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Datopotamab deruxtecan (Dato-DXd) monotherapy (HR+/HER2- pre-treated metastatic post-ET + chemo)

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ComponentsDRUG-DATOPOTAMAB-DERUXTECAN
IDREG-DATO-DXD-BREAST-2L
TypeRegimen
Statuspending_clinical_signoff
DiseasesNone declared
SourcesSRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025

Notes

TROPION-Breast01 (NCT05104866): Phase III, HR+/HER2- pre-treated metastatic breast cancer (1-2 prior chemo lines for metastatic + prior endocrine therapy). Dato-DXd vs investigator-choice chemo (eribulin / vinorelbine / gemcitabine / capecitabine). Median PFS 6.9 vs 4.9 mo (HR 0.63). FDA approval Jan 2025 (Datroway) for HR+/ HER2- (IHC 0, IHC 1+, IHC 2+/ISH-) metastatic post-ET + chemo. Distinguishing AE profile vs T-DXd: higher stomatitis + ocular toxicity, lower (~3% vs ~12%) ILD rate. TROP2-IHC not required as predictive biomarker per current label (broad-eligibility). Bibliographic record SRC-TROPION-BREAST01-BARDIA-2024 is available; clinical claim linkage requires dual clinical sign-off.

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