Laboratorios Farmacéuticos ROVI S.A. (hereinafter, “ROVI”) has announced the enrolment of the first participants in the SIE[1] clinical trial, which is intended to evaluate the safety and efficacy of the investigational product in comparison with the reference medicine, both of which are administered in combination with a CDK4/6 inhibitor, in postmenopausal women with hormone receptor-positive (HR+), HER2 negative (HER2-) locally advanced or metastatic breast cancer. The first participants were recruited at a hospital site in Georgia, marking the initiation of the clinical trial.
The SIE-3 clinical trial forms part of ROVI’s LAISOLID project, funded by the Technological Development and Innovation Centre (CDTI) under Spain’s Recovery, Transformation and Resilience Plan associated to the IPCEI Med4Cure programme.
Letrozole SIE (“Superior Inhibition of Estrogens”) is an investigational medicine that ROVI is developing to treat postmenopausal women with hormone receptor-positive breast cancer. It is a long-acting injectable (LAI) formulation designed to obtain sustained and stable oestrogen suppression for several months, which could have a positive impact on disease progression.
The enrolment of the first participant marks an important milestone in the clinical development programme after obtaining the regulatory authorisations required to conduct the study
ROVI plans to continue recruiting the patients at the participating sites over the coming months, in accordance with the clinical development plan established for this investigational medicine.
About the SIE-3 study
Study title: A Multicenter, Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Safety and Efficacy of Letrozole SIE Compared to Femara®[2] (combined with a CDK4/6 inhibitor) in Postmenopausal Women with HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer.
Protocol number ROVI: ROV-SIE-2025-02 (ClinicalTrials.gov ID NCT07340658).
Population: postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer.
Design: multicentre, randomised, double-blind, double-dummy Phase III clinical trial.
Primary objective: to evaluate the efficacy and safety of the investigational product compared with the oral formulation, both combined with a CDK4/6 inhibitor.
About HR-positive/HER2 negative breast cancer HR-positive/HER2-negative breast cancer is the most frequent subtype of breast cancer. In postmenopausal women with locally advanced or metastatic disease, endocrine therapy is one of the cornerstones of treatment and can be administered in combination with CDK4/6 inhibitors in accordance with routine clinical practice and international treatment guidelines.[3]
[1] 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 (SIE-3). ClinicalTrials.gov ID NCT07340658 [https://clinicaltrials.gov/study/NCT07340658].
[2] Novartis Farmacéutica S.A. is the owner of this medicine.
[3] European Society for Medical Oncology (ESMO). Breast cancer guidelines. [https://www.esmo.org/guidelines/esmo-clinical-practice-guidelines-breast-cancer]
