Clinical Trial

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)

MOA: Anti-PD-1 monoclonal antibody, Anti-PD-L1 (CD274) monoclonal antibody, Platinum compound, Ribonucleotide reductase inhibitor, Pyrimidine antagonist, TROP-2-targeted ADC, Taxane

Key Eligibility Criteria:

• Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines
• No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
• Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).
• Adequate bone marrow reserve and organ function.
• As judged by investigator, any evidence of diseases which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
• No history of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before Cycle 1 Day 1 and of low potential risk for recurrence.