deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 2-arm NCT04090398

Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones

Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Anatomic Stage IV Breast Cancer AJCC v8 Metastatic HER2-Negative Breast Carcinoma Metastatic Malignant Neoplasm in the Bone
Interventions Biospecimen Collection Bone Scan Computed Tomography Electronic Health Record Review Magnetic Resonance Imaging Paclitaxel Radium Ra 223 Dichloride Single Photon Emission Computed Tomography
Updated 58 times since 2019 Last updated: Mar 12, 2026 Started: Aug 4, 2020 Primary completion: Jun 30, 2026 Completion: Jun 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic HER2-Negative Breast Carcinoma and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 58 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Jul 2025 · 5 months · monthly snapshot~Jul 2025 – ~Oct 2025 · 3 months · monthly snapshot~Oct 2025 – ~Jan 2026 · 3 months · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 4 months · monthly snapshot

Change History

58 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE2

  2. Feb 2026 — Mar 2026 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting PHASE2

  4. Oct 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2

▶ Show 53 earlier versions

  1. Feb 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE2

  2. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE2

  3. Nov 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  7. Apr 2024 — Jun 2024 [monthly]

    Recruiting PHASE2

  8. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE2

  9. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE2

  10. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE2

  11. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

  12. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE2

  13. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE2

  14. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE2

  15. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE2

  16. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE2

  17. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE2

  18. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE2

  19. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE2

  20. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE2

  21. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE2

  22. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

  23. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE2

  24. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  25. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  26. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE2

  27. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  28. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  29. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE2

  30. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE2

  31. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  32. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  33. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  34. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

  35. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  36. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  37. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  38. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  39. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  40. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  41. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  42. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

  43. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

  44. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

  45. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

  46. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  47. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE2

  48. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE2

  49. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  50. Jan 2020 — Apr 2020 [monthly]

    Not Yet Recruiting PHASE2

  51. Dec 2019 — Jan 2020 [monthly]

    Not Yet Recruiting PHASE2

  52. Nov 2019 — Dec 2019 [monthly]

    Not Yet Recruiting PHASE2

  53. Oct 2019 — Nov 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations

Birmingham, United States , Charlottesville, United States , Chicago, United States , Columbus, United States , Coral Gables, United States , Deerfield Beach, United States , Detroit, United States , Duarte, United States , Fairway, United States , Farmington Hills, United States and 18 more locations