Daiichi Sankyo Company has dosed the first patient in the Phase III DESTINY-Breast04 trial that aims to investigate [fam-] trastuzumab deruxtecan for the treatment of patients with HER2 low, unresectable and / or metastatic breast cancer previously treated with one to two prior lines of chemotherapy.

The trial is designed to compare [fam-] trastuzumab deruxtecan with the investigator’s choice of chemotherapies including capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel.

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The global, randomised, active-controlled study intends to include up to 540 patients at around 160 sites in North America, Western Europe, Asia, and other regions.

Primary efficacy objective of the open-label, multicentre, two-arm trial is progression-free survival based on a blinded independent central review.

“DESTINY-Breast04 has been initiated based on preliminary Phase I study results to determine whether [fam-] trastuzumab deruxtecan could serve as a targeted therapy option.”

The trial’s safety objectives comprise serious adverse events, treatment-emergent adverse events and adverse events of special interest.

Its secondary efficacy goals are progression-free survival based on investigator assessment, overall survival, objective response rate and duration of response.

Daiichi Sankyo Oncology Research and Development DS-8201 Global Team Leader vice-president Gilles Gallant said: “DESTINY-Breast04 has been initiated based on preliminary Phase I study results to determine whether [fam-] trastuzumab deruxtecan could serve as a targeted therapy option for patients with HER2 low metastatic breast cancer that progresses after standard chemotherapy, regardless of HR status.

“HER2 targeting agents have improved survival rates for HER2 positive breast cancer, but none have been approved in HER2 low expressing tutors.

“DESTINY-Breast04, our third Phase III breast cancer trial with [fam-] trastuzumab deruxtecan, has potential to define a new patient population for HER2 targeted treatment.”

[Fam-] trastuzumab deruxtecan contains a humanised HER2 antibody attached to a new topoisomerase I inhibitor payload by a tetrapeptide-based linker.