Trial Profile

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 26 Dec 2025

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At a glance

Drugs Patritumab Deruxtecan (Primary) ; Trastuzumab (Primary) ; Trastuzumab-deruxtecan (Primary) ; Tucatinib (Primary)
Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
Focus Adverse reactions
Acronyms HERTHENA-Breast-01
Sponsors Merck Sharp & Dohme

08 Dec 2025 According to a Daiichi Sankyo Company media release, data from this study will be presented at the at the 2025 San Antonio Breast Cancer Symposium (#SABCS25) on December 10 to 12 2025.
30 Oct 2025 Planned End Date changed from 10 Sep 2029 to 18 Apr 2030.
30 Oct 2025 Planned primary completion date changed from 10 Sep 2029 to 18 Apr 2030.

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