Comparison · NCT01349322-sae
Whole Breast Irradiation + Sequential Boost vs Hypofractionated Whole Breast Irradiation + Concurrent Boost: serious adverse events
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. Whole Breast Irradiation + Sequential Boost vs Hypofractionated Whole Breast Irradiation + Concurrent Boost: serious adverse events. Trial comparisons, record NCT01349322-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01349322-sae
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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 | 0.0164 | 0.0104 | 0.0257 | wilson | |
| Risk in group 2 | 0.0178 | 0.0116 | 0.0273 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00145 | -0.0127 | 0.00981 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.919 | 0.489 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 0.917 | 0.483 | 1.74 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Whole Breast Irradiation + Sequential Boost than on Hypofractionated Whole Breast Irradiation + Concurrent Boost | 692 | from the risk difference interval | the interval includes no difference |
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 | Whole Breast Irradiation + Sequential Boost | Standard fractionation whole breast irradiation (WBI) with sequential boost.~Standard fractionation whole breast irradiation: Target-based radiation using three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) to deliver 25 fractions of 2.0 Gy for a total dose of 50.0 Gy or 16 fractions of 2.67 Gy for a total dose of 42.7 Gy. Must begin within 9 weeks of last surgery or chemotherapy delivery.~Sequential boost: 6 fractions of 2.0 Gy per fraction for a total dose of 12 Gy or 7 fractions of 2.0 Gy for a total dose of 14 Gy to the lumpectomy cavity. May be given by either electron beam or photon beams using either 3D-CRT or IMRT. Begins without a treatment break after completion of the treatment to the entire breast. | 18 | 1,100 | EG000 |
| Group 2 | Hypofractionated Whole Breast Irradiation + Concurrent Boost | Hypofractionated whole breast (H-WBI) irradiation with a concurrent boost~Hypofractionated whole breast irradiation: Target-based radiation using three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) to deliver 15 fractions of 2.67 Gy for a total dose of 40.0 Gy. Must begin within 9 weeks of last surgery or chemotherapy delivery.~Concurrent boost: 15 fractions of 3.2 Gy for a total dose of 48 Gy to the lumpectomy cavity. Given concurrently with treatment to the entire breast. May be given by either electron beam or photon beams using either 3D-CRT or IMRT. | 20 | 1,123 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years.
Source ClinicalTrials.gov
Trial
- Title
- Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
- NCT number
- NCT01349322
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Standard fractionation whole breast irradiation, Hypofractionated whole breast irradiation, Concurrent boost, Sequential boost
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2023-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01349322?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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GET https://conductscience.org/api/comparisons/v1/NCT01349322-sae