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A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later across 2 updates Oct 31, 2027 → Jun 15, 2028
See other at-risk trials from Roche/Genentech

Record History

The 50 most recent of 55 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2027 to Jun 15, 2028
    • Primary completion pushed from Oct 31, 2027 to Dec 31, 2027
    • Trial sites reduced: 202 → 198 locations
  2. Study sites: 202 to 198 Show 4 more changesShow less
    • Primary completion date: Oct 31, 2027 to Dec 31, 2027
    • Interventions: Docetaxel (Drug), Giredestrant (Drug), LHRH Agonist (Drug), Optional Endocrine Therapy of Investigator's Choice (Drug), Paclitaxel (Drug)… to Docetaxel (Drug), Giredestrant (Drug), LHRH Agonist (Drug), Optional Endocrine Therapy of Investigator's Choice (Drug), Paclitaxel (Drug)…
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 3 of 12 entries
  3. Trial sites reduced: 206 → 202 locationsv53
  4. Study sites: 208 to 206v52
  5. Study sites: 209 to 208v51
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 237 to 209
    • Primary completion date: Dec 31, 2027 to Oct 31, 2027
    v50
  2. Re-verified, no change to tracked fieldsv49
  3. Site details revised at 10 of 237 sitesv48
  4. Site details revised at 2 of 237 sitesv47
  5. Site details revised at 5 of 237 sitesv46
  6. Site details revised at 17 of 237 sitesv45
  7. Site details revised at 1 of 237 sitesv44
  8. Site details revised at 26 of 237 sitesv43
  9. Site details revised at 1 of 237 sitesv42
  10. Primary completion date: Mar 31, 2027 to Dec 31, 2027
    • Study sites: 233 to 237
    • Start date: Jul 4, 2022 to Jul 18, 2022
    v41
  11. Enrollment target: 812 to 922
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 12 of 12 entries
    v40
  12. Study sites: 230 to 233v39
  13. Primary completion date: Aug 31, 2026 to Mar 31, 2027
    • Study completion date: Sep 30, 2032 to Dec 31, 2030
    v38
  14. Re-verified, no change to tracked fieldsv37
  15. Site details revised at 8 of 230 sitesv36
  16. Study sites: 224 to 230v35
  17. Study sites: 219 to 224v34
  18. Study sites: 215 to 219v33
  19. Study sites: 212 to 215v32
  20. Study sites: 206 to 212v31
  21. Study sites: 199 to 206v30
  22. Study sites: 197 to 199v29
  23. Study sites: 196 to 197v28
  24. Study sites: 192 to 196v27
  25. Study sites: 189 to 192v26
  26. Study sites: 188 to 189v25
  27. Study sites: 185 to 188v24
  28. Study sites: 182 to 185v23
  29. Study sites: 180 to 182v22
  30. Study sites: 178 to 180v21
  31. Study sites: 177 to 178
    • Eligibility criteria expanded, about 58 words
    v20
  32. Study sites: 173 to 177v19
  33. Study sites: 169 to 173v18
  34. Study sites: 166 to 169v17
  35. Study sites: 165 to 166v16
  36. Study sites: 162 to 165v15
  37. Study sites: 151 to 162v14
  38. Study sites: 138 to 151v13
  39. Study sites: 119 to 138v12
  40. Study sites: 103 to 119v11
  41. Study sites: 92 to 103v10
  42. Study sites: 80 to 92v9
  43. Study sites: 61 to 80v8
  44. Study sites: 53 to 61v7
  45. Study sites: 22 to 53
    • Start date: Jul 18, 2022 to Jul 4, 2022
    v6
  • 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.
Roche/Genentech
367 trials monitored
See 31 trials at risk
Breast Cancer
5,428 trials monitored
See 303 trials at risk
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.
Trial Details
NCT Number NCT05296798
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Locally Advanced or Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 922 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov