{"id":1528,"date":"2026-07-28T16:07:12","date_gmt":"2026-07-28T16:07:12","guid":{"rendered":"https:\/\/rovi.es\/proyecto-laisolid\/?p=1528"},"modified":"2026-07-28T16:08:05","modified_gmt":"2026-07-28T16:08:05","slug":"rovi-initiates-the-sie-1-clinical-trial-with-the-enrolment-of-the-first-participants-in-spain-as-part-of-the-clinical-development-of-a-new-quarterly-letrozole-formulation-letrozole-sie","status":"publish","type":"post","link":"https:\/\/rovi.es\/proyecto-laisolid\/en\/rovi-initiates-the-sie-1-clinical-trial-with-the-enrolment-of-the-first-participants-in-spain-as-part-of-the-clinical-development-of-a-new-quarterly-letrozole-formulation-letrozole-sie\/","title":{"rendered":"ROVI initiates the SIE-1 clinical trial with the enrolment of the first participants in Spain as part of the clinical development of a new quarterly letrozole formulation (Letrozole SIE)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A. (hereinafter,\u00a0\u201cROVI\u201d)\u00a0announced the enrolment of the first participants in the\u00a0<strong>SIE-1<\/strong><sup data-fn=\"46b75285-d10d-4099-8311-01f8c4f4b1f2\" class=\"fn\"><a href=\"#46b75285-d10d-4099-8311-01f8c4f4b1f2\" id=\"46b75285-d10d-4099-8311-01f8c4f4b1f2-link\">1<\/a><\/sup><strong>\u00a0<\/strong>clinical trial, a study designed the evaluate the comparative bioavailability after multiples doses of\u00a0<strong>Letrozole SIE<\/strong>\u00a0versus\u00a0the reference\u00a0medicine\u00a0in postmenopausal women with early breast cancer\u00a0previously\u00a0treated with endocrine therapy. The first participants were recruited\u00a0at\u00a0a Spanish hospital\u00a0site, marking the effective\u00a0commencement\u00a0of the clinical study.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This clinical trial&nbsp;forms part of&nbsp;ROVI\u2019s LAISOLID project, funded by the Technological Development and Innovation Centre (CDTI)&nbsp;under&nbsp;Spain\u2019s&nbsp;Recovery, Transformation and Resilience Plan associated to the IPCEI Med4Cure programme.&nbsp;<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"857\" height=\"71\" src=\"https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2025\/12\/unnamed-1.png\" alt=\"\" class=\"wp-image-1329\" srcset=\"https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2025\/12\/unnamed-1.png 857w, https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2025\/12\/unnamed-1-300x25.png 300w, https:\/\/rovi.es\/proyecto-laisolid\/wp-content\/uploads\/2025\/12\/unnamed-1-768x64.png 768w\" sizes=\"(max-width: 857px) 100vw, 857px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Letrozole SIE (\u201cSuperior&nbsp;Inhibition of&nbsp;Estrogens\u201d) is an&nbsp;investigational medicine that ROVI is developing to treat postmenopausal women with hormone&nbsp;receptor-positive breast cancer. It is a long-acting injectable (LAI)&nbsp;formulation&nbsp;designed to obtain&nbsp;sustained&nbsp;and stable&nbsp;oestrogen suppression&nbsp;for several months, which could have a positive impact on&nbsp;disease&nbsp;progression.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The enrolment of the first participant&nbsp;marks&nbsp;a significant milestone in the clinical development programme after obtaining the regulatory&nbsp;approvals&nbsp;necessary to conduct the study in Spain, the United States and Serbia. The trial will allow key information to be generated&nbsp;on&nbsp;the&nbsp;pharmacokinetic behaviour of the&nbsp;novel&nbsp;long-acting&nbsp;product&nbsp;compared with&nbsp;the reference oral treatment,&nbsp;helping&nbsp;to define its role in the treatment of hormone-dependent breast cancer.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ROVI plans to continue recruiting patients at the participating centres over coming months&nbsp;in accordance with&nbsp;the clinical development plan&nbsp;established&nbsp;for this investigational medicine.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About the SIE-1 study<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Study title: <em>Evaluation of the comparative bioavailability following multiple doses of Letrozole SIE versus Femara\u00ae<\/em><sup data-fn=\"1beaa055-0616-44be-94d4-a91f574a30f5\" class=\"fn\"><a href=\"#1beaa055-0616-44be-94d4-a91f574a30f5\" id=\"1beaa055-0616-44be-94d4-a91f574a30f5-link\">2<\/a><\/sup><em> in postmenopausal women with early breast cancer previously treated with endocrine therapy.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Protocol No. ROVI: ROV-SIE-2025-02 (ClinicalTrials.gov ID NCT07401381).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Objective: To evaluate the bioavailability, as well as the safety and tolerability, of the investigational product compared with the reference oral medicinal product.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<ol class=\"wp-block-footnotes\"><li id=\"46b75285-d10d-4099-8311-01f8c4f4b1f2\"><em>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)<\/em>. ClinicalTrials.gov ID NCT07401381 [<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07401381\">https:\/\/clinicaltrials.gov\/study\/NCT07401381<\/a>]. <a href=\"#46b75285-d10d-4099-8311-01f8c4f4b1f2-link\" aria-label=\"Jump to footnote reference 1\">\u21a9\ufe0e<\/a><\/li><li id=\"1beaa055-0616-44be-94d4-a91f574a30f5\">\u00a0Femara\u00ae is a medicinal product owned by Novartis Farmac\u00e9utica, S.A. <a href=\"#1beaa055-0616-44be-94d4-a91f574a30f5-link\" aria-label=\"Jump to footnote reference 2\">\u21a9\ufe0e<\/a><\/li><\/ol>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A. (hereinafter,\u00a0\u201cROVI\u201d)\u00a0announced the enrolment of the first participants in the\u00a0SIE-1\u00a0clinical trial, a study designed the evaluate the comparative bioavailability after multiples doses of\u00a0Letrozole SIE\u00a0versus\u00a0the reference\u00a0medicine\u00a0in postmenopausal women with early breast cancer\u00a0previously\u00a0treated with endocrine therapy. The first participants were recruited\u00a0at\u00a0a Spanish hospital\u00a0site, marking the effective\u00a0commencement\u00a0of the clinical study.\u00a0 This clinical trial&nbsp;forms part of&nbsp;ROVI\u2019s LAISOLID project, [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":1530,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"[{\"id\":\"46b75285-d10d-4099-8311-01f8c4f4b1f2\",\"content\":\"<em>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)<\\\/em>. ClinicalTrials.gov ID NCT07401381 [<a href=\\\"https:\\\/\\\/clinicaltrials.gov\\\/study\\\/NCT07401381\\\">https:\\\/\\\/clinicaltrials.gov\\\/study\\\/NCT07401381<\\\/a>].\"},{\"id\":\"1beaa055-0616-44be-94d4-a91f574a30f5\",\"content\":\"\\u00a0Femara\\u00ae is a medicinal product owned by Novartis Farmac\\u00e9utica, S.A.\"}]"},"categories":[21],"tags":[30,35,34,36,33,32,31],"class_list":["post-1528","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 initiates the SIE-1 clinical trial with the enrolment of the first participants in Spain as part of the clinical development of a new quarterly letrozole formulation (Letrozole SIE) - Proyecto LAISOLID<\/title>\n<meta name=\"description\" content=\"Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A. (hereinafter,\u00a0\u201cROVI\u201d)\u00a0announced the enrolment of the first participants in the\u00a0SIE-11\u00a0clinical trial, a study\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/rovi.es\/proyecto-laisolid\/en\/rovi-initiates-the-sie-1-clinical-trial-with-the-enrolment-of-the-first-participants-in-spain-as-part-of-the-clinical-development-of-a-new-quarterly-letrozole-formulation-letrozole-sie\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ROVI initiates the SIE-1 clinical trial with the enrolment of the first participants in Spain as part of the clinical development of a new quarterly letrozole formulation (Letrozole SIE) - Proyecto LAISOLID\" \/>\n<meta property=\"og:description\" content=\"Laboratorios\u00a0Farmac\u00e9uticos\u00a0ROVI S.A. 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