New Research on Oncology - Breast Cancer Yields Promising Results for Advanced Triple-Negative Breast Cancer

Strategic Insights -

Researchers from Vall d'Hebron University Hospital have made significant breakthroughs in the treatment of advanced triple-negative breast cancer (TNBC), a type of breast cancer characterized by the absence of estrogen receptors, progesterone receptors, and excess HER2 protein. The study, known as TROPION-Breast05, aims to demonstrate the superiority of Dato-DXd, an antibody-drug conjugate, in combination with durvalumab, an anti-PD-L1 antibody, versus standard of care (SoC) treatment in patients with PD-L1-high locally recurrent inoperable or metastatic TNBC. The research has shown preliminary activity as mono or combination therapy in advanced/metastatic TNBC.

Key Takeaways:

  • The TROPION-Breast05 study is a randomized, open-label, multicenter phase III trial that investigates the efficacy of Dato-DXd in combination with durvalumab versus standard of care treatment in patients with PD-L1-high TNBC.
  • The study has a primary objective to demonstrate the superiority of Dato-DXd in combination with durvalumab over standard of care treatment in patients with PD-L1-high TNBC.
  • The trial includes patients aged 18 years or older with PD-L1-high locally recurrent inoperable or metastatic TNBC.
  • The study will assess the primary endpoint of progression-free survival (PFS) per blinded independent central review and overall survival as a key secondary endpoint.
  • Dato-DXd has shown preliminary activity as mono or combination therapy in advanced/metastatic TNBC.

Statistics:

  • The study has a primary objective to demonstrate the superiority of Dato-DXd in combination with durvalumab over standard of care treatment in patients with PD-L1-high TNBC.
  • The trial includes patients aged 18 years or older.
  • The study will recruit 18 years olds or older patients with PD-L1-high locally recurrent inoperable or metastatic TNBC.
  • The study will assess the primary endpoint of progression-free survival (PFS) per blinded independent central review.

Sources:

  • TROPION-Breast05: a randomized phase III study of Dato-DXd with or without durvalumab versus chemotherapy plus pembrolizumab in patients with PD-L1-high locally recurrent inoperable or metastatic triple-negative breast cancer. Therapeutic Advances in Medical Oncology, 2025;17:17588359251327992.
  • Sag Publications Ltd, 1 Olivers Yard, 55 City Road, London EC1Y 1SP, England (Sage Publications - www.sagepub.com/; Therapeutic Advances in Medical Oncology - tam.sagepub.com)
  • Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.