# A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

Source: https://onco.cc/trials/nct07405801/  
OnCo record `nct07405801` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Inavolisib, Ribociclib and Fulvestrant in advanced solid tumours, run by Hoffmann-La Roche, now recruiting.

## Summary

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer is a phase 2 interventional study registered as NCT07405801 by Hoffmann-La Roche, with 80 participants planned, started 2026-04-07 and due to reach its primary completion in 2028-12-19. Interventions recorded: Inavolisib, Ribociclib, Fulvestrant and Placebo.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07405801
- Phase: 2
- Setting: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation
- Sponsor: Hoffmann-La Roche
- Enrolled: 80

## Sources

- ClinicalTrials.gov NCT07405801: https://clinicaltrials.gov/study/NCT07405801

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- drugs: [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Inavolisib](https://onco.cc/drugs/inavolisib/), [Ribociclib](https://onco.cc/drugs/ribociclib/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

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JSON: https://onco.cc/api/v1/entities/nct07405801.json