A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Study acronym: INAVO123
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 241 to 242
    • Interventions: CDK4/6i (Drug), Inavolisib (Drug), Letrozole (Drug), Placebo (Drug) to CDK4/6i (Drug), Inavolisib (Drug), Letrozole (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 13 entries
  2. Primary completion moved earlier from May 30, 2032 to Jan 31, 2032
    • Study completion moved earlier from May 30, 2032 to Feb 1, 2032
    • Study sites: 239 to 241
    v18
  3. Trial sites expanded: 232 → 239 locationsv17
  4. Trial sites expanded: 227 → 232 locationsv16
  5. Study sites: 226 to 227v15
  6. Trial sites expanded: 219 → 226 locationsv14
  7. Trial sites expanded: 210 → 219 locationsv13
  8. Study sites: 204 to 210v12
  9. Study sites: 194 to 204v11
  10. Study sites: 189 to 194v10
  11. Study sites: 176 to 189v9
  12. Primary completion date: Jan 29, 2028 to May 30, 2032
    • Study sites: 154 to 176
    v8
  13. Study sites: 133 to 154v7
  14. Study sites: 117 to 133v6
  15. Study sites: 80 to 117v5
  16. Study sites: 64 to 80v4
  17. Study sites: 48 to 64v3
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 48
    • Start date changed from estimate of Feb 28, 2025 to Apr 9, 2025
    v2
  19. 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
369 trials monitored
See 29 trials at risk
Breast Cancer
5,481 trials monitored
See 311 trials at risk
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
Trial Details
NCT Number NCT06790693
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov