clinical trial · NCT05894239
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Hoffmann-La Roche·phase3·recruiting·n = 230
Metastatic Breast CancerInavolisibPhesgoPlaceboTaxane-based ChemotherapyOptional Endocrine Therapy of Investigator's Choice
brief summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
started
Sep 8, 2023
primary completion
Dec 31, 2026
completion
Dec 28, 2032
last updated
Mar 31, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol