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

Phase 3 Not yet recruiting 300 enrolled Rovi Pharmaceuticals Laboratories

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2026-08
Primary completion: 2029-02
Completion: 2033-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letrozole	Other / unclassified	2.5 mg	Other
Background	Ribociclib	Small molecule	—	Oral

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

Summary

Timeline

Drugs

Indications