Clinical Trial

A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer

Study acronym: TB06
Recruiting Phase 3
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Summary
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-09-26; most recent amendment 2026-07-24.
Status change: Not Yet Recruiting → Recruiting 2025-11-21
Trial Details
NCT Number NCT07205822
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions Breast Cancer
Enrollment 100 participants
Start Date 2025-10-30
Primary Completion 2028-02-02 (estimated)
Study Completion 2028-02-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-27