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TROPION-Breast02

Datopotamab deruxtecan versus investigator's choice of chemotherapy in untreated advanced triple-negative breast cancer for which immunotherapy was not an option

Phase 3N = 644NCT05374512

Population
Previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option
Design
Randomised 1:1, open-label, international phase 3 trial of datopotamab deruxtecan 6 mg per kilogram every 3 weeks versus investigator's choice of chemotherapy. Randomisation stratified by geographic location, disease-free interval and PD-L1 status. Dual primary endpoints PFS (blinded independent central review, RECIST 1.1) and OS.
Primary endpoint
PFS, OS
Arms
  • Datopotamab deruxtecan (experimental, n = 323): Datopotamab deruxtecan 6 mg/kg intravenously every 3 weeks
  • Investigator's choice of chemotherapy (control, n = 321): Investigator's choice of chemotherapy
People
Dent R, senior author Traina T, TROPION-Breast02 investigators
PFSHR 0.57Δ median PFS+5.2 monthsOSHR 0.79 (95% CI 0.64–0.98)Δ median OS+5 months
Show the numbers
Results reported for TROPION-Breast02
EndpointAnalysisDatopotamab deruxtecanInvestigator's choice of chemotherapyEffect
PFSBlinded independent central review per RECIST version 1.1primaryDent 2026median 10.8 months (8.6–13.0)median 5.6 months (5–7)HR 0.57P<0.0001Hazard ratio 0.57 with a 99% CI of 0.44 to 0.73 (published interval is not a 95% CI). Grade 3 or higher treatment-related adverse events 33% vs 29%.
OSprimaryDent 2026median 23.7 months (19.8–25.6)median 18.7 months (16.0–21.8)HR 0.79 (95% CI 0.64–0.98)P=0.029The abstract gives the hazard ratio interval as 95.01% CI 0.64 to 0.98.
Results reported for TROPION-Breast02
EndpointAnalysisDatopotamab deruxtecanInvestigator's choice of chemotherapyEffect
PFSBlinded independent central review per RECIST version 1.1primaryDent 2026median 10.8 months (8.6–13.0)median 5.6 months (5–7)HR 0.57P<0.0001Hazard ratio 0.57 with a 99% CI of 0.44 to 0.73 (published interval is not a 95% CI). Grade 3 or higher treatment-related adverse events 33% vs 29%.
OSprimaryDent 2026median 23.7 months (19.8–25.6)median 18.7 months (16.0–21.8)HR 0.79 (95% CI 0.64–0.98)P=0.029The abstract gives the hazard ratio interval as 95.01% CI 0.64 to 0.98.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.790.64–0.98
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Datopotamab deruxtecan (experimental)
  • Investigator's choice of chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDatopotamab deruxtecanInvestigator's choice of chemotherapy
0100.0%100.0%
763.8%42.0%
1440.7%17.7%
2027.7%8.4%
2717.7%3.5%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Datopotamab deruxtecan (experimental)
  • Investigator's choice of chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDatopotamab deruxtecanInvestigator's choice of chemotherapy
0100.0%100.0%
1564.5%57.3%
3041.6%32.9%
4427.6%19.6%
5917.8%11.2%
Primary publication: Dent R, Shao Z, Schmid P, Cortes J, Cescon DW, Saji S, et al. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial. Ann Oncol. 2026;37(8):1066-1080. PubMedDOI

Appears in

Sources

  1. Dent R, Shao Z, Schmid P, Cortes J, Cescon DW, Saji S, et al. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial. Ann Oncol. 2026;37(8):1066-1080.

    PubMedDOI