# A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Source: https://onco.cc/trials/nct06790693/  
OnCo record `nct06790693` (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 HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, now recruiting.

## Summary

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT06790693 by Hoffmann-La Roche, with 450 participants planned, started 2025-04-09 and due to reach its primary completion in 2032-01-31. Interventions recorded: Inavolisib, Placebo, CDK4/6i and Letrozole.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06790693
- Phase: 3
- Setting: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
- Sponsor: Hoffmann-La Roche
- Enrolled: 450

## Sources

- ClinicalTrials.gov NCT06790693: https://clinicaltrials.gov/study/NCT06790693

## Connected records

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

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