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 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).
Conditions studied
Breast Cancer
About this study
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).
Interventions
- 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.
Primary outcomes
- Percentage of Participants With Confirmed Objective Response (cORR) (Up to approximately 2 years)
Eligibility information
Study locations
- Los Angeles Cancer Network - Anaheim, Anaheim, California 92805 United States
- Stanford Cancer Institute, Palo Alto, California 94304 United States
- Cancer Specialists of North Florida, Jacksonville, Florida 32256 United States
- Avera Cancer Institute - Marshall, Marshall, Minnesota 56258 United States
- Avera Cancer Institute - Aberdeen, Aberdeen, South Dakota 57401 United States
- Avera Cancer Institute - Mitchell, Mitchell, South Dakota 57301 United States
- Avera Cancer Institute - Pierre, SD, Pierre, South Dakota 57501 United States
- Avera Cancer Institute, Sioux Falls, South Dakota 57105 United States
- AMG Oncology and Hematology Avera Cancer Institute - Yankton, Yankton, South Dakota 57078 United States
- Medical College of Wisconsin, Milwaukee, Wisconsin 53226 United States
Showing 10 of 58 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.