NCT07405801

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	Inavolisib will be administered as per the schedule mentioned in the protocol.
DRUG	Ribociclib	Ribociclib will be administered as per the schedule mentioned in the protocol.
DRUG	Fulvestrant	Fulvestrant will be administered as per the schedule mentioned in the protocol.
DRUG	Placebo	Placebo will be administered as per the schedule mentioned in the protocol.

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-12-19
• Completion: 2030-02-26
• First posted: 2026-02-12
• Last updated: 2026-04-06

Locations

10 sites across 3 countries: Brazil, Canada, South Korea

Regulatory

• FDA-regulated drug study