deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT02258464

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy

Sponsor: Bayer

Conditions Breast Neoplasms
Interventions Background hormonal therapy Placebo (saline) Radium-223 dichloride (Xofigo, BAY88-8223)
Updated 31 times since 2017 Last updated: Jul 29, 2020 Started: Mar 2, 2015 Primary completion: Aug 13, 2019 Completion: Aug 13, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Due to lower than expected recruitment since the start of study

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A PHASE2 clinical study on Breast Neoplasms, this trial is terminated or withdrawn. The trial is conducted by Bayer and has accumulated 31 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Nov 2017 · 3 months · monthly snapshot~Nov 2017 – ~Mar 2018 · 4 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Sep 2020 · 11 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

31 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

▶ Show 26 earlier versions

  1. Sep 2020 — Jan 2021 [monthly]

    Terminated PHASE2

    Status: Completed → Terminated

  2. Oct 2019 — Sep 2020 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

  4. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  6. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2

  7. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

  8. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE2

  9. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE2

  10. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE2

  11. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE2

  12. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE2

  13. Oct 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE2

  14. Sep 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE2

  15. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

  16. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE2

  17. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE2

  18. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  19. Apr 2018 — May 2018 [monthly]

    Active Not Recruiting PHASE2

  20. Mar 2018 — Apr 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  21. Nov 2017 — Mar 2018 [monthly]

    Recruiting PHASE2

  22. Aug 2017 — Nov 2017 [monthly]

    Recruiting PHASE2

  23. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

  24. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  25. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE2

  26. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Mar 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bayer
Data source: Bayer

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

Study Locations

A Coruña, Spain , Aarau, Switzerland , Afula, Israel , Angers, France , Ann Arbor, United States , Annapolis, United States , Aurora, United States , Bakersfield, United States , Barcelona, Spain , Bialystok, Poland and 55 more locations