# A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Source: https://onco.cc/trials/nct05646862/  
OnCo record `nct05646862` (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, Fulvestrant and Alpelisib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, now recruiting.

## Summary

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy is a phase 3 interventional study registered as NCT05646862 by Hoffmann-La Roche, with 420 participants planned, started 2023-06-07 and due to reach its primary completion in 2026-11-13. Interventions recorded: Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole and Midazolam.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05646862
- Phase: 3
- Setting: 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
- Sponsor: Hoffmann-La Roche
- Enrolled: 420

## Sources

- ClinicalTrials.gov NCT05646862: https://clinicaltrials.gov/study/NCT05646862

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Alpelisib](https://onco.cc/drugs/alpelisib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Inavolisib](https://onco.cc/drugs/inavolisib/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

---
JSON: https://onco.cc/api/v1/entities/nct05646862.json