A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Feb 19, 2027 → Apr 20, 2028
See other at-risk trials from Roche/Genentech

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 19, 2027 to Apr 20, 2028
    • Enrollment closed, study ongoing
    • Trial sites reduced: 352 → 311 locations
    v51
  2. Study sites revised (352)v50
  3. Site details revised at 53 of 352 sitesv49
  4. Study sites revised (352)v48
  5. Study sites: 351 to 352v47
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 351 sitesv46
  2. Study sites revised (351)v45
  3. Study sites revised (351)v44
  4. Site details revised at 1 of 351 sitesv43
  5. Site details revised at 8 of 351 sitesv42
  6. Study sites: 350 to 351v41
  7. Study sites: 348 to 350v40
  8. Primary completion date: Jul 30, 2026 to Feb 19, 2027
    • Study completion date: Dec 30, 2028 to Feb 12, 2029
    • Study sites revised (348)
    v39
  9. Study sites: 346 to 348v38
  10. Study sites: 342 to 346v37
  11. Study sites: 335 to 342v36
  12. Study sites: 332 to 335v35
  13. Study sites: 323 to 332v34
  14. Study sites: 316 to 323v33
  15. Study sites: 310 to 316v32
  16. Study sites: 306 to 310v31
  17. Eligibility criteria revised
    • Site details revised at 1 of 306 sites
    v30
  18. Study sites: 302 to 306
    • Eligibility criteria expanded, about 7 words
    v29
  19. Study sites: 278 to 302v28
  20. Re-verified, no change to tracked fieldsv27
  21. Eligibility criteria expanded, about 22 wordsv26
  22. Study sites: 275 to 278v25
  23. Study sites: 254 to 275v24
  24. Study sites: 251 to 254v23
  25. Study sites: 245 to 251
    • Eligibility criteria expanded, about 16 words
    v22
  26. Study sites: 232 to 245v21
  27. Study sites: 216 to 232v20
  28. Study sites: 194 to 216v19
  29. Study sites: 182 to 194v18
  30. Study sites: 165 to 182v17
  31. Study sites: 145 to 165v16
  32. Study sites: 130 to 145v15
  33. Study sites: 106 to 130v14
  34. Study sites: 86 to 106v13
  35. Study sites: 71 to 86v12
  36. Study sites: 57 to 71v11
  37. Study sites: 48 to 57v10
  38. Study sites: 41 to 48v9
  39. Study sites: 35 to 41v8
  40. Study sites: 33 to 35v7
  41. Study sites: 25 to 33v6
  42. Study sites: 12 to 25v5
  43. Study sites: 4 to 12
    • Start date: Nov 24, 2023 to Dec 11, 2023
    v4
  44. Study sites: 1 to 4v3
  45. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Oct 31, 2023 to Nov 24, 2023
    v2
  • 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.
Roche/Genentech
369 trials monitored
See 29 trials at risk
Breast Cancer
5,481 trials monitored
See 311 trials at risk
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Trial Details
NCT Number NCT06065748
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Enrollment 1,050 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov