A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Study acronym: INAVO122
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Site details revised at 11 of 192 sites
  2. Interventions: Inavolisib (Drug), Optional Endocrine Therapy of Investigator's Choice (Drug), Phesgo (Drug), Placebo (Drug), Taxane-based Chemotherapy… to Inavolisib (Drug), Optional Endocrine Therapy of Investigator's Choice (Drug), Phesgo (Drug), Placebo (Drug), Taxane-based Chemotherapy…
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Site details revised at 18 of 192 sites
  3. Study sites revised (192)v43
  4. Site details revised at 13 of 192 sitesv42
  5. Site details revised at 14 of 192 sitesv41
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 27 of 192 sitesv40
  2. Study sites: 190 to 192v39
  1. Primary completion pushed from Sep 28, 2026 to Dec 31, 2026
    • Trial sites expanded: 187 → 190 locations
    v38
  2. Study sites: 184 to 187v37
  3. Study sites: 182 to 184v36
  4. Study sites: 181 to 182v35
  5. Study sites: 180 to 181v34
  6. Study sites: 177 to 180v33
  7. Site details revised at 4 of 177 sitesv32
  8. Study sites: 175 to 177v31
  9. Study sites: 173 to 175v30
  10. Study sites: 169 to 173v29
  11. Study sites: 164 to 169v28
  12. Study sites: 163 to 164v27
  13. Start date: Jul 28, 2023 to Sep 8, 2023
    • Study sites: 161 to 163
    v26
  14. Study sites: 158 to 161v25
  15. Study sites: 154 to 158
    • Primary completion date: Oct 30, 2026 to Sep 28, 2026
    • Study completion date: Jan 28, 2028 to Dec 28, 2032
    v24
  16. Study sites: 155 to 154v23
  17. Primary completion date: Oct 31, 2028 to Oct 30, 2026
    • Study sites: 151 to 155
    • Study completion date: Oct 31, 2028 to Jan 28, 2028
    v22
  18. Re-verified, no change to tracked fieldsv21
  19. Study sites: 145 to 151v20
  20. Study sites: 141 to 145v19
  21. Study sites: 135 to 141v18
  22. Study sites: 132 to 135v17
  23. Study sites: 123 to 132v16
  24. Study sites: 103 to 123v15
  25. Study sites: 96 to 103v14
  26. Study sites: 83 to 96v13
  27. Study sites: 71 to 83
    • Eligibility criteria expanded, about 5 words
    v12
  28. Study sites: 66 to 71v11
  29. Study sites: 63 to 66v10
  30. Study sites: 56 to 63v9
  31. Study sites: 46 to 56v8
  32. Study sites: 35 to 46v7
  33. Study sites: 17 to 35
    • Start date changed from estimate of Aug 31, 2023 to Jul 28, 2023
    v6
  34. Study sites: 8 to 17v5
  35. Start date: Jul 1, 2023 to Aug 31, 2023
    • Study sites: 2 to 8
    v4
  36. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date: Jul 30, 2023 to Jul 1, 2023
    v3
  37. Start date: May 31, 2023 to Jul 30, 2023
    • Study title shortened, about 12 words
    v2
  38. Study First Submitted
  • 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
371 trials monitored
See 27 trials at risk
Breast Cancer
5,486 trials monitored
See 312 trials at risk
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Trial Details
NCT Number NCT05894239
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov