Comparison · NCT04770272-sae
Arm A vs Arm B: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A vs Arm B: serious adverse events. Trial comparisons, record NCT04770272-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04770272-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 | 0.483 | 0.411 | 0.556 | wilson | |
| Risk in group 2 | 0.489 | 0.416 | 0.562 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00562 | -0.108 | 0.0972 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.989 | 0.798 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.978 | 0.645 | 1.48 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A than on Arm B | 178 | 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 | Arm A | 2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.~Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks~Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles~Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles~Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles~Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)~Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)~Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.~Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients. | 86 | 178 | EG000 |
| Group 2 | Arm B | 12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.~Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles~Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles~Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles~Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)~Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)~Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.~Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients. | 87 | 178 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
Source ClinicalTrials.gov
Trial
- Title
- Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy
- NCT number
- NCT04770272
- Phases
- PHASE2
- Conditions
- Triple-negative Breast Cancer
- Interventions
- Atezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection, Carboplatin, Paclitaxel, Epirubicin, Cyclophosphamide, Biopsy Arm A, Biopsy Arm B, Surgery
- Lead sponsor
- Palleos Healthcare GmbH
- Results first posted
- 2026-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04770272?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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