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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

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Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2025

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At a glance

  • Drugs Anastrozole (Primary) ; Exemestane (Primary) ; Fulvestrant (Primary) ; Inavolisib (Primary) ; Letrozole (Primary) ; Pertuzumab/trastuzumab (Primary) ; Tamoxifen (Primary) ; Taxanes
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms INAVO122
  • Sponsors Roche

Most Recent Events

  • 14 Feb 2025 Planned End Date changed from 28 Jan 2028 to 28 Dec 2032.
  • 14 Feb 2025 Planned primary completion date changed from 30 Oct 2026 to 28 Sep 2026.
  • 28 Nov 2024 Planned End Date changed from 31 Oct 2028 to 28 Jan 2028.

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