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 Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (NCT02827877), a na phase 2 study. The primary outcome is Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02827877 |
| Phase | Phase 2 |
| Condition | HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | City of Hope Medical Center |
| Results posted | Yes |
2. Clinical Question
The study concerns patients with HER2-positive breast cancer that has spread to nearby tissue or lymph nodes. The registry lists stage IIIA, stage IIIB, and stage IIIC breast cancer among the conditions. The record does not report further population details such as age limits or other eligibility criteria.
Population
Patients with locally advanced HER2-positive breast cancer, including the listed stage IIIA, IIIB, and IIIC conditions. The primary endpoint refers to protocol patients.
Intervention
Copper Cu64-DOTA-trastuzumab PET imaging and laboratory biomarker analysis are used in the setting of neoadjuvant trastuzumab and pertuzumab treatment before surgery. The registry describes PET scans at 18-24 and 42-48 hours after the imaging dose.
Comparator
No separate comparator group is described. This is a single-group study, with allocation listed as not applicable and no masking.
Primary question
Does PET imaging and molecular-marker information help predict complete pathologic response, assessed at definitive surgery? Complete pathologic response is defined as no residual invasive cancer in the breast or regional lymph nodes.
The question is about prediction: whether imaging or biomarker measurements correspond to the later surgical assessment of residual invasive disease. It is not a randomized comparison of treatment strategies. The registry record does not report a response count, a relationship between imaging or markers and surgical findings, or measures of predictive accuracy. Consequently, the stated study objective can be described, but the posted record does not establish how well the proposed predictors performed.
3. Trial Design
This is a phase II, single-group study sponsored by City of Hope Medical Center. The registry lists enrollment of 18 participants. Allocation is recorded as not applicable, masking as none, and the study model as single group. There is therefore no separate randomized control group in the design described by the registry. The record is marked active, not recruiting.
The study evaluates copper Cu64-DOTA-trastuzumab PET imaging and molecular markers in the setting of neoadjuvant treatment with trastuzumab and pertuzumab, followed by surgery. The intervention list also includes PET, laboratory biomarker analysis, and conventional surgery. The arm description states that trastuzumab is given immediately before the copper Cu64-DOTA-trastuzumab imaging agent on day 0, with PET scans at 18-24 and 42-48 hours. Further treatment-schedule details are not reported in the registry record.
The registered start date is 2018-02-14, and the primary completion date is 2020-07-02. These are registry dates; they do not supply an endpoint result or indicate that a result analysis has been posted. The primary endpoint is assessed at definitive surgery, with a timeframe of up to 1 year.
A single-group design can describe outcomes in the enrolled group and can examine whether measured features are associated with a later outcome if suitable data and analysis are available. It cannot, by itself, provide a randomized comparison between treatment groups. The registry record does not report a statistical analysis plan, a sample-size justification, or how the imaging and biomarker measures were to be combined or evaluated. Such details should not be inferred from the phase designation or the study objective.
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 | Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) |
|---|---|
| STARTED | 18 |
| COMPLETED | 17 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) |
|---|---|
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: protocol patients
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 | Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) |
|---|---|---|
| Participants analysed | 18 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 18 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 54.9 (30.1 to 61.2) |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 0 |
| Race/Ethnicity, Customized: Race/Ethnicity – Asian; Non-Hispanic or Latino | Participants | 4 |
| Race/Ethnicity, Customized: Race/Ethnicity – Black; Non-Hispanic or Latino | Participants | 2 |
| Race/Ethnicity, Customized: Race/Ethnicity – Caucasian; Hispanic or Latino | Participants | 8 |
| Race/Ethnicity, Customized: Race/Ethnicity – Caucasian; Non-Hispanic or Latino | Participants | 3 |
| Race/Ethnicity, Customized: Race/Ethnicity – Not Disclosed; Hispanic or Latino | Participants | 1 |
| Region of Enrollment: United States | Participants | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy)., measured over Up to 1 year.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy).” It is a participant-count outcome, with assessment at definitive surgery and a timeframe of up to 1 year. The registry defines complete pathologic response as no evidence of residual invasive cancer in either the breast or regional lymph nodes.
This endpoint uses the surgical specimen to assess residual invasive disease after neoadjuvant treatment. It therefore measures response at the tissue level rather than relying only on imaging or a clinical examination. The endpoint’s definition is specific: it concerns invasive cancer in the breast and regional lymph nodes. It should not be broadened to mean that every possible sign of cancer or every non-invasive finding is absent.
For the study’s prediction question, the surgical assessment serves as the outcome that PET and molecular-marker measurements are intended to predict. Evaluating prediction would require linking those measurements to each participant’s endpoint classification and reporting an appropriate analysis. The registry record does not report the number of participants with complete pathologic response, the number without it, or a predictive-performance analysis. The endpoint definition is available, but the posted record does not show the observed response result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically interpretable binary endpoint: whether complete pathologic response is present at surgery under the stated definition. However, a definition is not an outcome result. No count of participants with complete pathologic response, no count without it, and no estimate of the response proportion are reported in the registry record. There is therefore no observed primary-effect estimate in the posted information to interpret.
The record describes the study’s aim as using PET imaging and molecular markers to predict response to neoadjuvant trastuzumab and pertuzumab. Prediction requires more than documenting a later response. It requires evidence connecting the predictor measurements to the endpoint, along with an analysis that communicates how reliably the measurements distinguish or estimate outcomes. No such association, prediction metric, uncertainty interval, or statistical test is reported in the registry record. The study objective alone does not establish that the imaging or markers predicted response.
The single-group design also shapes interpretation. There is no separate control arm against which to compare response, imaging, or safety. Findings from a single group could describe that group or support an association analysis, but they would not provide a randomized estimate of a difference between treatment strategies. The posted record does not include a treatment-effect comparison, and none should be inferred.
Enrollment is listed as 18, but this is not the same as a reported endpoint denominator. The number who reached surgery, had an evaluable pathology assessment, or contributed to any predictor analysis is not reported in the registry record. Without those denominators and outcome counts, the precision of any response estimate cannot be assessed. No confidence interval or p-value for the primary endpoint is reported.
The registry lists two outcome measures, but details for the other outcome measure are not reported in the registry record. It lists zero analyses. That means the posted record does not provide an analysis result to evaluate; it does not establish what analyses may or may not have been conducted outside the registry. Overall, the record supports a description of the research question, design, and endpoint definition, but not a conclusion about observed response or predictor performance.
9. Statistical Methods Explained
The primary endpoint is binary: each participant’s surgical assessment is classified according to whether the stated definition of complete pathologic response is met. For a binary endpoint, a basic descriptive result would report the number meeting the definition and the number assessed. A proportion could then describe the frequency of response in the analyzed group. The registry record does not report these endpoint counts or a denominator, so no such result can be interpreted from the posted information.
In general, an estimate describes the observed data, while a confidence interval describes the range of values reasonably compatible with those data under the statistical method used. A wider interval indicates less precision. With no reported response count, denominator, or interval, the precision of the primary endpoint estimate cannot be evaluated. A p-value would address a specified statistical test and null hypothesis; it is not a measure of the size or clinical importance of an effect. No primary endpoint p-value or hypothesis test is reported in the registry record.
The research objective is predictive, which calls for analysis of the PET or biomarker measurements in relation to the surgical response classification. General approaches could examine whether a measurement differs between participants with and without complete pathologic response, or assess how well a prediction rule classifies outcomes. Those analyses require participant-level predictor and outcome information, a prespecified or clearly described model, and suitable reporting of uncertainty and performance. The registry record does not report the predictor values, model, decision threshold, performance measures, or analysis results. It is therefore not possible to judge predictive accuracy from the stated objective alone.
The record describes PET scans at 18-24 and 42-48 hours after the imaging procedure. If measurements at more than one time or from more than one marker were evaluated, the analysis would need to clarify how those measurements were selected, combined, and interpreted. In general, testing multiple candidate markers or time points can increase the chance of apparently notable findings arising by chance. A prespecified approach or an explicit account of multiplicity helps readers understand how such results should be viewed. The statistical plan and any multiplicity strategy are not reported in the registry record.
The record also contains a sample-size planning illustration described as a calculation from an observed effect, rather than the study’s own design justification. Its stated assumptions are 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 fraction of the observed effect. This hypothetical two-arm planning framework is distinct from the registered single-group study. The registry record does not report its own sample-size justification, and no numerical planning result is available in the information. Such planning illustrations are not observed power and do not establish the probability that the study detected an effect.
General interpretation of binary outcomes also depends on the analysis population. For example, the denominator might consist of all enrolled participants, those who underwent surgery, or those with an evaluable pathology assessment. These groups need not be identical. The registry record does not report which participants were included in a primary analysis, how participants without an endpoint assessment were handled, or whether any sensitivity analyses were performed. Those omissions prevent a full assessment of the endpoint analysis.
The study’s single-group structure matters for the statistical question. Descriptive response rates and predictor-outcome associations may be estimated within one group, but a treatment comparison requires a suitable comparator. Because the record lists no control group, an effect contrasting treatment arms is not available. More broadly, association between an imaging measurement and response would not, on its own, establish that the measurement causes the response or that it will predict outcomes in a different population. These are general distinctions between description, prediction, and causal comparison.
No analysis results are posted in the registry record. Accordingly, there are no reported estimates, uncertainty intervals, test results, or model diagnostics to assess. The statistical methods needed to answer the study’s prediction question are not reported in the registry record; the general methods above explain what such reporting would help readers understand, not what this study actually did.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is defined, but the registry record does not describe a statistical plan for testing it. It does not report a multiplicity strategy for the imaging measurements, molecular markers, or any additional outcomes. If several candidate predictors or measurement time points are explored, the number and selection of analyses can affect how strongly individual findings should be interpreted. A prespecified primary analysis and transparent reporting of other analyses would help distinguish confirmatory from exploratory results. Those details are not reported in the registry record.
The record lists two outcome measures and zero analyses, but does not provide endpoint analysis results. The primary endpoint’s count, analysis denominator, and handling of participants without an evaluable surgical assessment are not reported in the registry record. The approach to missing imaging or biomarker measurements is also not reported. Without this information, readers cannot determine whether the analyzed participants differed from those enrolled or how incomplete measurements might affect a prediction analysis.
Analysis-population definitions are not reported. The registry record does not state whether the primary analysis included all enrolled participants or only those who reached surgery and had an evaluable pathology result. Nor does it describe any alternative populations or sensitivity analyses. These are consequential details for interpreting a participant-count endpoint, particularly when the enrolled count and the number with outcome data may differ.
These are reporting gaps in the registry record, not evidence that a particular method was or was not used outside the record. No assumptions about the study’s protocol, missing-data procedures, or analysis plan can be made from the endpoint definition alone.
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 |
|---|---|---|---|
| Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) | 2 | 18 | 11.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) | 0 of 18 |
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 |
|---|---|
| Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) | 18 of 18 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) |
|---|---|---|
| acute hordeola of the right upper eyelid | Eye disorders | 1 of 18 |
| bacteriemia | Infections and infestations | 1 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) |
|---|---|---|
| 10012727-Diarrhea | Gastrointestinal disorders | 14 of 18 |
| 10028813-Nausea | Gastrointestinal disorders | 14 of 18 |
| 10016256-Fatigue | General disorders and administration site conditions | 13 of 18 |
| 10002272-Anemia | Blood and lymphatic system disorders | 10 of 18 |
| 10020772-Hypertension | Vascular disorders | 8 of 18 |
| 10010774-Constipation | Gastrointestinal disorders | 7 of 18 |
| 10016558-Fever | General disorders and administration site conditions | 6 of 18 |
| 10001760-Alopecia | Skin and subcutaneous tissue disorders | 6 of 18 |
| 10028130-Mucositis oral | Gastrointestinal disorders | 5 of 18 |
| 10001551-Alanine aminotransferase increased | Investigations | 5 of 18 |
Serious events with the highest arm-level rate: acute hordeola of the right upper eyelid (5.6%), bacteriemia (5.6%).
The registry reports safety information for one treatment group, with 18 participants at risk. Two participants are listed as affected by serious adverse events, 18 as affected by other adverse events, and deaths are listed as 0. These are reported counts for the single group, not a comparison with an untreated or alternative-treatment group.
The two serious adverse-event terms listed are acute hordeola of the right upper eyelid and bacteriemia, each reported as 5.6%. These are the registry’s term-level entries. The record does not provide additional context in the information about timing, duration, attribution, or how events were distributed among participants. The term percentages should not be treated as evidence of a comparative risk.
Serious adverse events and other adverse events are separate registry categories. The count of 18 affected by other adverse events does not indicate that all such events were serious, nor does the record establish whether participants experienced more than one event. Counts alone also do not show whether an event was caused by a treatment or procedure. Because there is no comparison group, these safety figures describe what was recorded in this group but do not establish relative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to examine PET imaging and molecular markers as predictors of pathologic response after neoadjuvant trastuzumab and pertuzumab. It defines complete pathologic response using the surgical assessment of invasive cancer in the breast and regional lymph nodes. These details explain the intended question and endpoint, but they are not evidence that the proposed predictors succeeded or failed.
The primary response count and the analysis linking imaging or biomarkers to surgical outcome are not reported in the registry record. There is no reported estimate of response frequency, predictive accuracy, uncertainty, or statistical significance. It is therefore not possible to judge how common complete pathologic response was in the enrolled group, how precise any estimate might be, or whether PET or molecular markers were associated with the endpoint.
The single-group design also limits the claims that could be supported by a simple outcome description. Without a separate comparator, the record cannot provide a randomized contrast between treatment strategies. Even if a predictor-outcome association were reported, an association would not by itself establish causation or demonstrate that the same prediction would apply to other patient groups or settings.
The safety counts describe events recorded in the study group, including two participants affected by serious adverse events and zero deaths. They do not provide a comparative safety estimate. The record does not report the detail needed to assess event timing, attribution, or differences from another group.
In short, the posted information supports a careful account of the design, purpose, endpoint definition, and listed safety counts. It does not support a conclusion about treatment benefit, the success of PET-based prediction, or comparative safety. Missing results should not be interpreted as evidence for either a positive or a negative finding.
13. Why This Trial Matters Statistically
This study poses a prediction question rather than a simple treatment-versus-control question. It asks whether imaging with copper Cu64-DOTA-trastuzumab and molecular markers can anticipate a later surgical pathology outcome. Statistically, that requires a clear connection between measurements taken during the treatment course and a well-defined endpoint assessed at surgery.
The endpoint definition is important because it identifies what counts as complete pathologic response: no residual invasive cancer in the breast or regional lymph nodes. A precise definition makes outcome classification more interpretable and helps distinguish the intended endpoint from broader ideas of response. The registry also states that assessment occurs at definitive surgery, with a timeframe of up to 1 year.
The study’s PET schedule includes scans at 18-24 and 42-48 hours. Multiple measurements can raise questions about which time point or marker is most informative, how candidate predictors are handled, and whether a prediction rule is evaluated in the same participants used to develop it. The statistical plan and analysis results are not reported in the registry record, so those questions remain unresolved in the posted information.
The design is single group, with 18 participants enrolled and no comparator arm. That structure may allow descriptions or within-group associations, but it does not yield a randomized treatment contrast. For readers, this distinction prevents a predictor study from being mistaken for a comparative test of treatment effectiveness.
The study is statistically relevant because it brings together an imaging measurement, molecular markers, and a pathology-based outcome. Yet its scientific value cannot be judged from the aim alone. Reporting the endpoint counts, participant denominators, predictor-outcome analyses, uncertainty, and handling of missing data would be needed to assess what the study found and how dependable those findings are.
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 immediate limitation of the posted record is that it defines the primary endpoint without reporting its observed result. The count of participants with complete pathologic response, the count without it, and the denominator assessed at surgery are not reported in the registry record. With enrollment listed as 18, the number contributing to the endpoint analysis remains unknown, so endpoint precision cannot be evaluated.
The single-group design has no separate comparator. It can describe outcomes in the study group, but does not support a randomized comparison of treatment strategies. The stated goal is prediction, yet no results connecting PET or biomarker measurements to pathology are reported. The registry record also does not report prediction metrics, uncertainty intervals, or details of a prediction model.
The statistical analysis plan, sample-size justification, and multiplicity approach are not reported in the registry record. Neither are the analysis population, missing-data handling, or sensitivity analyses. Because the objective involves imaging and molecular markers, these details would be important for understanding how candidate predictors were selected and how incomplete measurements were treated.
The safety information is also limited to counts and two serious-event terms with their listed percentages. The record does not provide the context needed to assess event timing, attribution, or a comparison group. The enrollment count and listed safety denominator do not replace an endpoint-specific analysis denominator.
These limitations concern what can be concluded from the registry record. They do not establish that analyses or further details are absent from other study documents; those details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer — NCT02827877.
- Registry record last updated 2026-11-02; status last verified 2026-10.
- Results first posted 2023-03-09.
- 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
NCT02827877 is a phase II, single-group study sponsored by City of Hope Medical Center. It examines copper Cu64-DOTA-trastuzumab PET imaging and molecular markers in relation to response after neoadjuvant trastuzumab and pertuzumab in HER2-positive breast cancer. The registry lists enrollment of 18, no masking, and no separate comparator group.
The primary endpoint is complete pathologic response at definitive surgery, defined as no residual invasive cancer in the breast or regional lymph nodes, with assessment up to 1 year. The record lists two outcome measures and zero analyses. The primary response count and predictive analysis are not reported in the registry record.
Safety entries list 18 participants at risk, two affected by serious adverse events, 18 affected by other adverse events, and zero deaths. Acute hordeola of the right upper eyelid and bacteriemia are each listed as serious adverse-event terms at 5.6%. These figures describe the study group and are not comparative estimates.