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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)

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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: 18 Aug 2026

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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

  • 24 Jul 2026 According to a Daiichi Sankyo Company media release, based on DESTINY-Breast11 trial Enhertu (5.4 mg/kg) followed by THP is approved in Singapore as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer.
  • 16 May 2026 Results presented in an AstraZeneca media release.
  • 16 May 2026 According to an AstraZeneca media release, ENHERTU (fam-trastuzumab deruxtecan-nxki) has been approved by the U.S FDA for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 trials, respectively.

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