Comparison · NCT00129389-dfe5b746
Arm A: FAC vs Arm B: FAC-wP: Disease-free Survival (DFS) Event
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm A: FAC vs Arm B: FAC-wP: Disease-free Survival (DFS) Event. Trial comparisons, record NCT00129389-dfe5b746. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00129389-dfe5b746
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.101 | 0.0833 | 0.121 | wilson | |
| Risk in group 2 | 0.0747 | 0.0596 | 0.0931 | wilson | |
| Risk difference, group 1 minus group 2 | 0.026 | 0.000616 | 0.0514 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 1.01 | 1.8 | log | |
| Odds ratio, group 1 over group 2 | 1.39 | 1.01 | 1.91 | log | |
| Number needed to treat, for one more participant with the outcome on Arm A: FAC than on Arm B: FAC-wP | 38.5 | 19.5 | 1,620 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A: FAC | FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks. | 98 | 974 | OG000 |
| Group 2 | Arm B: FAC-wP | FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose) | 71 | 951 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Disease-free Survival (DFS) Event
- Description
DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
- Time frame
- Up to 5 years
- Population
Source ClinicalTrials.gov
Trial
- Title
- FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
- NCT number
- NCT00129389
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Fluorouracil, Doxorubicin, Cyclophosphamide, Paclitaxel
- Lead sponsor
- Spanish Breast Cancer Research Group
- Results first posted
- 2019-07-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00129389?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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