USO 22320

Isang Phase III, Open-label, Randomized na Pag-aaral ng Datopotamab Deruxtecan (Dato-DXd) na mayroon o walang Durvalumab kumpara sa Investigator's Choice of Chemotherapy (Paclitaxel/Nab-paclitaxel o Gemcitabine+ Carboplatin) kasama ng Pembrolizumab sa mga Pasyenteng may PD-L1 Positive Paulit-ulit na Inoperable o Metastatic Triple-negative na Kanser sa Suso (TROPIONBreast05)(D7630C00001)

Mga Uri ng Sakit: Pananaliksik sa Kanser sa Suso

Mga Kinakailangan sa Kwalipikasyon:

• 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

Available sa:

• Chesapeake
• Hampton (CarePlex)
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach ( Princess Anne )
• Williamsburg