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A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Trial Profile

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2025

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At a glance

  • Drugs Paclitaxel (Primary) ; Pertuzumab (Primary) ; Trastuzumab (Primary) ; Trastuzumab-deruxtecan (Primary) ; Cyclophosphamide; Doxorubicin
  • Indications Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Breast11
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 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.
  • 06 Nov 2025 According to an AstraZeneca media release, base on results from this trial, the sBLA for ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted by China's NMPA.
  • 18 Oct 2025 According to a Daiichi Sankyo Company media release, results were presented in ESMO and will be published in the Annals of Oncology.

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