Breast cancer (invasive) · line 2 · Datopotamab deruxtecan (Dato-DXd) monotherapy (HR+/HER2- pre-treated metastatic post-ET + chemo)
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| Line of therapy | 2 |
|---|---|
| Track | standard |
| Linked regimen | REG-DATO-DXD-BREAST-2L |
| ID | IND-BREAST-HR-POS-2L-DATO-DXD |
|---|---|
| Type | Indication |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | DIS-BREAST |
| Sources | SRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025 |
Notes
TROPION-Breast01 (NCT05104866): Phase III, HR+/HER2- metastatic breast post-ET + 1-2 prior chemo lines. Datopotamab deruxtecan (Dato-DXd) 6 mg/kg q3w vs investigator-choice chemo (eribulin / vinorelbine / gemcitabine / capecitabine). Median PFS 6.9 vs 4.9 mo (HR 0.63). FDA approval Jan 2025 (Datroway). 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 design). When HER2-low IHC 1+ / 2+ ISH- coexists, T-DXd (DESTINY-Breast04 PFS 10.1 vs 5.4 mo, HR 0.51) is preferred over Dato-DXd by efficacy margin; Dato-DXd is the option for IHC-0 (HER2-zero) patients ineligible for T-DXd. Bibliographic record SRC-TROPION-BREAST01-BARDIA-2024 is available; clinical claim linkage requires dual clinical sign-off. UA access: not registered; named-patient import / EAP only.
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