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A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

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Trial Profile

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 May 2026

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At a glance

  • Drugs Fulvestrant (Primary) ; Inavolisib (Primary) ; Alpelisib; Metformin
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms INAVO121
  • Sponsors Roche

Most Recent Events

  • 06 May 2026 Planned primary completion date changed from 6 Apr 2026 to 13 Nov 2026.
  • 05 Feb 2026 Planned primary completion date changed from 30 Jun 2026 to 6 Apr 2026.
  • 05 Nov 2025 Number of treatment arms are increased from 2 to 3 by the addition of Experimental: Sub-study: Inavolisib + Fulvestrant + CYP substrates arm. Planned enrollment increased and additional primary end-points for the sub-study are also added.

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