DESTINY-Breast15

About this trial

The antibody-drug conjugate (ADC), Trastuzumab Deruxtecan (T-DXd), commercially available as ENHERTU®, is a HER2 targeted drug that has demonstrated antitumor activity across multiple indications and has received multiple approvals globally, after several studies demonstrating the efficacy of T-DXd in the HER2-low BC population. This is a single-arm, global, multicenter, study of subjects, aged ≥18 with pathologically documented non-resectable advanced or metastatic breast cancer who have received up to two prior lines of therapy in the metastatic setting.
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor [HR]-negative and HR-positive) unresectable and/or metastatic breast cancer. The primary endpoint of interest in this study is time to next treatment (TTNT), a measure that will determine how long T-DXd allows patients to derive clinical benefit from the study drug.

Patient Profile

Patients with unresectable and/or metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer

Where’s this trial being run?

Beaumont Hospital, Cork University Hospital, St James’s Hospital, St Vincents University Hospital, University Hospital Galway, and Mater Misericordiae University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	DESTINY-Breast15
Number:	24-98
Full Title:	A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)

Principal Investigator:	Prof Janice Walshe
Type:	Industry Sponsored
Sponsor:	Daiichi Sankyo Inc.
Recruitment Started:	Global: Dec 2023 Ireland: Jan 2025

Global Recruitment Target:	250
Ireland Recruitment Target:	14