comparator in the registry record. It can support description of outcomes among participants receiving the regimen, but it limits conclusions about comparative treatment effects and about whether a biomarker predicts treatment-specific benefit. The record does not report a planned analysis that addresses this distinction.
Participant flow and analysis details are also unavailable. The record gives enrollment as 49 and describes the outcome population as participants who have concluded treatment and are no longer on study, but does not report how many had an assessable response, whether any data were missing, or how missing assessments were handled. Eligibility criteria, biomarker classification rules, assessment timing beyond the stated 2 years from baseline, and the statistical plan are not reported in the registry record.
The safety information is limited to group counts, listed terms, percentages for selected serious events, and a death count. The record does not give attribution, timing, or sufficient detail to interpret these entries as causal or comparative estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy — NCT02422498.
- Registry record last updated 2026-03-24; status last verified 2026-03.
- Results first posted 2024-02-09.
- 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
NCT02422498 is a phase II, single-group study sponsored by Memorial Sloan Kettering Cancer Center. It concerns locally recurrent or metastatic triple-negative breast cancer and concurrent cisplatin and radiation therapy, with a pre-treatment biopsy used in the study’s biomarker question. The interventions listed are cisplatin, external beam radiation therapy, and biopsy of the target tumor.
The registry lists enrollment as 49, no masking, and allocation as not applicable. The study started on 2015-04-14, has a primary completion date of 2022-12-19, and is active, not recruiting. The primary outcome concerns response at 2 years from baseline and names RECIST 1.1 and PET Response Criteria.
The record lists one outcome measure and no analyses. It does not report the primary response result, the biomarker analysis, or the statistical analysis plan. Consequently, the registry information describes the intended question and broad design but does not establish whether pre-treatment biopsy findings predicted response.