{"id":1515,"date":"2026-07-24T09:10:02","date_gmt":"2026-07-24T09:10:02","guid":{"rendered":"https:\/\/rovi.es\/proyecto-laisolid\/?p=1515"},"modified":"2026-07-24T09:11:55","modified_gmt":"2026-07-24T09:11:55","slug":"rovi-receives-first-regulatory-approvals-for-the-phase-iii-clinical-trial-of-letrozole-sie-for-advanced-or-metastatic-breast-cancer","status":"publish","type":"post","link":"https:\/\/rovi.es\/proyecto-laisolid\/en\/rovi-receives-first-regulatory-approvals-for-the-phase-iii-clinical-trial-of-letrozole-sie-for-advanced-or-metastatic-breast-cancer\/","title":{"rendered":"ROVI receives first regulatory approvals for the phase III clinical trial of Letrozole\u00a0SIE for advanced or metastatic breast cancer\u00a0"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A.\u00a0(hereinafter, \u201cROVI\u201d)\u00a0has announced\u00a0that it has received the first regulatory approvals in the United States, Georgia\u00a0and Serbia\u00a0to conduct the Phase III\u00a0<strong>SIE-3<sup>1<\/sup><\/strong>\u00a0clinical trial, with which it aims to evaluate the safety and efficacy of the investigational product compared with the reference medicine, both\u00a0of which are\u00a0administered in combination with a CDK4\/6 inhibitor, in postmenopausal women with hormone receptor-positive (HR+), HER2 negative (HER2-) locally advanced\u00a0or metastatic\u00a0breast cancer.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This clinical trial forms part of ROVI\u2019s&nbsp;LAISOLID&nbsp;project, funded by the Technological Development and Innovation Centre (CDTI) under Spain\u2019s Recovery, Transformation and Resilience Plan associated to the&nbsp;IPCEI&nbsp;Med4Cure programme.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Letrozole SIE (\u201cSuperior Inhibition of&nbsp;Estrogens\u201d) 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.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The preliminary results of the clinical development programme for Letrozole SIE have allowed&nbsp;progression to the&nbsp;next stages of clinical development. As the company has reported, this programme&nbsp;follows a stepwise development approach that includes clinical studies aimed to characterise the pharmacokinetic, bioavailability,&nbsp;efficacy&nbsp;and safety of the medicine.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The SIE-3 study is a multicentre,&nbsp;randomised,&nbsp;double-blind,&nbsp;double-dummy&nbsp;Phase III study. Its&nbsp;objective&nbsp;is to&nbsp;demonstrate&nbsp;the efficacy and safety of Letrozole SIE compared with oral letrozole, both&nbsp;administered&nbsp;in combination with a CDK4\/6 inhibitor), in patients with HR+\/HER- locally advanced or metastatic breast cancer.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Receiving\u00a0the first regulatory approvals in the United States, Georgia\u00a0and Serbia\u00a0represents\u00a0an important milestone in the development programme and enables ROVI to advance the international launch of the study.\u00a0\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About the\u00a0SIE-3<strong><sup>1<\/sup><\/strong>\u00a0clinical trial<\/strong>\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Study title: <em>A\u00a0Multicenter, Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Safety and Efficacy of Letrozole SIE Compared to\u00a0Femara\u00ae<\/em><sup>2<\/sup><em>\u00a0(combined with a\u00a0CDK4\/6 inhibitor) in Postmenopausal Women with HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cance<\/em>r.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Protocol number&nbsp;ROVI: ROV-SIE-2025-02&nbsp;(ClinicalTrials.gov ID NCT07340658).&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Design:&nbsp;multicentre, randomised, double-blind, double-dummy&nbsp;Phase III clinical trial.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Population:&nbsp;postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Primary&nbsp;objective:&nbsp;to evaluate the efficacy and safety of the investigational product compared with the oral formulation, both combined with a CDK4\/6 inhibitor.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About HR-positive\/HER2 negative breast cancer<\/strong>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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&nbsp;in accordance with&nbsp;routine clinical practice and international treatment&nbsp;guidelines<sup>3<\/sup>.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1255\" height=\"753\" src=\"https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2026\/07\/LOGOS-LAISOLID-1.png\" alt=\"\" class=\"wp-image-1517\" srcset=\"https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2026\/07\/LOGOS-LAISOLID-1.png 1255w, https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2026\/07\/LOGOS-LAISOLID-1-300x180.png 300w, https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2026\/07\/LOGOS-LAISOLID-1-1024x614.png 1024w, https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2026\/07\/LOGOS-LAISOLID-1-768x461.png 768w\" sizes=\"(max-width: 1255px) 100vw, 1255px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><sup>1<\/sup>\u00a0A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared\u00a0With\u00a0Femara\u00ae\u00a0(Both Combined\u00a0With\u00a0the CDK4\/\u200b6 Inhibitor\u00a0Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3).\u00a0ClinicalTrials.gov ID NCT07340658 [https:\/\/clinicaltrials.gov\/study\/NCT07340658].\u00a0\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><sup>2<\/sup>\u00a0Is\u00a0a medicinal\u00a0product\u00a0owned\u00a0by\u00a0Novartis\u00a0Farmac\u00e9utica, S.A.\u00a0\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3 European Society for Medical Oncology (ESMO). Breast cancer guidelines. https:\/\/www.esmo.org\/guidelines\/esmo-clinical-practice-guidelines-breast-cancer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A.\u00a0(hereinafter, \u201cROVI\u201d)\u00a0has announced\u00a0that it has received the first regulatory approvals in the United States, Georgia\u00a0and Serbia\u00a0to conduct the Phase III\u00a0SIE-31\u00a0clinical trial, with which it aims to evaluate the safety and efficacy of the investigational product compared with the reference medicine, both\u00a0of which are\u00a0administered in combination with a CDK4\/6 inhibitor, in postmenopausal women with hormone [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":1516,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21],"tags":[30,35,34,36,33,32,31],"class_list":["post-1515","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-informative-notes","tag-clinical-trial","tag-ipcei","tag-laisolid","tag-med4cure","tag-rd","tag-research","tag-rovi"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ROVI receives first regulatory approvals for the phase III clinical trial of Letrozole\u00a0SIE for advanced or metastatic breast cancer\u00a0 - Proyecto LAISOLID<\/title>\n<meta name=\"description\" content=\"Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A.\u00a0(hereinafter, \u201cROVI\u201d)\u00a0has announced\u00a0that it has received the first regulatory approvals in the 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