Not Yet RecruitingPhase 3

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

300 participantsStarted 2026-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Any medications or products including St. John's wort, known to be strong inducers of CYP3A.
✕. Any medications or products known to be strong inhibitors of CYP3A (e.g., grapefruit or grapefruit juice).
✕. Any medications known to be inducers of CYP2A6.
✕. Any medications known to be inhibitors of CYP2A6.

What they're measuring

Progression Free Survival (PFS)

Timeframe: From the date of randomization to the date of the first documented progression or death due to any cause, assessed according to RECIST version 1.1 (up to approximately 30 months).

Trial details

NCT IDNCT07340658

SponsorRovi Pharmaceuticals Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Clinical Operations. Laboratorios Farmacéuticos ROVI

+34 913756230 departamento.medico@rovi.es

View on ClinicalTrials.gov More Advanced, Metastatic Breast Cancer trials