USO 22320
Estudio de fase III, abierto y aleatorizado de datopotamab deruxtecan (Dato-DXd) con o sin durvalumab en comparación con la quimioterapia elegida por el investigador (paclitaxel/nab-paclitaxel o gemcitabina+carboplatino) en combinación con pembrolizumab en pacientes con cáncer de mama triple negativo localmente recidivante, inoperable o metastásico PD-L1 positivo (TROPIONBreast05)(D7630C00001).
Tipos de enfermedades: Investigación sobre el cáncer de mama
Requisitos de elegibilidad:
• Locally recurrent inoperable or metastatic TNBC
• ER, PgR IHC < 1%, HER2 IHC 0, 1+ or 2+ with ISH-
• de novo mTNBC eligible if anthracycline is contraindicated
• PD-L1+ by 22C3 assay, CPS ≥10 IHC (centrally confirmed)
• No prior chemo or targeted systemic tx in metastatic setting
• PD must be ≥6 months after completion of tx with curative intent
• Adjuvant radiation therapy not considered tx with curative intent for
DFI
• (Neo)adjuvant anthracycline required unless contraindicated
• Prior (neo)adjuvant tx with PD-(L)1 inhibitor allowed
• Germline BRCAm with no other tx option are eligible
• Metastatic tumor sample must be collected ≤3 months prior to consent
• Measurable disease per RECIST v1.1
• No prior tx w/ topo I inhibitor-targeted therapy (incl ADC) nor TROP2-targeted
therapy
Para más información sobre este estudio, PULSE AQUÍ.
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