# 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

Source: https://onco.cc/trials/nct05894239/  
OnCo record `nct05894239` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Inavolisib in HER2-positive breast cancer, run by Hoffmann-La Roche, now recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT05894239 by Hoffmann-La Roche, with 230 participants planned, started 2023-09-08 and due to reach its primary completion in 2026-12-31. Interventions recorded: Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy and Optional Endocrine Therapy of Investigator's Choice.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05894239
- Phase: 3
- Setting: 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
- Sponsor: Hoffmann-La Roche
- Enrolled: 230

## Sources

- ClinicalTrials.gov NCT05894239: https://clinicaltrials.gov/study/NCT05894239

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- drugs: [Inavolisib](https://onco.cc/drugs/inavolisib/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

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