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 | aggressive |
| Linked regimen | REG-DATO-DXD-BREAST-2L |
| ID | IND-BREAST-TNBC-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
Aggressive-track only. TROPION-Breast02 (NCT05374512): Phase III, 1L PD-L1-low/-negative metastatic TNBC, Dato-DXd vs investigator- choice chemo. Topline PFS not yet reported; FDA Datroway label (Jan 2025) does NOT cover TNBC — current standard 2L+ TNBC TROP2 ADC is sacituzumab govitecan (ASCENT). This indication exists as an aggressive-track placeholder for patients who failed sacituzumab + post-IO chemo and have access via clinical trial / EAP. When TROPION-Breast02 readout lands positive, downgrade evidence_level to high + strength to strong + plan_track to standard. Trial- source SRC-TROPION-BREAST02 not yet ingested into KB — citations fall back to NCCN + ESMO guideline Sources; flagged for follow-up source-stub generation. UA access: not registered.
Used By
No reverse references found in the YAML corpus.