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 A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients (NCT00190671), a randomized phase 1, phase 2 study. The primary outcome is Best Tumor Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00190671 |
| Phase | Phase 1, Phase 2 |
| Condition | Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 103 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with locally advanced or metastatic breast cancer. The study included a single-arm phase 1 dose-finding portion followed by a randomized phase 2 portion. The primary outcome population is described as randomized participants.
Intervention
Pemetrexed and cyclophosphamide in combination. The registry describes the phase 1 portion as dose finding to establish the maximum tolerated dose, and identifies the phase 2 arms by pemetrexed doses of 600 mg/m2 and 1800 mg/m2. Detailed administration schedules are not reported in the registry record.
Comparator
The phase 2 arm labels are Pemetrexed 600 mg/m2 and Pemetrexed 1800 mg/m2. The registry identifies the study as randomized and parallel, but does not report the allocation method or provide further details about how the treatment regimens differed beyond the arm labels.
Primary question
The primary outcome is best tumor response, recorded as the number of randomized participants. The registry describes radiological assessment and response confirmation, but does not post an analysis comparing response between the randomized groups. The record therefore does not establish the size or precision of a between-group difference in best response.
In statistical terms, the study’s central phase 2 question concerns tumor response in participants assigned to the two pemetrexed dose groups in a combination regimen. The registry title and summary identify cyclophosphamide as part of the treatment, while the arm descriptions identify the pemetrexed doses. The record does not describe a no-treatment or placebo group, and it does not state that the study was masked. Its stated design is randomized, unmasked, and parallel.
The phase 1 and phase 2 parts address different questions. The phase 1 portion is described as a single-arm dose-finding study intended to establish the maximum tolerated dose. The randomized phase 2 portion is the part relevant to comparing the listed groups. The record does not report how the phase 1 findings informed the phase 2 regimen, nor does it report phase-specific enrollment. Overall enrollment is 103, but the number assigned to each phase or randomized arm is not reported in the registry record.
3. Trial Design
This is a completed phase 1/2 study with randomized allocation and a parallel-group model. The registry describes a single-arm phase 1 dose-finding portion before the randomized phase 2 portion. The phase 1 aim was to establish the maximum tolerated dose of the pemetrexed and cyclophosphamide combination. The phase 2 portion tested the combination in advanced breast cancer and identified its groups by pemetrexed doses of 600 mg/m2 and 1800 mg/m2.
Overall enrollment is 103. The record does not break that total down by phase or arm, and arm-specific enrollment is not reported in the registry record. It lists the study as unmasked. The allocation sequence, concealment procedures, randomization ratio, and operational details of treatment assignment are not reported in the registry record. Although the study is described as randomized, those missing details limit how fully the allocation process can be assessed.
The study began in 2005-06, reached primary completion in 2008-03, and is listed as completed. These dates describe the registry’s study timeline; they do not by themselves establish when individual participants were followed or when all outcomes were measured. The primary outcome timeframe is described as baseline to measured progressive disease. The record does not give a common maximum follow-up duration or a detailed schedule for every secondary outcome.
The intervention list includes pemetrexed and cyclophosphamide, with pemetrexed appearing more than once. The arm descriptions identify two pemetrexed dose groups but contain no additional schedule details. The registry’s brief summary describes the combination as the treatment being tested. The record does not report the cyclophosphamide dose, administration schedule, supportive care, dose-modification rules, or other treatment details needed to reconstruct the regimen fully.
Secondary outcomes include time to progressive disease, progression-free survival, and pharmacokinetic measures: maximum observed concentration, area under the curve, clearance, volume of distribution, and half-life. The record lists eight outcome measures overall, while the named secondary outcomes comprise those categories. It does not post analysis records for the outcomes. Consequently, the design can be described, but treatment comparisons, event definitions beyond the primary outcome description, and outcome-specific results cannot be reconstructed from this record alone.
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: This was a Phase 1/2 study. Phase 1 determined the doses to use in the Phase 2 portion. In this 2-stage Simon's optimal design study, enrollment in the 600 mg/m2 arm was stopped at the end of Stage 1 because of lack of efficacy; ongoing patients were allowed to continue treatment. Secondary efficacy endpoints were evaluated for 1800 mg/m2 arm only.
Overall Study
| Stage | Pemetrexed 600mg/m2 | Pemetrexed 1800mg/m2 |
|---|---|---|
| STARTED | 42 | 61 |
| COMPLETED | 15 | 19 |
| NOT COMPLETED | 27 | 42 |
Reasons for not completing this period:
| Reason | Pemetrexed 600mg/m2 | Pemetrexed 1800mg/m2 |
|---|---|---|
| Satisfactory Response | 4 | 7 |
| Lack of Efficacy | 19 | 24 |
| Death from Study Disease | 1 | 1 |
| Adverse Event | 3 | 2 |
| Clinical Relapse | 0 | 1 |
| Death from Study-Drug Toxicity | 0 | 2 |
| Death from Other Causes | 0 | 2 |
| Protocol Violation | 0 | 1 |
| Withdrawal by Subject | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Number of randomized participants.
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 | Pemetrexed 600mg/m2 | Pemetrexed 1800mg/m2 | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 61 | 103 | |
| Age Continuous | years | 59.0 (35 to 80) | 56.0 (32 to 81) | 58.0 (32 to 81) |
| Sex: Female, Male: Female | Participants | 42 | 61 | 103.0 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0.0 |
| Region of Enrollment: Hungary | participants | 11 | 11 | 22.0 |
| Region of Enrollment: Czech Republic | participants | 2 | 2 | 4.0 |
| Region of Enrollment: Poland | participants | 9 | 11 | 20.0 |
| Region of Enrollment: Romania | participants | 9 | 9 | 18.0 |
| Region of Enrollment: Austria | participants | 3 | 11 | 14.0 |
| Region of Enrollment: Russian Federation | participants | 8 | 17 | 25.0 |
| Estrogen-Receptor Status: Positive | participants | 22 | 27 | 49.0 |
| Estrogen-Receptor Status: Negative | participants | 10 | 21 | 31.0 |
| Estrogen-Receptor Status: Unknown | participants | 7 | 4 | 11.0 |
| Estrogen-Receptor Status: Missing | participants | 3 | 9 | 12.0 |
| Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status: Positive | participants | 4 | 3 | 7.0 |
| Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status: Negative | participants | 11 | 27 | 38.0 |
| Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status: Unknown | participants | 9 | 8 | 17.0 |
| Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status: Not Done | participants | 18 | 23 | 41.0 |
| Pathological Diagnosis: Inflammatory Breast Carcinoma | participant | 7 | 10 | 17.0 |
| Pathological Diagnosis: Adenocarcinoma of the Breast | participant | 17 | 27 | 44.0 |
| Pathological Diagnosis: Other | participant | 18 | 24 | 42.0 |
| Progesterone-Receptor Status: Positive | participants | 19 | 25 | 44.0 |
| Progesterone-Receptor Status: Negative | participants | 13 | 23 | 36.0 |
| Progesterone-Receptor Status: Unknown | participants | 7 | 4 | 11.0 |
| Progesterone-Receptor Status: Missing | participants | 3 | 9 | 12.0 |
| Race/Ethnicity: Caucasian | participants | 42 | 61 | 103.0 |
| World Health Organization Performance Status: 0 - Asymptomatic, fully active | participants | 18 | 40 | 58.0 |
| World Health Organization Performance Status: 1 - Symptomatic, fully ambulatory, light activity | participants | 22 | 18 | 40.0 |
| World Health Organization Performance Status: 2 - Symptomatic, ambulatory, no work activities | participants | 2 | 3 | 5.0 |
| Body Surface Area | square meters | 1.8 (1.4 to 2.1) | 1.7 (1.4 to 2.4) | 1.7 (1.4 to 2.4) |
| Height | centimeters | 160.0 (148 to 176) | 160.0 (143 to 180) | 160.0 (143 to 180) |
| Weight | kilograms | 71.5 (50 to 104) | 70.0 (45 to 120) | 70.0 (45 to 120) |
6. Primary Endpoint
The registry lists the primary outcome as Best Tumor Response, measured over baseline to measured progressive disease.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is best tumor response, recorded as the number of randomized participants. The stated timeframe runs from baseline to measured progressive disease. Tumor response was assessed using radiological imaging, repeated every 6 weeks prior to every other cycle. The registry says that a response was to be confirmed no less than 4 weeks (28 days) after the first evidence of response.
Best response is used to describe the most favorable tumor-response category recorded during the specified assessment period. It is a way to summarize repeated assessments rather than treating every image as an independent outcome. Requiring confirmation can help distinguish an initial finding from a response that persists to a subsequent assessment. This is a general explanation of the endpoint concept; the registry does not report the specific response categories, the rules for assigning them, or how missing or unevaluable assessments were handled.
The endpoint is presented as a count of participants, but the record does not post the category counts or a statistical comparison between randomized groups. It also does not identify a single binary definition of response, such as a responder versus non-responder threshold. The registry record notes that the primary outcome has several categories or time points and is not reduced to one comparison. Therefore, the available description supports explaining how tumor response was assessed, but not estimating a group effect or its uncertainty.
Radiological response is distinct from time-to-event outcomes such as time to progressive disease and progression-free survival, which are listed as secondary outcomes. Those outcomes concern the timing of disease events under their respective definitions, while best response concerns the response category recorded across assessments. Their results and analysis details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes that this completed study combined an initial single-arm dose-finding phase with a randomized phase 2 comparison. The two phase 2 groups are identified by pemetrexed doses of 600 mg/m2 and 1800 mg/m2, and the study description identifies cyclophosphamide as part of the combination. Overall enrollment is 103. The registry does not state how many participants entered the phase 2 comparison or how many were assigned to either arm.
For the primary outcome, the record gives a measurement approach but no posted group results. It describes best tumor response assessed by imaging, with assessments every 6 weeks prior to every other cycle and intended confirmation at least 4 weeks (28 days) after first evidence of response. However, it does not give the numbers of participants in response categories, an estimated contrast between arms, a confidence interval, or a p-value. No conclusion about the direction, magnitude, or precision of a primary-outcome difference can be drawn from the registry record.
The registry lists eight outcome measures and names secondary outcomes related to disease progression and pharmacokinetics. It reports no analysis records. A list of planned or registered outcomes is not equivalent to reported results: outcome names alone do not show what was observed, how many participants contributed, or how uncertainty was quantified. The absence of posted analyses also means the record cannot establish whether all planned outcomes were analyzed or whether any results were omitted.
Safety information is presented as counts of participants with serious and other adverse events in the two pemetrexed dose groups. The serious-event counts are 6 for Pemetrexed 600mg/m2 and 13 for Pemetrexed 1800mg/m2; the other-event counts are 38 and 59, respectively. The number at risk is not reported for either group, so these counts cannot be interpreted as rates or compared as if the groups had equal exposure. The record also does not provide event-level participant denominators or a detailed account of event collection.
The listed serious adverse-event terms and percentages include Anaemia and Dyspnoea at 4.8% each, Leukopenia and Neutropenia at 3.3% each, and Febrile neutropenia and Thrombocytopenia at 2.4% each. The record does not identify the denominator used for these percentages in the information available. They should therefore be read as registry-listed percentages rather than recalculated or treated as arm-specific risks.
The record contains assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such illustrations are not observed results and do not constitute the trial’s design justification. The registry does not report the original sample-size justification, interim analyses, or the statistical plan. Overall, the posted information is sufficient to describe the design and endpoint procedures, but not to estimate comparative efficacy or safety with precision.
9. Statistical Methods Explained
Randomized allocation means assignment to study groups is intended to use a chance-based process. In general, randomization can reduce systematic differences in measured and unmeasured characteristics between groups, but it does not guarantee that groups are identical, especially when group sizes are modest. The registry identifies this study as randomized and parallel. It does not report the sequence-generation method, allocation concealment, or randomization ratio, so the practical safeguards around assignment cannot be assessed from the record.
A parallel design assigns participants to a group that remains the basis for that group’s comparison rather than having each participant receive both regimens in sequence. That is a general description of the design label, not a claim about the details of treatment exposure in this study. The record lists the two phase 2 groups by pemetrexed dose and describes the combination with cyclophosphamide. It does not specify full dosing schedules or whether other treatment features were otherwise identical.
The phase 1 portion is described as single-arm dose finding to establish the maximum tolerated dose. In general, dose-finding research uses observed tolerability and safety information to guide selection of a dose for further study. The registry record does not report the dose-escalation rules, the definition of dose-limiting toxicity, the number treated at each dose, or how the phase 1 findings were used in phase 2. No assumptions about those procedures can be made from the phase 1/2 label alone.
How should the primary outcome be read?
Best tumor response is a categorical outcome based on radiological assessments over time. The registry says imaging was repeated every 6 weeks prior to every other cycle and that a response was to be confirmed no less than 4 weeks (28 days) after initial evidence. In general, confirmation rules aim to avoid treating an isolated assessment as a sustained response. For a categorical endpoint, counts in each response category and the rules for assigning categories are needed to understand the observed distribution. Those category definitions and counts are not reported in the registry record.
The primary outcome’s stated unit is participants, and the population is described as randomized participants. This identifies the intended population for the count but does not tell whether every randomized participant was included in each outcome category, how participants with missing scans were handled, or whether participants who stopped treatment remained in the analysis. Those analysis details are not reported in the registry record. The posted record also does not provide an estimated group contrast, confidence interval, or test result.
What does a confidence interval convey?
In general, a confidence interval expresses the uncertainty around an estimated effect under the statistical model and sampling procedure used. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. An interval is not a guarantee that the true effect lies within its limits, and it does not replace assessment of the endpoint definition, study design, or potential bias. No confidence interval for the primary comparison is reported in the registry record, so the precision of any between-group response difference cannot be evaluated.
What do the planning assumptions mean?
The record describes planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not observed outcomes, and they are not evidence of the study’s actual statistical power. The record does not provide the original sample-size justification or establish that these assumptions were used to design the trial.
For time-to-event outcomes, the planning description uses the Schoenfeld approach and refers to a total number of events. In general, time-to-event methods use information about event occurrence and timing, so the number of observed events can be central to the precision of an estimated comparison. For other outcomes, the planning description refers to participants per arm. These are different planning quantities and should not be conflated. The registry record does not provide the calculation outputs or the values for every planning input, so no sample-size requirement can be inferred from the assumptions alone.
Over-dispersion is a general issue for count data when variability exceeds what a simple model assumes. If present, it can make standard errors from an overly restrictive model too small and confidence intervals too narrow. That concern is relevant in general to count outcomes, but the primary endpoint is described as participant counts across multiple response categories, and no model specification or dispersion assessment is reported. There is no basis in the registry record to claim that over-dispersion was assessed or that a particular count model was used.
How should the adverse-event counts be interpreted?
The record gives serious and other adverse-event counts for the two dose-labeled groups, but does not report the numbers at risk. A count is the number of affected participants, while a rate or proportion requires a denominator. Without the relevant group sizes and exposure information, the counts alone do not establish comparative risk. The registry also does not report whether one participant could contribute to multiple event terms or how repeated events were counted. General statistical interpretation therefore requires restraint: the listed figures describe counts and terms, not a complete comparative safety analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described as having several categories or time points and is not reduced to one comparison. This matters because a study with multiple outcome categories, time points, or comparisons may make several statistical tests. In general, the more tests that are considered, the greater the chance of at least one apparently notable result arising by chance if no adjustment or prespecified testing strategy is used. The registry record does not report a multiplicity strategy, an ordered testing procedure, or which comparisons were designated as primary for statistical testing.
The record lists eight outcome measures, including best tumor response, time to progressive disease, progression-free survival, and pharmacokinetic measures. It does not report analysis records. The fact that outcomes are registered does not establish that each was analyzed, nor does the record describe how any multiple outcomes would be interpreted together. A statistical analysis plan and its timing are not reported in the registry record.
Missing-data handling is also not reported in the registry record. For a radiological outcome assessed repeatedly, relevant details would include how absent assessments, unevaluable scans, or withdrawal before confirmation were handled. The record does not specify whether participants without an evaluable response were placed in a particular category, excluded from a response analysis, or handled using another approach. These possibilities should not be assumed.
The primary outcome population is described as randomized participants, but the record does not provide a fuller analysis-population definition. It does not state whether analyses followed assignment regardless of treatment received, required treatment exposure, or used another set of participants. Nor does it report arm-specific denominators for the primary outcome. As a result, the relationship between the randomized population, the participants with outcome assessments, and the adverse-event denominators cannot be determined from the registry record.
11. What the Result Does, and Does Not, Mean
The record supports a description of a phase 1/2 study of pemetrexed and cyclophosphamide in advanced breast cancer, with a single-arm dose-finding phase followed by randomized phase 2 groups labeled by pemetrexed dose. It also documents the primary outcome’s general assessment approach and lists secondary outcomes and adverse-event information. Those details describe the study’s structure and what it intended to measure.
They do not establish a treatment effect. The registry record does not report the primary response-category counts, a between-group estimate, a confidence interval, or a p-value. It therefore cannot show the magnitude or precision of any response difference between the randomized groups. The absence of an analysis record is not evidence that groups had the same outcomes, nor does it establish that one group had better outcomes.
The adverse-event counts are also incomplete for comparative interpretation because the number at risk is not reported. Counts are not rates, and the record does not supply the denominators needed to interpret them as group-specific proportions. The listed percentages for serious adverse-event terms are registry figures, but the corresponding denominator is not identified in the information available. No causal conclusion about adverse events can be drawn from those entries alone.
In general, statistical evidence depends on more than a study’s design label or a list of outcomes. Interpretation requires outcome definitions, analysis populations, denominators, estimates, measures of uncertainty, and a transparent account of missing data and analysis choices. Several of those elements are not reported in the registry record. Consequently, the registry can inform readers about the planned structure and measurement procedures, but it does not provide enough information to judge the comparative results.
Planning illustrations based on an observed effect are not a substitute for an observed treatment comparison and should not be described as observed power. They indicate how assumptions can be used to explore sample-size requirements in general. The registry does not report the original sample-size rationale or the results needed to evaluate the primary question. Any interpretation should remain limited to the documented design, endpoint procedures, and posted event counts.
12. Why This Trial Matters Statistically
This study illustrates why a registry description and a statistical result are different kinds of information. The record identifies a randomized, parallel phase 2 comparison after a single-arm dose-finding phase, names the two pemetrexed dose groups, and specifies a radiological response-assessment process. Those design details help define the question and the intended measurements even though comparative analyses are not posted.
The structure also raises practical interpretation questions. The phase 1 portion was intended to establish a maximum tolerated dose, while phase 2 compared groups identified by dose. Understanding how dose selection proceeded, whether treatment features were otherwise consistent, and how the phase-specific populations differed would help readers interpret the randomized comparison. These details are not reported in the registry record.
Best response is assessed repeatedly and summarized across response categories, while secondary outcomes include time-to-event and pharmacokinetic measures. These outcomes require different summaries and may have different analysis populations and sources of uncertainty. The registry lists them but does not provide analysis records, making it impossible to connect the outcome definitions to estimated effects or their precision.
The adverse-event entries provide another useful statistical lesson: counts do not become comparable risks without denominators. The group counts and listed percentages can describe what the registry records, but missing at-risk totals limit interpretation. In general, clear reporting of denominators, outcome definitions, missing-data handling, and uncertainty is necessary for readers to distinguish a descriptive count from an estimate of comparative effect.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation of the registry information is the lack of posted primary-outcome analyses. Although the endpoint and assessment schedule are described, response-category counts and between-group estimates are not reported. No confidence interval or p-value is available to describe uncertainty around a comparison. The record therefore does not support a quantitative interpretation of the primary result.
Important design details are also absent. The registry does not report phase-specific or arm-specific enrollment, the randomization ratio, allocation procedures, detailed treatment schedules, or the statistical analysis plan. The arm labels identify pemetrexed doses of 600 mg/m2 and 1800 mg/m2, but the record does not provide enough treatment detail to reconstruct the full regimens. The record also does not explain the phase 1 dose-escalation rules or how its findings informed phase 2.
Outcome interpretation is limited by missing definitions and analysis information. The registry describes radiological assessments and intended response confirmation, but does not list response categories or specify how unevaluable or missing assessments were handled. It does not define the analysis populations beyond describing randomized participants as the primary-outcome population. Multiplicity procedures and interim analyses are not reported in the registry record.
Safety reporting is limited because the numbers at risk are not reported for either dose group. The adverse-event counts therefore cannot be interpreted as rates, and the denominators for the listed serious-event percentages are not identified in the information available. The record does not provide detailed event-collection methods or the handling of participants with different exposure durations.
Finally, the record lists eight outcome measures but no analysis records. This limits assessment of which outcomes were analyzed and how results were selected or interpreted. These are limitations of the available registry information; they do not establish what analyses may have been conducted outside the record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients — NCT00190671.
- Registry record last updated 2009-11-20; status last verified 2009-11.
- Results first posted 2009-07-16.
- 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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17. Record Summary
NCT00190671 is a completed phase 1/2 study of pemetrexed and cyclophosphamide in locally advanced or metastatic breast cancer. The phase 1 portion is described as a single-arm dose-finding study intended to establish the maximum tolerated dose. The phase 2 portion is described as randomized and parallel, with groups labeled Pemetrexed 600 mg/m2 and Pemetrexed 1800 mg/m2. The study is listed as unmasked, with overall enrollment of 103.
The primary outcome is best tumor response among randomized participants, assessed by radiological imaging. Imaging was repeated every 6 weeks prior to every other cycle, and response confirmation was to occur no less than 4 weeks (28 days) after first evidence of response. Secondary outcomes include disease-progression and pharmacokinetic measures.
The registry record does not report analyses of the primary outcome, arm-specific enrollment, or the numbers at risk for adverse events. It lists serious and other adverse-event counts and several serious-event terms with percentages, but these entries do not provide a complete comparative analysis. The study began in 2005-06 and reached primary completion in 2008-03.