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 Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (NCT03556358), a randomized phase 3 study. The primary outcome is Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03556358 |
| Phase | Phase 3 |
| Condition | Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 809 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tanvex BioPharma USA, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns subjects with HER2-positive early breast cancer. The listed conditions include breast cancer, breast neoplasms, HER2-positive breast cancer, Stage II breast cancer, and Stage IIIA breast cancer. The primary endpoint is described for the Per Protocol Population: subjects who received at least one dose of TX05 or Herceptin and had no major protocol deviations that impact the efficacy endpoints. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
The experimental treatment was TX05 (trastuzumab), given with chemotherapy. The regimen began with epirubicin and cyclophosphamide, followed by TX05 and paclitaxel. The arm description specifies an intravenous TX05 loading dose followed by subsequent doses. The comparison is therefore between the trastuzumab products within the treatment regimens described, not between trastuzumab treatment and no trastuzumab treatment.
Comparator
The comparator was Herceptin®, also given with epirubicin, cyclophosphamide, and paclitaxel in the sequence described in the registry record. Participants were randomized to the TX05 or Herceptin® arm, and the study is described as double-blind. The registry record does not describe how blinding was maintained or whether any participants, investigators, or assessors were unblinded during the trial.
Primary question
The main efficacy question was whether the proportion achieving pathologic complete response differed between the treatment arms. The endpoint was determined by central review after neoadjuvant systemic therapy and was defined by the absence of residual invasive cancer in the resected breast specimen and sampled lymph nodes. Although the endpoint definition is reported, the registry record does not report arm-specific pCR results or a comparative effect estimate in the information available for this analysis.
3. Trial Design
This was a randomized, double-blind, parallel-group Phase III trial comparing TX05 (trastuzumab) with Herceptin® in subjects with HER2-positive early breast cancer. The record describes the study as multicenter. Enrollment was 809, and the registry status is completed. The recorded study start was 2018-06-28, with primary completion on 2020-11-27.
Both arms received epirubicin and cyclophosphamide first, followed by a trastuzumab product with paclitaxel. In the TX05 arm, the description specifies intravenous epirubicin, 75 mg/m^2, and cyclophosphamide, 600 mg/m2, every 3 weeks for 4 cycles, followed by intravenous TX05 at an 8 mg/kg loading dose and then 6 mg/kg, with paclitaxel 175 mg/m2 every 3 weeks for 4 cycles. The Herceptin® arm description follows the same sequence and doses, substituting Herceptin® for TX05.
Randomization supports a comparative design by assigning participants to treatment groups, while double masking is intended to limit knowledge of assignment during the trial. These design features do not, by themselves, establish that the groups were comparable in every respect or that bias was absent. The registry record does not report the randomization method, allocation concealment details, or the practical masking procedures.
The primary endpoint was the proportion achieving pathologic complete response, assessed 3-7 weeks following the last dose of study treatment. Objective Response Rate (ORR) is listed as a secondary outcome. A sample-size justification, details of planned interim analyses, and a full statistical analysis plan 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.
Before assignment: Of the 806 subjects who initiated protocol treatment, 794 subjects initiated Cycle 5 (when trastuzumab was added); of these 394 subjects received TX05 and 400 subjects received Herceptin.
Overall Study
| Stage | TX05 (Trastuzumab) | Herceptin® |
|---|---|---|
| STARTED | 404 | 405 |
| Subjects Treated | 401 | 405 |
| Subjects Receiving TX05 or Herceptin | 394 | 400 |
| COMPLETED | 393 | 393 |
| NOT COMPLETED | 11 | 12 |
Reasons for not completing this period:
| Reason | TX05 (Trastuzumab) | Herceptin® |
|---|---|---|
| Subjects Randomized that did not Treat | 3 | 0 |
| Subjects who Randomized and Treated but Drop prior to Cycle 5 | 7 | 5 |
| Discontinued Treatment after Cycle 5 due to Adverse Event | 0 | 1 |
| Discontinued Treatment after Cycle 5 due to Death | 0 | 1 |
| Discontinued Treatment after Cycle 5 due to Consent Withdrawn | 0 | 2 |
| Discontinued Treatment after Cycle 5 due to COVID-19 | 0 | 1 |
| Discontinued Treatment after Cycle 5 due to Other (Subject Decision) | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol Population \[includes all subjects who received at least one dose of study drug (TX05 or Herceptin) and had no major protocol deviations that impact the efficacy endpoints\].
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: Safety population/The modified intent-to-treat (mITT) population includes all subjects who are randomized into the study and receive at least 1 dose of TX05 or Herceptin.
| Characteristic | Unit | TX05 (Trastuzumab) | Herceptin® | Total |
|---|---|---|---|---|
| Participants analysed | 394 | 400 | 794 | |
| Age, Continuous | years | 54.2 (SD 11.80) | 53.4 (SD 10.83) | 53.8 (SD 11.32) |
| Sex: Female, Male: Female | Participants | 394 | 400 | 794 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 69 | 71 | 140 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 325 | 328 | 653 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 15 | 14 | 29 |
| Race (NIH/OMB): Asian | Participants | 64 | 72 | 136 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 292 | 286 | 578 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 23 | 27 | 50 |
| Hormone Receptor Status: Positive | Participants | 253 | 254 | 507 |
| Hormone Receptor Status: Negative | Participants | 141 | 146 | 287 |
| ECOG: Grade 0 | Participants | 316 | 305 | 621 |
| ECOG: Grade 1 | Participants | 78 | 95 | 173 |
| Tumor Stage: IIA | Participants | 142 | 141 | 283 |
| Tumor Stage: IIB | Participants | 169 | 173 | 342 |
| Tumor Stage: IIIA | Participants | 83 | 86 | 169 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR), measured over 3-7 weeks following last dose of study treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the proportion of subjects in each treatment arm who achieve pathologic complete response (pCR). The registry defines pCR as no residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy, with the classification ypT0/Tis ypN0. Assessment was by central review, and the stated timeframe was 3-7 weeks following the last dose of study treatment.
In general, a pathologic response endpoint uses examination of tissue after preoperative treatment to assess whether invasive cancer remains in the sampled surgical material. A complete-response endpoint is a binary outcome: each assessed participant either meets the stated definition or does not. Comparing the proportions in randomized arms can provide evidence about differences in response under the studied regimens. Central review can help standardize endpoint classification, though the record does not report review procedures beyond central review or describe how disagreements were handled.
The endpoint definition and timing are reported, but the registry record does not report the number or proportion of participants achieving pCR in either arm in the information available for this analysis. It also does not report a comparative estimate or confidence interval for this primary outcome. The endpoint’s meaning can therefore be described, but the size and precision of the observed treatment contrast cannot be assessed from the posted primary outcome information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the comparison’s design and the definition of its primary efficacy endpoint, but the primary pCR result is not reported in the information available for this analysis. The record indicates that pCR was assessed by central review and defines the pathology criteria. It does not give the number of participants with pCR in either arm, the corresponding proportions, an effect estimate, or a confidence interval. Consequently, no conclusion about the direction, magnitude, or precision of the primary comparison can be drawn from the available result information.
The posted safety figures are descriptive counts. For serious adverse events, the TX05 group has 11 affected participants among 394 at risk, and the Herceptin® group has 9 among 400 at risk. For other adverse events, the counts are 246 among 394 and 250 among 400, respectively. The death counts are 0 and 1, respectively. These counts should be read as reported rather than as adjusted comparisons. They do not identify whether events were caused by treatment, whether participants experienced more than one event, or whether the deaths were related to an adverse event; those details are not reported in the registry record.
The listed serious-event terms include Drug-induced liver injury and Urinary Tract Infection at 0.5% each, Acute Kidney Injury at 0.5%, Febrile Neutropenia at 0.3%, Intervertebral Disc Protrusion at 0.3%, and Diabetic Metabolic Decompensation at 0.3%. These are registry-listed percentages; the record excerpt does not give the associated event counts or additional context for each term.
In general, an estimate of a treatment difference needs both an effect measure and information about its uncertainty. A confidence interval communicates a range of values compatible with the data under the analysis assumptions; its width reflects precision, not clinical importance by itself. Because the primary effect estimate and interval are not reported, the degree of precision for the pCR comparison is not assessable. The record also does not report a statistical test or a p-value for that primary comparison.
The registry lists ORR as a secondary outcome, but its numerical results are not reported in the record information available for this analysis. The record identifies a Per Protocol Population for the primary endpoint; it does not report how that population was handled in relation to missing endpoint assessments, nor does it provide an intention-to-treat result in the information available. Thus, the available material supports an account of the planned comparison and certain safety counts, but not a quantitative efficacy conclusion.
9. Statistical Methods Explained
The registry describes a randomized, double-blind, parallel-group comparison of TX05 with Herceptin®. The primary efficacy measure is a binary response: participants either meet the stated pCR criteria or do not. The intended comparison is between the proportions achieving pCR in the two treatment arms. However, arm-level pCR counts and proportions are not reported in the registry record in the information available for this analysis, so no primary effect estimate or interval can be interpreted.
What does a binary endpoint mean?
General statistical explanation: a binary endpoint records whether an event or condition is present for each participant. For pCR, the relevant classification is whether the central pathology review meets the registry’s definition. A comparison of response proportions is a comparison of the share of assessed participants classified as responders in each arm. The result depends on the endpoint definition, the population included in the analysis, and how missing or unevaluable assessments are treated. The record defines pCR and names the Per Protocol Population, but it does not report the primary endpoint counts or the handling of missing assessments.
Why does randomization matter?
General statistical explanation: random assignment is used to reduce systematic differences between treatment groups at the start of a trial. It helps make a between-group outcome contrast interpretable as a treatment comparison, subject to adherence, outcome measurement, missing data, and other sources of bias. Randomization does not guarantee that every baseline characteristic will be identical across groups. The registry identifies the trial as randomized but does not report the sequence-generation procedure, allocation concealment, or baseline characteristics in the information available for this analysis.
What does double-blind mean for interpretation?
General statistical explanation: masking can reduce the influence of treatment knowledge on participant reporting, clinical care, and outcome assessment. Its value depends on who was masked and whether masking was maintained. The record labels the trial double-blind, but does not describe the masked roles or procedures. The pCR endpoint was assessed by central review, which identifies the review arrangement, but further information about reviewer masking and adjudication is not reported in the registry record.
How should confidence intervals and tests be understood?
General statistical explanation: a confidence interval describes uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater statistical precision than a wider interval, but precision alone does not establish that an effect is important. A hypothesis test evaluates the compatibility of observed data with a specified null hypothesis under a chosen analysis. Neither a confidence interval nor a p-value is reported for the primary pCR comparison in the information. The statistical test, model, and covariate adjustment plan are not reported in the registry record.
What is the role of the sample-size illustrations?
The sample-size assumptions state that planning illustrations use the observed effect, two-sided significance level 0.05, equal allocation between arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence about the trial’s actual design rationale and not observed power. An illustration based on the observed effect asks how many participants per arm might be needed under those assumptions to target a chosen power and effect fraction. It does not show that the original study was designed with those assumptions, nor does it establish the probability that the trial’s hypothesis was true. The sample-size justification and the trial’s own planning calculations are not reported in the registry record.
General statistical explanation: planning calculations depend on the expected event rate, target effect, allocation, significance level, and desired power, among other choices. If the true effect is smaller than the observed effect used for an illustration, the required sample size may be larger; if it is larger, it may be smaller, all else equal. Such calculations are sensitive to the assumptions and should not be confused with observed treatment effects. The registry’s stated assumptions clarify the basis of the illustrations, but they do not fill in the missing primary endpoint results or establish the trial’s prospective planning choices.
What can the safety counts establish?
The serious and other adverse-event figures are reported as participants affected and participants at risk. They can describe the number recorded in each group, but the available information does not provide an adjusted risk comparison, uncertainty interval, event-level exposure time, or causal attribution. General statistical explanation: adverse-event data can involve participants with multiple events, so a participant count and an event count are not interchangeable. A comparison may also require attention to follow-up time and event definitions. The registry record does not provide enough detail to assess those issues or to calculate a comparative safety effect.
Overall, the statistical methods that can be identified are the randomized parallel-group design, the binary pCR outcome, the named Per Protocol Population, and the stated assumptions for planning illustrations. A specific primary analysis model, missing-data procedure, multiplicity adjustment, interim analysis approach, and complete analysis plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies pCR as the primary outcome and Objective Response Rate (ORR) as a secondary outcome. It does not report a multiplicity strategy in the information available for this analysis. Multiplicity is the issue that arises when several outcomes, comparisons, or analyses are examined: without an appropriate plan, the chance of at least one nominally positive finding can increase. General statistical explanation: methods such as hierarchical testing or adjusted significance thresholds can control error rates, but the appropriate approach depends on the prespecified objectives and analysis plan. The registry record does not report whether any such method was planned or used.
Missing-data handling for the primary endpoint is also not reported in the registry record. The record defines the Per Protocol Population as subjects who received at least one dose of study drug and had no major protocol deviations that impact the efficacy endpoints. It does not state how participants without a usable pathology assessment were treated, whether any values were imputed, or whether sensitivity analyses were conducted. These details matter because excluding participants or making assumptions about missing outcomes can affect the estimated response proportion.
The available information does not report an intention-to-treat analysis population or explain whether additional populations were analyzed. It also does not report protocol-deviation counts or the criteria for applying them beyond the population description. The per-protocol definition should therefore be understood as the population named for the primary endpoint, not as evidence that all randomized participants contributed to that analysis.
In general, a transparent interpretation of a trial requires knowing which outcomes and analyses were prespecified, how missing assessments were handled, and which analysis population was used. Those details, along with a full statistical analysis plan and any interim-analysis procedures, are not reported in the registry record.
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 |
|---|---|---|---|
| TX05 (Trastuzumab) | 11 | 394 | 2.8% |
| Herceptin® | 9 | 400 | 2.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TX05 (Trastuzumab) | 0 of 394 |
| Herceptin® | 1 of 400 |
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 |
|---|---|
| TX05 (Trastuzumab) | 246 of 394 |
| Herceptin® | 250 of 400 |
Most frequent serious adverse event terms
| Event term | Organ system | TX05 (Trastuzumab) | Herceptin® |
|---|---|---|---|
| Drug-induced liver injury | Hepatobiliary disorders | 2 of 394 | 0 of 400 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 1 of 394 | 1 of 400 |
| Acute Kidney Injury | Renal and urinary disorders | 0 of 394 | 2 of 400 |
| Pneumonia | Infections and infestations | 1 of 394 | 1 of 400 |
| Urinary Tract Infection | Infections and infestations | 2 of 394 | 0 of 400 |
| Neutrophil Count Decreased | Investigations | 1 of 394 | 1 of 400 |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | 1 of 394 | 0 of 400 |
| Diabetic Metabolic Decompensation | Metabolism and nutrition disorders | 1 of 394 | 0 of 400 |
| Vaginal Hemorrhage | Reproductive system and breast disorders | 1 of 394 | 0 of 400 |
| Gastrointestinal Inflammation | Gastrointestinal disorders | 0 of 394 | 1 of 400 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TX05 (Trastuzumab) | Herceptin® |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 50 of 394 | 42 of 400 |
| Myalgia | Musculoskeletal and connective tissue disorders | 45 of 394 | 39 of 400 |
| Asthenia | General disorders | 30 of 394 | 40 of 400 |
| Peripheral Sensory Neuropathy | Nervous system disorders | 33 of 394 | 30 of 400 |
| Nausea | Gastrointestinal disorders | 27 of 394 | 31 of 400 |
| Alanine Aminotransferase Increased | Investigations | 27 of 394 | 26 of 400 |
| Anemia | Blood and lymphatic system disorders | 26 of 394 | 25 of 400 |
| Neuropathy Peripheral | Nervous system disorders | 16 of 394 | 33 of 400 |
| Aspartate Aminotransferase Increased | Investigations | 19 of 394 | 12 of 400 |
Serious events with the highest arm-level rate: drug-induced liver injury (0.5%), urinary tract infection (0.5%), acute kidney injury (0.5%), febrile neutropenia (0.3%), intervertebral disc protrusion (0.3%).
The safety figures distinguish serious adverse events from other adverse events. In the TX05 group, 11 participants had a serious adverse event among 394 at risk; in the Herceptin® group, 9 had a serious adverse event among 400 at risk. The figures for other adverse events are 246 among 394 and 250 among 400, respectively. The reported death counts are 0 in the TX05 group and 1 in the Herceptin® group.
These are descriptive registry counts, not adjusted estimates of comparative risk. The record does not report whether an event was judged related to treatment, the duration of exposure or follow-up for these counts, or whether the reported death was attributed to an adverse event. A count of participants affected also does not indicate the total number of events if a participant experienced more than one event.
The registry lists serious-event terms with percentages: Drug-induced liver injury, 0.5%; Urinary Tract Infection, 0.5%; Acute Kidney Injury, 0.5%; Febrile Neutropenia, 0.3%; Intervertebral Disc Protrusion, 0.3%; and Diabetic Metabolic Decompensation, 0.3%. The record does not report the arm-specific breakdown or event counts for these terms in the information available for this analysis. The figures describe what was recorded; they do not by themselves establish causation or support a definitive comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The trial was designed to compare TX05 (trastuzumab) with Herceptin® within chemotherapy regimens for HER2-positive early breast cancer. Its primary endpoint, pCR, has a defined pathology-based meaning and a stated assessment window. The record also identifies the endpoint population and gives certain safety counts. These details clarify what the study set out to assess and what types of observations were recorded.
However, the primary pCR results are not reported in the registry record in the information available for this analysis. Without arm-specific response counts or proportions, an effect estimate, or a confidence interval, the magnitude, direction, and precision of the primary comparison cannot be described. The definition of an outcome is not a result, and the trial’s completed status does not supply the missing comparative estimate.
The safety counts offer descriptive information about recorded adverse events and deaths in each group. They do not establish that an event was caused by treatment, and they do not provide an adjusted or uncertainty-based comparison. The listed serious-event terms and percentages add detail about reported event categories, but the record does not include their arm-specific counts or further context in the information available for this analysis.
General statistical explanation: a trial result is interpreted through its estimated effect, uncertainty, analysis population, outcome definitions, and design assumptions. A confidence interval helps distinguish a precise estimate from one with substantial uncertainty; a p-value, where reported, addresses compatibility with a specified null hypothesis rather than the clinical importance of a result. Neither the primary interval nor a p-value is reported. The registry record also does not report the full analysis plan, missing-data approach, or multiplicity handling.
Accordingly, the available information supports describing the randomized comparison, endpoint definition, treatment sequences, and posted safety figures. It does not support a conclusion that one treatment had a higher or lower pCR rate, or a definitive claim about comparative safety. Those judgments require outcome results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized, double-blind, parallel-group Phase III comparison of two trastuzumab products within otherwise similarly described chemotherapy regimens. Randomization and masking are relevant design features for comparative research: in general, randomization aims to limit systematic baseline differences, and masking can reduce the influence of treatment knowledge on care and assessment. The registry identifies these features, while procedural details are not reported in the available information.
The primary endpoint is a clinically interpretable binary pathology outcome rather than a subjective description alone. Its definition specifies the resected breast specimen and sampled lymph nodes, and central review is identified. Consistent endpoint definitions are important for comparing arms, but interpretation also depends on who was assessed, how missing evaluations were handled, and what analysis was prespecified. Those details are not reported in the registry record.
The case also illustrates why a trial’s design information and outcome results need to be read separately. The record describes the question, treatment regimens, endpoint, and some adverse-event counts, but the primary pCR comparison is not reported in the information available for this analysis. A completed trial designation cannot substitute for arm-specific estimates or their uncertainty. Without those, the central efficacy question remains quantitatively unresolved in the registry information.
The posted safety counts are useful descriptions, but counts alone cannot establish comparative safety or causation. A fuller statistical interpretation would require clear event definitions, the analysis population, follow-up context, and uncertainty estimates. Likewise, a multiplicity strategy and missing-data approach would help readers understand how the primary and secondary outcomes were analyzed. The absence of these details limits what can be inferred, rather than changing the meaning of the reported design features.
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 primary limitation is that the registry record does not report arm-specific pCR results in the information available for this analysis. The record provides the endpoint definition and timeframe, but not the response counts, proportions, comparative estimate, confidence interval, or test result. The efficacy question therefore cannot be answered quantitatively from these results.
The analysis population is described as Per Protocol, including subjects who received at least one dose of TX05 or Herceptin and had no major protocol deviations that impact efficacy endpoints. The record does not report how many participants were included in that population, how missing or unevaluable pathology assessments were handled, or whether an intention-to-treat analysis was also conducted. This makes it difficult to assess the impact of exclusions or missing data.
The registry identifies ORR as a secondary outcome, but its numerical results are not reported in the information available for this analysis. Multiplicity procedures, the statistical model, covariate adjustment, and any interim analyses are not reported in the registry record. The sample-size assumptions for planning illustrations do not establish the study’s original design rationale; a sample-size justification is not reported.
The safety information is also limited to descriptive counts and listed serious-event terms and percentages. The record does not provide causal attribution, exposure-adjusted comparisons, uncertainty intervals, or full arm-specific details for the listed terms in the information available. Randomized and double-blind design labels are reported, but methods for allocation concealment, masking, and outcome adjudication are not detailed. These gaps restrict assessment of the strength and scope of conclusions that can be drawn from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer — NCT03556358.
- Registry record last updated 2022-01-14; status last verified 2022-01.
- Results first posted 2022-01-14.
- 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
NCT03556358 is a completed, randomized, double-blind, parallel-group Phase III study comparing TX05 (trastuzumab) with Herceptin® in HER2-positive early breast cancer. Enrollment was 809. Both arms received epirubicin and cyclophosphamide followed by a trastuzumab product and paclitaxel. The primary endpoint was pathologic complete response, assessed by central review 3-7 weeks following the last dose of study treatment. Objective Response Rate was listed as a secondary outcome.
The registry record describes the pCR definition and names the Per Protocol Population, but the primary arm-specific pCR results and comparative estimate are not reported in the information available for this analysis. Serious and other adverse-event counts and death counts are reported descriptively. The registry record does not report a complete statistical analysis plan, missing-data method, multiplicity strategy, or sample-size justification.