deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT05104866

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Sponsor: AstraZeneca

Conditions Breast Cancer
Updated 22 times since 2021 Last updated: Feb 3, 2026 Started: Oct 18, 2021 Primary completion: Jul 24, 2024 Completion: Jul 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Breast Cancer and is currently ongoing. AstraZeneca leads this study, which shows 22 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshot~Jan 2023 – ~Apr 2023 · 3 months · monthly snapshot~Apr 2023 – ~Aug 2023 · 4 months · monthly snapshot~Aug 2023 – ~Nov 2023 · 3 months · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~May 2024 · 2 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~May 2025 · 5 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

22 versions recorded
  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Dec 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  4. May 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE3

Show 17 earlier versions
  1. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  3. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Mar 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

  6. Nov 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  7. Aug 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Apr 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  10. Nov 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  11. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  12. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  13. May 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  14. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  15. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  16. Jan 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  17. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

    First recorded

Oct 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AstraZeneca
  • Daiichi Sankyo
Data source: AstraZeneca

For direct contact, visit the study record on ClinicalTrials.gov .