Clinical Trial

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

Study acronym: SERAFA-1
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.
Protocol Amendment History 5 changes
notable Trial sites expanded: 84 -> 89 locations 2026-08-11
critical Recruitment opened 2026-07-11
notable Trial sites expanded: 80 -> 84 locations 2026-07-11
notable Primary completion pushed: 2028-04-20 -> 2029-02-28 2026-07-11
minor Completion moved earlier: 2034-04-10 -> 2029-02-28 2026-07-11
Trial Details
NCT Number NCT07647328
Lead Sponsor AstraZeneca
Collaborators: ICON plc
Conditions ER-Positive HER2-Negative Breast Cancer
Enrollment 150 participants
Start Date 2026-06-15
Primary Completion 2029-02-28 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-10