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A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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Trial Profile

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Feb 2026

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At a glance

  • Drugs Fulvestrant (Primary) ; Inavolisib (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms optINAVO
  • Sponsors Roche

Most Recent Events

  • 23 Feb 2026 Status changed from not yet recruiting to recruiting.
  • 29 Dec 2025 New trial record

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