Laboratorios Farmacéuticos ROVI S.A. (hereinafter, “ROVI”) announced the enrolment of the first participants in the SIE-11 clinical trial, a study designed the evaluate the comparative bioavailability after multiples doses of Letrozole SIE versus the reference medicine in postmenopausal women with early breast cancer previously treated with endocrine therapy. The first participants were recruited at a Spanish hospital site, marking the effective commencement of the clinical study.
This 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 a significant milestone in the clinical development programme after obtaining the regulatory approvals necessary to conduct the study in Spain, the United States and Serbia. The trial will allow key information to be generated on the pharmacokinetic behaviour of the novel long-acting product compared with the reference oral treatment, helping to define its role in the treatment of hormone-dependent breast cancer.
ROVI plans to continue recruiting patients at the participating centres over coming months in accordance with the clinical development plan established for this investigational medicine.
About the SIE-1 study
Study title: Evaluation of the comparative bioavailability following multiple doses of Letrozole SIE versus Femara®2 in postmenopausal women with early breast cancer previously treated with endocrine therapy.
Protocol No. ROVI: ROV-SIE-2025-02 (ClinicalTrials.gov ID NCT07401381).
Objective: To evaluate the bioavailability, as well as the safety and tolerability, of the investigational product compared with the reference oral medicinal product.
- A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer (SIE-1). ClinicalTrials.gov ID NCT07401381 [https://clinicaltrials.gov/study/NCT07401381]. ↩︎
- Femara® is a medicinal product owned by Novartis Farmacéutica, S.A. ↩︎
