USO 22320

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab compared with Investigator's Choice of Chemotherapy (Paclitaxel/Nab-paclitaxel or Gemcitabine+ Carboplatin) in combination with Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPIONBreast05)(D7630C00001)

Disease Types: Breast Cancer Research

Eligibility Requirements:

• 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 at:

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