OncRef

Clinical Trial: NCT04739761

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-08-11

Study Overview

Brief Summary

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

Official Title

An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Trastuzumab Deruxtecan

Other Study ID Numbers

  • D9673C00007
  • 2024-510588-53-00
  • 2020-005048-46

Start Date (Actual)

2021-06-22

Primary Completion Date (Actual)

2024-02-08

Study Completion Date (Estimated)

2027-05-26

Enrollment (Actual)

506

Study Type

Interventional

Phase

Phase 3