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

Study acronym: TB06
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 130 words Secondary endpoints: details revised at 4 of 7 entries · Site details revised at 1 of 40 sites · Study description expanded, about 4 words Show 3 more changesShow less
    • Secondary endpoints: details revised at 4 of 7 entries
    • Site details revised at 1 of 40 sites
    • Study description expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv9
  3. Eligibility criteria expanded, about 79 words Site details revised at 7 of 40 sitesv8 Show 1 more changeShow less
    • Site details revised at 7 of 40 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 41 to 40v7
  5. Study sites: 40 to 41v6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 11 of 40 sitesv5
  2. Site details revised at 8 of 40 sitesv4
  3. Site details revised at 1 of 40 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 37 to 40 · Start date changed from estimate of Sep 30, 2025 to Oct 30, 2025v2 Show 2 more changesShow less
    • Study sites: 37 to 40
    • Start date changed from estimate of Sep 30, 2025 to Oct 30, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
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.
Trial Details
NCT Number NCT07205822
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions Breast Cancer
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov