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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 94 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 198 → 203 locations
  2. Trial sites expanded: 192 → 198 locations
  3. Study sites: 198 to 203
  4. Study sites: 192 to 198
  5. Study sites: 191 to 192
  6. Trial sites expanded: 184 → 190 locations
  7. Study sites: 180 to 190 Eligibility criteria expanded, about 65 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 65 words
  8. Study sites: 178 to 180v87
  9. Trial sites expanded: 172 → 175 locationsv86
  10. Trial sites expanded: 165 → 172 locationsv85
  11. Study sites: 172 to 175v84
  12. Study sites: 165 to 172v83
  13. Trial sites expanded: 151 → 165 locationsv82
  14. Study sites: 149 to 151v81
  15. Study sites: 147 to 149v80
  16. Trial sites expanded: 141 → 146 locations Site details revised at 4 of 147 sitesv79 Show 1 more changeShow less
    • Site details revised at 4 of 147 sites
  17. Study sites: 146 to 147v78
  18. Study sites: 141 to 146v77
  19. Study sites: 140 to 141v76
  20. Study sites: 139 to 140v75
  21. Trial sites expanded: 135 → 138 locationsv74
  22. Study sites: 135 to 138v73
  23. Study sites: 134 to 135v72
  24. Trial sites expanded: 129 → 132 locations Start date changed from estimate of Feb 14, 2027 to Aug 10, 2026v71 Show 1 more changeShow less
    • Start date changed from estimate of Feb 14, 2027 to Aug 10, 2026
  25. Trial sites expanded: 125 → 129 locationsv70
  26. Trial sites expanded: 116 → 123 locationsv69
  27. Trial sites expanded: 72 → 116 locationsv68
  28. Study sites: 116 to 123v67
  29. Study sites: 72 to 116v66
  30. Trial sites expanded: 67 → 72 locations Trial sites expanded: 64 → 67 locationsv65 Show 1 more changeShow less
    • Trial sites expanded: 64 → 67 locations
  31. Trial sites expanded: 61 → 64 locationsv64
  32. Study sites: 61 to 64v63
  33. Trial sites expanded: 56 → 59 locationsv62
  34. Trial sites expanded: 40 → 54 locationsv61
  35. Study sites: 54 to 56v60
  36. Trial sites expanded: 36 → 40 locationsv59
  37. Study sites: 36 to 40v58
  38. Trial sites expanded: 28 → 36 locations Trial sites expanded: 25 → 28 locationsv57 Show 1 more changeShow less
    • Trial sites expanded: 25 → 28 locations
  39. Study sites: 25 to 28v56
  40. Study sites: 24 to 25v55
  41. Study sites: 22 to 24v54
  42. Study sites: 21 to 22v53
  43. Study sites: 19 to 21v52
  44. Study sites: 17 to 19v51
  45. Re-verified, no change to tracked fieldsv50
  46. Trial sites expanded: 14 → 18 locationsv49
  47. Study sites: 14 to 18v48
  48. Recruitment opened Start date: Jul 7, 2026 to Feb 14, 2027 · Trial sites expanded: 0 → 14 locationsv47 Show 2 more changesShow less
    • Start date: Jul 7, 2026 to Feb 14, 2027
    • Trial sites expanded: 0 → 14 locations
  49. 2 versions Re-verified since Apr 9, 2026, no change to tracked fieldsv45-v46
  • 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.
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.
Trial Details
NCT Number NCT07391774
Lead Sponsor National Cancer Institute (NCI)
Conditions Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
Enrollment 1,978 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov