TrialCurveTROIKA (final analysis): reconstructed Kaplan–Meier curves
Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting. Curves rebuilt as patient-level data (Guyot 2012) and checked against the statistics printed on the figure.
| Publication | BMC Cancer. 2023 Jan 31;23:112. doi: 10.1186/s12885-023-10574-2 |
|---|---|
| DOI | 10.1186/s12885-023-10574-2 |
| Registry | NCT03013504 |
| Phase | Phase 3 |
| Conditions | HER2 Positive Breast Cancer |
| Interventions | HD201, Herceptin, Docetaxel, Epirubicin, Cyclophosphamide |
| Sponsor | Prestige Biopharma Limited |
| Enrolment | 503 |
| Source licence | Figure published under CC BY 4.0 |
Event free survival — Per protocol set, by study arm
From figure panel A · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: HD201 not reached; Referent Trastuzumab not reached. Survival at 12 months: HD201 96%; Referent Trastuzumab 97%. Hazard ratio HD201 vs Referent Trastuzumab 0.95 (95% CI 0.59–1.53).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| HD201 | 238 | 33 | not reached |
| Referent Trastuzumab | 236 | 35 | not reached |
- HD201 vs Referent Trastuzumab: reconstructed HR 0.95 (95% CI 0.59–1.53)
Landmark survival (reconstructed)
| Time | HD201 | Referent Trastuzumab |
|---|---|---|
| 6 mo | 99.2% | 99.2% |
| 12 mo | 95.8% | 97.5% |
| 18 mo | 94.1% | 94.0% |
| 24 mo | 89.7% | 89.7% |
| 36 mo | 85.5% | 84.8% |
Checks against the published figure
- hazard ratio (direction inferred): printed 1.02, reconstructed 1.05 pass
Event free survival — Per protocol set, by total pathological complete response (tpCR) status
From figure panel C · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: With tpCR not reached; Without tpCR not reached. Survival at 12 months: With tpCR 99%; Without tpCR 94%. Hazard ratio With tpCR vs Without tpCR 0.56 (95% CI 0.34–0.94).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| With tpCR | 222 | 23 | not reached |
| Without tpCR | 252 | 43 | not reached |
- With tpCR vs Without tpCR: reconstructed HR 0.56 (95% CI 0.34–0.94)
Landmark survival (reconstructed)
| Time | With tpCR | Without tpCR |
|---|---|---|
| 6 mo | 99.5% | 98.4% |
| 12 mo | 99.1% | 94.4% |
| 18 mo | 95.9% | 90.4% |
| 24 mo | 92.7% | 87.0% |
| 36 mo | 89.3% | 82.3% |
Checks against the published figure
- hazard ratio (direction inferred): printed 0.53, reconstructed 0.565 pass
Event free survival — Per protocol set, by breast pathological complete response (bpCR) status
From figure panel D · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: With bpCR not reached; Without bpCR not reached. Survival at 12 months: With bpCR 99%; Without bpCR 95%. Hazard ratio With bpCR vs Without bpCR 0.52 (95% CI 0.31–0.88).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| With bpCR | 253 | 23 | not reached |
| Without bpCR | 221 | 36 | not reached |
- With bpCR vs Without bpCR: reconstructed HR 0.52 (95% CI 0.31–0.88)
Landmark survival (reconstructed)
| Time | With bpCR | Without bpCR |
|---|---|---|
| 6 mo | 99.6% | 99.1% |
| 12 mo | 99.2% | 94.6% |
| 18 mo | 98.0% | 90.4% |
| 24 mo | 93.5% | 87.5% |
| 36 mo | 90.5% | 83.1% |
Checks against the published figure
- hazard ratio (direction inferred): printed 0.54, reconstructed 0.523 pass
Event free survival — Modified full analysis set, by study arm
From figure panel E · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: HD201 not reached; Referent Trastuzumab not reached. Survival at 12 months: HD201 95%; Referent Trastuzumab 98%. Hazard ratio Referent Trastuzumab vs HD201 0.96 (95% CI 0.61–1.52).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| HD201 | 250 | 37 | not reached |
| Referent Trastuzumab | 252 | 37 | not reached |
- Referent Trastuzumab vs HD201: reconstructed HR 0.96 (95% CI 0.61–1.52)
Landmark survival (reconstructed)
| Time | HD201 | Referent Trastuzumab |
|---|---|---|
| 6 mo | 98.4% | 99.6% |
| 12 mo | 95.1% | 98.4% |
| 18 mo | 92.2% | 95.1% |
| 24 mo | 88.8% | 90.0% |
| 36 mo | 84.3% | 84.4% |
Checks against the published figure
- hazard ratio (direction inferred): printed 1.09, reconstructed 1.04 pass
About these data
Pseudo-IPD reproduces the published curves and numbers at risk; the rows are not real patients. Cite the publication (DOI above) and TrialCurve. The source figure is © the authors (CC BY 4.0); the charts here are redrawn from the reconstruction.
Load these data in R or Python
# R
library(survival)
d <- read.csv("https://trialcurve.com/data/trials/troika-final-analysis-1.csv")
survfit(Surv(time, event) ~ arm, data = d)
coxph(Surv(time, event) ~ arm, data = d)
# Python
import pandas as pd
from lifelines import KaplanMeierFitter
d = pd.read_csv("https://trialcurve.com/data/trials/troika-final-analysis-1.csv")
for arm, g in d.groupby("arm"):
KaplanMeierFitter().fit(g.time, g.event, label=arm).plot_survival_function()
Suggested citation: BMC Cancer. 2023 Jan 31;23:112. doi: 10.1186/s12885-023-10574-2 doi:10.1186/s12885-023-10574-2. Reconstructed data: TrialCurve (2026), https://trialcurve.com/trials/troika-final-analysis
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