A new phase 3 confirmatory trial is underway to assess the use of trastuzumab deruxtecan (T-DXd), a novel HER2-targetedantibody-drug conjugate in patients with HER2-positive, unresectable or metastatic breast cancer, said Ian Krop, MD, PhD, Dana Farber Cancer Institute, Boston, MA.
The anticipated results are important because there is currently no uniform standard of care for patients with HER2-positive breast cancer with disease progression after treatment with ado-trastuzumab emtansine (T-DM1).
T-DXd was designed as an improved antibody-drug conjugate and a topoisomerase I inhibitor, which is rarely used in HER2-positive breast cancers. In phase 1, T-DXd demonstrated promising antitumor activity in patients with HER2-positive breast cancer who had been previously treated with T-DM1. Phase 2 results from the DESTINY-Breast01 study confirmed this. Researchers are currently conducting a phase 3 confirmatory trial—the DESTINY-Breast02 multicenter, open-label study—to compare the safety and efficacy of T-DXd with investigator’s choice of therapy in these patients. The trial began in August 2018, and researchers hope to randomize approximately 600 participants to T-DXd or investigator’s choice (trastuzumab plus capecitabine, or lapatinib plus capecitabine).
These results were shared at SABCS 2019.
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