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 First Line Therapy for Patients With Metastatic Breast Cancer (NCT00456846), a na phase 2 study. The primary outcome is Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00456846 |
| Phase | Phase 2 |
| Condition | Metastatic Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 123 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Celgene |
| Results posted | Yes |
2. Clinical Question
Population
People with metastatic breast cancer were the population of interest. The study description distinguishes participants who had received taxanes as part of adjuvant therapy from those who had not. The primary endpoint population is defined as the treated population: enrolled participants who received at least one dose of study drug. The registry enrollment is listed as 123, but the number meeting that treated-population definition is not reported in the registry record.
Intervention
The intervention was ABI-007, identified in the study description as nab-paclitaxel. The planned regimen was 100 mg/m^2 by intravenous infusion over 30 minutes weekly for 3 weeks, followed by 1 week of rest. Therapy was to continue until disease progression or unacceptable toxicity.
Comparator
There was no randomized control group: the registry lists the study model as single-group and allocation as NA. The prior-taxane and no-prior-taxane groups are participant strata, not like-for-like randomized treatment arms. A comparative treatment effect against another therapy is therefore not established by this design.
Primary question
The primary question was what percentage of treated participants had a confirmed complete or partial overall response, assessed by investigators and independent reviewers under RECIST Version 1.0. Response was assessed every 8 weeks from study start until disease progression, for up to 61 months. The registry record describes the endpoint but does not report the observed response percentage or its 95% confidence interval.
3. Trial Design
This was an open-label, Phase II study of ABI-007 as first-line therapy for metastatic breast cancer. The registry lists a single-group model, no masking, and allocation as NA. These design features mean that the study was not a randomized comparison of ABI-007 with another treatment. Participants and study personnel were not masked according to the record.
The study description distinguishes people who had received taxanes during adjuvant therapy from those who had not. Those categories can describe differences within the enrolled population, but they do not create a randomized control group. Any apparent difference between those categories could reflect differences in the participants or their prior treatment history as well as differences in outcomes. The record does not report a plan for adjusting such comparisons.
ABI-007 was administered at 100 mg/m^2 by intravenous infusion over 30 minutes weekly for 3 weeks, followed by 1 week of rest. Treatment was described as continuing until disease progression or unacceptable toxicity. The registry lists enrollment as 123. Its primary-endpoint population is defined as all enrolled participants who received at least one dose; the number in that population is not reported in the registry record.
The study start is listed as 2008-02-01, and primary completion as 2012-12-11. The status is terminated. The reason for termination is not reported in the registry record, so the status alone does not establish why the study ended or whether the planned enrollment or follow-up was completed.
The primary endpoint was confirmed complete or partial overall response according to RECIST Version 1.0, assessed by investigators and independent reviewers. Other listed outcomes include disease control, progression-free survival, duration of response, patient survival, dose changes, and treatment-emergent adverse events. The registry record does not report a detailed statistical analysis plan or a sample-size justification.
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 | Abraxane (Prior Taxane Therapy) | Abraxane (No Prior Taxane Therapy) |
|---|---|---|
| STARTED | 47 | 76 |
| COMPLETED | 31 | 48 |
| NOT COMPLETED | 16 | 28 |
Reasons for not completing this period:
| Reason | Abraxane (Prior Taxane Therapy) | Abraxane (No Prior Taxane Therapy) |
|---|---|---|
| Adverse Event | 2 | 15 |
| Physician Decision | 11 | 6 |
| Protocol Deviation | 2 | 0 |
| Participant Discretion | 1 | 5 |
| Other | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.
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: Treated Population
| Characteristic | Unit | Abraxane (Prior Taxane Therapy) | Abraxane (No Prior Taxane Therapy) | Total |
|---|---|---|---|---|
| Participants analysed | 47 | 76 | 123 | |
| Age, Continuous | years | 55.3 (SD 9.78) | 58.3 (SD 10.88) | 57.2 (SD 10.54) |
| Sex: Female, Male: Female | Participants | 47 | 76 | 123 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian | participants | 0 | 5 | 5 |
| Race/Ethnicity, Customized: Black, of African Heritage | participants | 2 | 3 | 5 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: White, Non-Hispanic/Non Latino | participants | 41 | 60 | 101 |
| Race/Ethnicity, Customized: White, Hispanic or Latino | participants | 0 | 5 | 5 |
| Race/Ethnicity, Customized: Other-Unspecified | participants | 3 | 3 | 6 |
| Menopausal Status: Premenopausal | participants | 12 | 12 | 24 |
| Menopausal Status: Postmenopausal | participants | 35 | 64 | 99 |
| Stage at Primary Diagnosis: Stage I | participants | 4 | 12 | 16 |
| Stage at Primary Diagnosis: Stage IIa | participants | 7 | 12 | 19 |
| Stage at Primary Diagnosis: Stage IIb | participants | 14 | 13 | 27 |
| Stage at Primary Diagnosis: Stage IIIa | participants | 11 | 8 | 19 |
| Stage at Primary Diagnosis: Stage IIIb | participants | 6 | 4 | 10 |
| Stage at Primary Diagnosis: Stage IIIc | participants | 5 | 5 | 10 |
| Stage at Primary Diagnosis: Stage IV | participants | 0 | 19 | 19 |
| Stage at Primary Diagnosis: Unknown | participants | 0 | 3 | 3 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 (fully active) | participants | 21 | 38 | 59 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 1 (restrictive but ambulatory) | participants | 22 | 30 | 52 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 2 (ambulatory but unable to work) | participants | 4 | 8 | 12 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 3 (limited self-care) + 4 (completely disabled) | participants | 0 | 0 | 0 |
| Physician Assessment of Peripheral Neuropathy] [2]: Grade 0 | participants | 37 | 69 | 106 |
| Physician Assessment of Peripheral Neuropathy] [2]: Grade 1 | participants | 10 | 7 | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers, measured over Every 8 weeks from study start until disease progression; Up to 61 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with an objective confirmed complete or partial overall response under RECIST Version 1.0. Overall response combines complete response, meaning disappearance of all known disease under the specified criteria, and partial response, meaning a confirmed reduction in the sum of the longest diameters of target lesions under the specified criteria. Confirmation was required at least 4 weeks after initial documentation. The endpoint description also gives criteria concerning non-target lesions and tumor markers.
Response rate is a binary outcome at the participant level: each participant either meets the response definition or does not. Reporting the percentage gives a direct description of how often the defined response occurred in the endpoint population. The registry lists assessment by both investigators and independent reviewers, which allows the endpoint to be evaluated from those assessment perspectives. The record does not report whether their estimates agreed or how any disagreement was handled.
In general, a response endpoint can summarize tumor change over the assessment period, but it does not by itself describe how long a response lasts, whether disease later progresses, or overall survival. Those are distinct outcomes, and the registry lists duration of response, progression-free survival, and patient survival separately. The primary response percentage and its 95% confidence interval are not reported in the registry record, so the frequency and precision of the observed primary outcome cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically defined primary outcome: confirmed complete or partial response under RECIST Version 1.0. It also defines the treated population and states that investigators and independent reviewers assessed response. These details clarify what the endpoint was intended to measure. They do not, on their own, show how many participants responded or how uncertain that estimate was.
The primary response percentage and its 95% confidence interval are not reported in the registry record. Consequently, the posted information does not permit a quantitative reading of the primary endpoint. It is not possible to describe the observed response frequency, the range of values compatible with the data, or whether investigator and independent-review assessments differed. No p-value or other inferential result for the primary outcome is reported.
The trial was open-label and single-group, with allocation listed as NA. Therefore, even if a response estimate were available, it would describe outcomes observed among participants receiving ABI-007 in this study; the design does not supply a randomized counterfactual for what would have happened to comparable participants under another treatment. The prior-taxane and no-prior-taxane categories do not change that design. They are not randomized comparator arms, and the registry record does not report an adjusted analysis comparing them.
Response was scheduled for assessment every 8 weeks from study start until disease progression, with a timeframe of up to 61 months. This timing describes the planned observation window in the endpoint record; it does not establish how many participants completed assessments or how much follow-up was achieved. Those details are not reported in the registry record.
The status is listed as terminated, but the reason is not reported in the registry record. Termination alone cannot establish whether the study stopped early, whether the primary endpoint was unavailable, or whether any particular result influenced the decision. The registry lists enrollment as 123, while the endpoint population is defined by receipt of at least one dose. The number actually included in that population is not reported.
In general, a confidence interval communicates the statistical uncertainty around an estimated response percentage. A wider interval indicates less precision than a narrower interval, but its interpretation depends on the estimate and the data supporting it. Since neither the primary estimate nor its interval is reported, the precision of the primary result cannot be assessed. The available record supports interpretation of the study question, endpoint definition, regimen, and design limitations—not a conclusion about the magnitude of response or comparative treatment effects.
9. Statistical Methods Explained
What kind of outcome was the primary endpoint?
In general, a percentage based on whether each participant meets a defined response criterion is a binary outcome. The endpoint classifies participants as having a confirmed complete or partial response, or as not meeting that response definition. The registry describes overall response as complete response plus partial response, with confirmation at least 4 weeks after the first documentation. The specified RECIST Version 1.0 criteria concern changes in target lesions and also describe how non-target lesions and tumor markers are considered.
A response percentage is useful because it expresses the observed frequency of a defined outcome in the analyzed population. It is not interchangeable with the change in tumor size for an individual participant, duration of response, progression-free survival, or patient survival. The registry lists several of those other outcomes separately. The primary percentage and its confidence interval are not reported in the registry record, so the endpoint definition cannot be paired with an observed estimate.
What does a confidence interval convey?
In general, a confidence interval describes uncertainty around an estimated quantity under the statistical method used. For a response percentage, the interval indicates how precisely the study estimates the response frequency in its analyzed population. It does not guarantee that the true value lies within the interval, and it does not by itself establish a treatment effect relative to another therapy. Interpretation also depends on the study design, outcome definition, population, and analysis methods.
The registry specifies a 95% confidence interval for the primary endpoint, but does not report the interval or the response estimate. Thus, there is no reported interval width to assess and no basis for comparing precision across reviewers or subgroups.
Why do the assessment sources matter?
The endpoint title names both investigators and independent reviewers as assessors. In general, an independent assessment can provide a perspective separate from the treating investigators, while investigator assessment reflects the study team's evaluation. The presence of both does not mean their results were identical or that one was designated as controlling. The registry record does not report the separate estimates, any agreement analysis, or a rule for resolving differences.
Because the study was open-label, masking was absent. In general, knowledge of treatment can influence subjective judgments or the conduct and timing of assessments, even when an endpoint follows defined criteria. The use of RECIST criteria and independent review are relevant features to consider, but the record does not provide enough information to assess how assessment procedures were implemented or whether review was blinded to other information.
How does the design shape inference?
The record describes a single-group Phase II study with allocation listed as NA. In general, an estimate from a single group describes outcomes observed under the study regimen; without a randomized comparator, it cannot isolate the effect of treatment from other explanations. The prior-taxane and no-prior-taxane categories are not randomized treatment comparisons. Differences between them, if reported, could reflect differences in participant characteristics or treatment history. The registry record does not report a statistical plan for subgroup comparisons or adjustment.
General statistical comparisons can be affected by over-dispersion: observed variability may exceed what a simple model assumes, making standard errors too small and intervals too narrow if the extra variability is ignored. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report a model for the primary outcome, so it is not possible to say whether over-dispersion was assessed or how uncertainty was calculated.
What cannot be inferred from the registry results?
The record lists the primary endpoint definition but does not report the primary response count, percentage, or confidence interval. It also reports no analysis records. No p-value, model estimate, or adjusted result for the primary outcome is available in the registry record. General explanations of confidence intervals and binary outcomes clarify the intended interpretation, but they cannot recover missing estimates.
In general, planned sample-size calculations depend on a target effect, variability or event assumptions, significance level, power, allocation, and analysis method. A planning illustration is not an observed result and does not establish the precision achieved in a completed study. The registry record does not report its own sample-size justification or statistical plan. No claim about observed power or the adequacy of enrollment follows from the listed enrollment alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes in addition to the primary response endpoint, including disease control, progression-free survival, duration of response, patient survival, dose changes, and treatment-emergent adverse events. Considering multiple outcomes can raise a multiplicity issue: when many statistical questions are tested, the chance of at least one apparently unusual result can increase. In general, a statistical plan may specify how to prioritize outcomes or account for multiple testing. Such a plan is not reported in the registry record, and no outcome analysis records are listed.
The record does not report a multiplicity adjustment, a testing hierarchy, or an explanation of how results across investigator and independent-review assessments were handled. It is therefore not possible to determine whether any adjustment was intended or applied. The registry's endpoint description alone does not establish that a particular analysis was confirmatory.
The primary analysis population is defined as enrolled participants who received at least one dose of study drug. The number in that population is not reported in the registry record. The enrollment figure is listed as 123, but it should not be treated as the analyzed primary-endpoint denominator without the reported population count and outcome data.
Missing outcome data and the handling of participants without an evaluable response are not described in the registry record. In general, missingness can affect an estimated percentage if participants with unavailable assessments differ from those assessed. Statistical approaches may use different assumptions about missing outcomes, so the analysis population and missing-data rules matter for interpretation. No imputation method, sensitivity analysis, or accounting of unavailable response assessments is reported.
The registry does not report interim analyses or stopping rules. It also does not report a detailed statistical analysis plan or sample-size justification. These absences prevent assessment of whether analysis choices were prespecified or how they may have affected interpretation.
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 |
|---|---|---|---|
| Abraxane (Prior Taxane Therapy) | 5 | 47 | 10.6% |
| Abraxane (No Prior Taxane Therapy) | 14 | 76 | 18.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5.0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Abraxane (Prior Taxane Therapy) | 46 of 47 |
| Abraxane (No Prior Taxane Therapy) | 75 of 76 |
Most frequent serious adverse event terms
| Event term | Organ system | Abraxane (Prior Taxane Therapy) | Abraxane (No Prior Taxane Therapy) |
|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 47 | 3 of 76 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 47 | 2 of 76 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0 of 47 | 2 of 76 |
| Bacteraemia | Infections and infestations | 1 of 47 | 0 of 76 |
| Bronchopneumonia | Infections and infestations | 0 of 47 | 1 of 76 |
| Cellulitis | Infections and infestations | 1 of 47 | 0 of 76 |
| Histoplasmosis | Infections and infestations | 0 of 47 | 1 of 76 |
| Lung infection | Infections and infestations | 0 of 47 | 1 of 76 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 47 | 1 of 76 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 0 of 47 | 1 of 76 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Abraxane (Prior Taxane Therapy) | Abraxane (No Prior Taxane Therapy) |
|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | 29 of 47 | 61 of 76 |
| Fatigue | General disorders | 33 of 47 | 55 of 76 |
| Nausea | Gastrointestinal disorders | 24 of 47 | 47 of 76 |
| Peripheral sensory neuropathy | Nervous system disorders | 22 of 47 | 44 of 76 |
| Diarrhoea | Gastrointestinal disorders | 15 of 47 | 37 of 76 |
| Decreased appetite | Metabolism and nutrition disorders | 16 of 47 | 30 of 76 |
| Headache | Nervous system disorders | 17 of 47 | 20 of 76 |
| Vomiting | Gastrointestinal disorders | 13 of 47 | 22 of 76 |
| Oedema peripheral | General disorders | 13 of 47 | 22 of 76 |
| Nail disorder | Skin and subcutaneous tissue disorders | 12 of 47 | 20 of 76 |
Serious events with the highest arm-level rate: pneumonia (3.9%), pleural effusion (2.6%), pulmonary embolism (2.6%), bacteraemia (2.1%), cellulitis (2.1%).
The registry lists serious and other adverse-event counts for the prior-taxane and no-prior-taxane groups. For the group titled Abraxane (Prior Taxane Therapy), the at-risk count is 47, with 5 participants listed as having a serious adverse event and 46 as having another adverse event. For Abraxane (No Prior Taxane Therapy), the at-risk count is 76, with 14 listed as having a serious adverse event and 75 as having another adverse event. These are descriptive registry counts; they do not constitute a randomized safety comparison.
The registry also lists serious adverse-event terms with percentages: pneumonia, 3.9%; pleural effusion, 2.6%; pulmonary embolism, 2.6%; bacteraemia, 2.1%; cellulitis, 2.1%; and pneumothorax, 2.1%. These figures describe the listed terms, but the record does not explain in this entry whether people could contribute to more than one term or provide further detail about the calculation. They should not be added together or interpreted as a total adverse-event percentage.
In general, adverse-event counts describe events observed and recorded under the study's definitions; they do not by themselves establish causation. The registry does not report deaths in these group entries. It also does not provide enough information to assess duration of exposure, event severity beyond the serious classification, or comparative risk against another treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase II, open-label, single-group study evaluated weekly ABI-007 as first-line therapy for metastatic breast cancer. It specifies the treatment regimen, the prior-taxane categories, the primary response definition, and several additional outcomes. These details show what the study set out to assess and how the primary outcome was defined.
The primary response percentage and its 95% confidence interval are not reported in the registry record. Therefore, the posted results do not show the observed frequency of confirmed complete or partial response or the precision of that estimate. They do not allow a reader to judge how the observed response compares with a benchmark, nor do they support a conclusion about response magnitude.
The single-group design also limits what the study can establish. Without a randomized control group, outcomes among participants receiving ABI-007 cannot by themselves show what would have occurred under another treatment. The categories based on prior taxane therapy are not randomized comparators. Any comparison between those groups would need to be interpreted as observational, and the registry record does not report an adjusted comparison.
The registry lists safety counts and selected serious adverse-event terms, but those data are descriptive. They do not establish that the study drug caused a given event or quantify comparative safety relative to another treatment. The record's terminated status does not explain why the study ended, and it does not establish whether any particular efficacy or safety finding drove termination.
In general, a study result is interpreted in light of its outcome definitions, analysis population, missing-data handling, statistical methods, precision, and design. Several of those elements are not reported in the registry record. The evidence described in the entry can identify the question and study structure, but cannot support a conclusion about treatment benefit, lack of benefit, or comparative effectiveness.
13. Why This Trial Matters Statistically
This study illustrates why an endpoint definition and an endpoint result are different kinds of information. The registry describes a confirmed RECIST Version 1.0 response, identifies the treated population, and names investigator and independent-review assessments. Those specifications are important for understanding what a response estimate would represent. Yet without the response percentage and confidence interval, the principal quantitative evidence cannot be assessed.
The design also makes the comparison question important. A single-group, open-label study can describe outcomes observed under a regimen, but it does not provide a randomized control group for separating treatment effects from other influences. The prior-taxane categories may be relevant to describing the study population, but they are not substitutes for random allocation. This distinction prevents subgroup labels from being mistaken for treatment arms.
The record further demonstrates why registry status should not be overinterpreted. The study is marked terminated, but the reason is not reported. Status does not reveal whether termination was related to recruitment, operations, safety, efficacy, or another cause. The endpoint population is defined by treatment receipt, while the number in that population is not reported; enrollment alone cannot resolve the denominator for the primary outcome.
Statistically, the entry highlights the role of uncertainty, analysis populations, missing data, and multiplicity. A percentage without its underlying count and interval would not convey precision, and a list of several outcomes raises questions about prespecified testing and interpretation. The record does not provide those analysis details. These are not merely technical omissions: they shape how confidently findings can be interpreted and what comparisons they can support.
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.
A central limitation of the registry record is that it does not report the primary response estimate, response count, or 95% confidence interval. The primary endpoint is therefore defined but not quantitatively available for interpretation. The record also lists no analysis records, so no primary inferential result can be reviewed.
The design is single-group, open-label, and nonrandomized. It cannot provide a randomized treatment comparison, and prior-taxane history does not create a control group. The registry record does not report an adjusted comparison between the prior-taxane categories. Generalization beyond the participants enrolled in the study also cannot be assessed from the endpoint definition alone.
The entry lists enrollment as 123 but does not report the number included in the treated population defined for the primary endpoint. It does not report how many participants had evaluable response assessments, how missing assessments were handled, or whether sensitivity analyses were conducted. As a result, the denominator and potential influence of unavailable outcome data are unclear.
The record does not report a detailed statistical analysis plan, sample-size justification, multiplicity strategy, interim analyses, or stopping rules. It also does not explain the reason for terminated status. These omissions restrict assessment of prespecification, precision planning, and the context in which the study ended.
Safety information is descriptive and does not provide a randomized comparison. The registry entries do not report deaths for the listed groups, and the record does not provide further context about exposure duration or missing safety data. The adverse-event terms and counts should therefore be read as registry descriptions, not as causal or comparative estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: First Line Therapy for Patients With Metastatic Breast Cancer — NCT00456846.
- Registry record last updated 2019-11-22; status last verified 2019-11.
- Results first posted 2014-07-18.
- 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
The registry record describes NCT00456846, an open-label, Phase II, single-group study of ABI-007 as first-line therapy for metastatic breast cancer. Enrollment is listed as 123, and the study status is terminated. The record lists the study start as 2008-02-01 and primary completion as 2012-12-11.
The regimen was 100 mg/m^2 by intravenous infusion over 30 minutes weekly for 3 weeks, followed by 1 week of rest, with treatment continuing until progression or unacceptable toxicity. The primary endpoint was confirmed complete or partial response under RECIST Version 1.0, assessed by investigators and independent reviewers. Its response percentage and 95% confidence interval are not reported in the registry record.
The entry lists secondary outcomes and descriptive adverse-event information, but no analysis records. The reason for termination, detailed statistical plan, sample-size justification, treated-population count, and missing-data methods are not reported in the registry record.