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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

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Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

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

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs Inavolisib (Primary) ; Fulvestrant; Palbociclib
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms INAVO120
  • Sponsors Roche

Most Recent Events

  • 31 May 2025 According to a Roche media release, results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).
  • 23 May 2025 According to a Roche media release, based on results form this trial the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Itovebi (inavolisib) for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
  • 23 Apr 2025 According to an pfizer media release, data will be presented 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3 in Chicago.

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