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
NCT05646862
This study is recruiting at 2 US sites in 2 states, according to its ClinicalTrials.gov record last updated .
Summary
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Hoffmann-La Roche
- Last updated on ClinicalTrials.gov
- September 28, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Georgia · 1
- Emory University Hospital · Atlanta, GA
Massachusetts · 1
- Massachusetts General Hospital · Boston, MA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.