Clinical Trial

A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer

Study acronym: SIE-3
Not Yet Recruiting Phase 3
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Summary
The purpose of this study is to evaluate the efficacy and safety of Letrozole SIE (injectable) compared to Femara® (oral tablet), both given together with ribociclib, for the first-line treatment of postmenopausal women with HR-positive, HER2-negative, inoperable locally advanced or metastatic breast cancer.
Protocol Amendment History 1 change
minor Completion pushed: 2031-06 -> 2033-12 2026-04-03
Trial Details
NCT Number NCT07340658
Lead Sponsor Rovi Pharmaceuticals Laboratories
Conditions Advanced, Metastatic Breast Cancer
Enrollment 300 participants
Start Date 2026-08
Primary Completion 2029-02 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-02