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 Breast Cancer Risk Biomarkers in Postmenopausal Women (NCT01252290), a na phase 2 study. The primary outcome is The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01252290 |
| Phase | Phase 2 |
| Condition | Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Carol Fabian, MD |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women under the age of 50 are the population described for the primary feasibility question. The study concerns breast cancer risk biomarkers. The registry record lists 35 participants enrolled, but does not provide a more detailed description of who was eligible or who contributed data to the primary endpoint.
Intervention
Participants were assigned Lovaza™, described as two 1 gram capsules twice daily for six months. The primary endpoint description identifies the intended daily dose as 4 grams. The study was designed to gather information about changes in blood and tissue risk biomarkers.
Comparator
There was no separate control group. The record describes a single-group study, with allocation listed as not applicable and no masking. The intervention group therefore cannot be compared with a concurrent untreated or alternative-treatment group in this study.
Primary question
What proportion of enrolled participants completed the six-month Lovaza™ intervention? This is a feasibility question about completion, rather than a direct test of whether the intervention changes breast cancer risk or biomarkers. The registry record does not report the completion result.
3. Trial Design
This is a phase 2, single-group intervention study, listed as completed. The registry record gives an enrollment of 35. It lists no allocation scheme and describes masking as none. Because there is no concurrent comparator group, the design is not a randomized treatment comparison. The trial was sponsored by Carol Fabian, MD.
Participants were to take Lovaza™ for six months, described as two 1 gram capsules twice daily. The brief summary says the study was designed to gather information about the effects of prescription omega-3 fatty acids on blood and tissue risk biomarkers for breast cancer. It also notes that Lovaza™ is approved by the FDA for reducing blood triglyceride levels; that background does not establish what the study found about breast cancer biomarkers.
The primary outcome is framed as the proportion of enrolled participants who complete the intervention, with assessment at the six-month visit. Listed secondary outcomes concern the Masood Score, the DHA+EPA:AA ratio for plasma phospholipids, quality of life, and Ki-67 expression. The record lists five outcome measures overall but records no outcome analyses. It does not report the numerical result for the primary outcome.
The study start is listed as 2010-11 and primary completion as 2013-05. These dates and the completed status describe the study record, but they do not establish how many participants completed treatment or how biomarker values changed. Details such as the intended analysis population, adherence assessment, and full statistical 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.
Overall Study
| Stage | Lovaza™ |
|---|---|
| STARTED | 35 |
| COMPLETED | 34 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Lovaza™ |
|---|---|
| Withdrawal by Subject | 1 |
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 | Lovaza™ |
|---|---|---|
| Participants analysed | 35 | |
| Age, Continuous | years | 53.2 (SD 8.4) |
| Gender: Female | Participants | 35 |
| Gender: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 35 |
| Weight | kilograms | 71 (SD 14) |
| Body Mass Index | kg/m2 | 26.2 (SD 4.7) |
| 5-Year Gail Risk | percent probablity of breast cancer | 3.4 (SD 1.5) |
6. Primary Endpoint
The registry lists the primary outcome as The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day, measured over 6 month visit.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | proportion of enrolled participants |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the proportion of enrolled participants who complete six months of Lovaza™ intervention, assessed at the six-month visit. The endpoint description identifies the target as postmenopausal women under the age of 50 and describes a daily dose of 4 grams. The intervention description specifies two 1 gram capsules twice daily.
Completion is a feasibility outcome: it asks whether participants stay in the intervention through the planned period. In general, feasibility measures can inform whether a regimen and follow-up schedule are workable for the population being studied. They do not, by themselves, show whether a treatment changes a biomarker or reduces disease risk.
The registry record does not report the number or proportion who completed the intervention. It therefore does not allow the completion rate to be assessed, nor does it explain how completion was defined in practice, how withdrawals were handled, or whether participants with missing six-month status were included in the denominator. These endpoint details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record describes the question and study structure, but it does not report the primary endpoint result. Although the primary outcome is completion at the six-month visit, no count or proportion of participants completing treatment is given. The study is marked completed, but that status is not a substitute for an endpoint result and should not be interpreted as evidence that all participants completed the intervention.
The registry record lists five outcome measures and no recorded analyses. It names secondary outcomes concerning the Masood Score, plasma phospholipid DHA+EPA:AA ratio, quality of life, and Ki-67 expression, but it does not give numerical changes, uncertainty estimates, or inferential results for them. As a result, the posted information does not establish the magnitude or precision of any change in these outcomes.
The design also limits what can be concluded from any before-and-after changes that might have occurred. The study has one intervention group and no concurrent comparator. In general, measurements made in a single group can describe changes over time, but without a comparison group it can be difficult to separate intervention-related changes from other explanations, including changes that might have occurred over time regardless of intervention. The registry record does not report enough outcome detail to evaluate such changes in this study.
General statistical interpretation depends on both an estimated effect and its uncertainty. A confidence interval, for example, describes a range of values compatible with the data and the method used; a narrower interval generally indicates greater precision. No confidence interval or other uncertainty estimate for the primary completion outcome is reported in the registry record. No p-value for that outcome is reported either.
The serious and other adverse-event figures are descriptive registry entries, not a comparative safety analysis. There is no control group against which to compare them, and the record does not report causal attribution. The listed serious-event terms and percentages do not resolve whether an event was related to the intervention. Overall, the posted information is insufficient to judge the completion result, biomarker changes, or comparative effects.
9. Statistical Methods Explained
The primary outcome is a count-based proportion: the endpoint asks how many enrolled participants completed the intervention by the six-month visit. The registry record gives the endpoint definition but not its observed count or proportion. It also does not report a confidence interval, a test statistic, or an analysis population for this outcome. Without these details, the feasibility result cannot be quantified or assessed for precision.
What does a proportion estimate?
In general, a proportion represents the share of a defined group meeting a specified condition. Its interpretation depends on a clear numerator and denominator. For a completion endpoint, the numerator would reflect participants meeting the completion definition, while the denominator would depend on the stated analysis population. The registry record identifies enrolled participants in the outcome title, but does not explain how missing six-month status or withdrawals were handled. Consequently, the actual numerator, denominator, and completion proportion are not reported in the registry record.
Why does the single-group design matter?
In general, a single-group study can describe outcomes among participants receiving an intervention, but it cannot estimate a treatment contrast against a concurrent control group. Natural change over time, co-occurring events, measurement variation, and selection into follow-up may affect observed measurements. A randomized comparison can help address some of these concerns; this registry record does not describe such a comparison. The study is listed as single group, with allocation not applicable and no masking.
The study's listed secondary outcomes include biomarker and quality-of-life measures. In general, continuous outcomes may be analyzed using changes from baseline, final values, or other specified models, depending on the protocol and data structure. The registry record does not state which approach was used, how repeated measurements were handled, or what statistical model was specified. It also does not provide numerical outcome estimates. Those analytic details are not reported in the registry record.
What can planning calculations tell a reader?
General sample-size calculations are prospective planning tools: they describe the amount of information a hypothetical study would need under stated assumptions. The registry record's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a stated fraction of an observed effect. For time-to-event calculations, the assumption describes a total number of events; other calculations are expressed as participants per arm. These are planning illustrations, not observed power, and they are not the design of this single-group study.
The primary outcome result and the observed effect used in any such planning illustration are not reported in the registry record. That makes it impossible to judge how a hypothetical planning scenario relates to the study's actual data. The assumptions should not be taken as evidence that the study was designed with those features or that it had a particular ability to detect an effect.
Why is uncertainty important?
In general, an estimate alone does not show how much it may vary because of sampling uncertainty. A confidence interval can communicate that uncertainty, while a hypothesis test addresses a question under a specified statistical model. Neither measure replaces the need to understand the outcome definition, missing data, analysis population, and study design. For this study, the registry record does not report an estimate or uncertainty measure for the primary endpoint, nor does it record analyses for the listed outcome measures.
Over-dispersion is a general concern for count data when observed variability exceeds what a basic count model assumes. If present, it can make conventional standard errors too small and confidence intervals too narrow. The record does not report a count-model analysis or information that would allow over-dispersion to be assessed, so this is a general methodological consideration rather than a finding about the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists the completion outcome as primary and names four secondary outcomes: the Masood Score, the DHA+EPA:AA ratio for plasma phospholipids, quality of life, and Ki-67 expression. It lists five outcome measures overall and no recorded analyses. Numerical results and analysis details for the outcomes are not reported in the registry record.
When a study evaluates multiple outcomes, general statistical practice distinguishes a prespecified primary question from additional questions. Testing many outcomes can increase the chance of observing an apparently notable result by chance. A statistical plan may address this through a hierarchy, adjustment, or interpretation focused on estimation rather than a collection of tests. The registry record does not report whether any multiplicity strategy was planned or used, and no analyses are recorded. The absence of those details prevents assessment of how multiple outcomes were handled.
The record also does not describe missing-data procedures, the number of participants with outcome data at each visit, or the population included in each analysis. For the completion endpoint, it does not state how a participant with no six-month status was classified. For secondary outcomes, it does not state whether measurements were available at baseline and follow-up or how incomplete measurements were addressed. These details are not reported in the registry record.
In general, missingness can affect interpretation when participants with observed data differ from those without data. The completed status and enrollment count do not resolve that issue. Without outcome counts, analysis populations, and missing-data methods, the extent and possible impact of missing information cannot be assessed.
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 |
|---|---|---|---|
| Lovaza™ | 2 | 35 | 5.7% |
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 |
|---|---|
| Lovaza™ | 14 of 35 |
Most frequent serious adverse event terms
| Event term | Organ system | Lovaza™ |
|---|---|---|
| Ductal carcinoma in situ | Reproductive system and breast disorders | 1 of 35 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | 1 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Lovaza™ |
|---|---|---|
| acid reflux | Gastrointestinal disorders | 3 of 35 |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | 3 of 35 |
| Breast biopsy | Reproductive system and breast disorders | 2 of 35 |
| Diarrhea | Gastrointestinal disorders | 2 of 35 |
| Nausea | Gastrointestinal disorders | 2 of 35 |
| Urinary tract infection | Renal and urinary disorders | 2 of 35 |
| Breast pain | Reproductive system and breast disorders | 2 of 35 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | 2 of 35 |
Serious events with the highest arm-level rate: ductal carcinoma in situ (2.9%), gastroesophageal reflux disease (2.9%).
The registry record reports 35 participants at risk for serious adverse events and 2 affected, and 35 at risk for other adverse events and 14 affected. It lists ductal carcinoma in situ and gastroesophageal reflux disease among the top serious-event terms, each with a reported frequency of 2.9%. Deaths are not reported in the registry record.
These entries should be read as descriptive counts and listed terms, not as evidence that Lovaza™ caused an event. The record does not report causal attribution, timing, event-level detail, or a comparison group. It also does not explain whether an affected participant could contribute to more than one event term. The term-specific percentages should not be treated as a comparative risk estimate.
In general, adverse-event summaries depend on consistent definitions, follow-up, and ascertainment. A single-group count cannot establish how the observed frequency compares with what would have occurred without the intervention. The registry record does not provide enough information to make that comparison or to determine whether the listed events were considered related to treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a single-group phase 2 study was conducted to examine a six-month Lovaza™ intervention in postmenopausal women, with feasibility of completion as its primary question. It also identifies planned biomarker and quality-of-life outcomes. These elements clarify what the study set out to investigate, but they do not supply the outcome findings needed to answer those questions.
The primary completion result is not reported in the registry record. Therefore, the proportion who completed the intervention and the precision of that estimate cannot be assessed. The listed secondary outcomes also have no numerical results or recorded analyses. No conclusions about changes in the Masood Score, plasma phospholipid DHA+EPA:AA ratio, quality of life, or Ki-67 expression can be drawn from the posted information.
Even if measurements had changed during follow-up, a single-group design would not show how those changes compare with an untreated or alternative-treatment group. In general, a before-and-after pattern is not equivalent to a controlled estimate of an intervention effect. The record gives no comparator and does not report analyses that would quantify an intervention effect.
The adverse-event counts provide descriptive information for the participants at risk in the registry entry. They do not establish causation or comparative safety. Taken together, the available record describes the design, outcomes of interest, and some safety entries, but not the primary result or analyzed biomarker results. It therefore does not support a conclusion about intervention efficacy, biomarker benefit, or comparative safety.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between feasibility and efficacy. Its primary question is whether participants complete a six-month intervention, while its secondary questions concern biomarkers and quality of life. Those outcomes answer different questions: completion describes participation in the regimen, whereas biomarker measures describe biological outcomes. Neither type of result can stand in for the other.
The single-group design also makes the role of comparison clear. A study can describe what happened among participants receiving an intervention, but causal interpretation usually needs a suitable comparison and a clear analysis plan. This record identifies no control group. That design feature matters when interpreting any changes over time, even if numerical results were available.
The registry record demonstrates why outcome definitions and analysis details matter alongside an enrollment count and a completed status. For the primary outcome, the result depends on how completion and missing follow-up are defined. For secondary outcomes, the result depends on how measurements and multiple questions are handled. Those details and the numerical analyses are not reported in the registry record.
Finally, the record distinguishes planning assumptions from the actual study design. General sample-size illustrations based on hypothetical two-arm comparisons cannot be read as evidence about the power or results of a single-group trial. The central statistical lesson is to keep the design, endpoint, analysis, and strength of inference aligned.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation of the available record is that it does not report the primary completion result. It also records no outcome analyses, leaving no numerical findings for the listed secondary outcomes. Without estimates or uncertainty measures, readers cannot evaluate the magnitude or precision of the outcomes the study set out to assess.
The design has no concurrent comparator and no masking. As a single-group study, it cannot provide a direct contrast with another treatment or with no intervention. This limits causal interpretation of any observed changes, although the registry record does not provide the changes themselves.
The record does not report how completion was defined in practice, how withdrawals or missing six-month data were handled, or which participants were included in each analysis. It does not provide the statistical methods used for secondary outcomes, a multiplicity approach, or a detailed analysis plan. These omissions prevent assessment of potential bias and analytic choices.
Enrollment is listed as 35, but the record does not state how many participants contributed data to each outcome. The adverse-event entries are descriptive and do not include causal attribution or a comparator. These limitations apply to interpretation of the registry information; they do not establish what analyses may have been conducted outside the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Breast Cancer Risk Biomarkers in Postmenopausal Women — NCT01252290.
- Registry record last updated 2016-12-16; status last verified 2016-10.
- Results first posted 2016-12-16.
- 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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18. Record Summary
The registry record describes a completed phase 2, single-group study of Lovaza™ in postmenopausal women, with 35 participants enrolled. The intervention was described as two 1 gram capsules twice daily for six months. The primary endpoint was the proportion completing the intervention at the six-month visit.
Four secondary outcomes concern the Masood Score, plasma phospholipid DHA+EPA:AA ratio, quality of life, and Ki-67 expression. The record lists five outcome measures and no recorded analyses. It does not report the primary completion result or numerical results for the secondary outcomes. Serious and other adverse-event counts are listed descriptively, without a concurrent comparison group or reported causal attribution.