letrozole SIE / ROVI Pharmaceuticals Laboratories - LARVOL DELTA

SIE-1: 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 (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Rovi Pharmaceuticals Laboratories | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026 ➔ Jun 2026

Enrollment open • Trial initiation date • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

SIE-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 (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Rovi Pharmaceuticals Laboratories | Trial completion date: Jun 2031 ➔ Dec 2033 | Initiation date: May 2026 ➔ Aug 2026

Trial completion date • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

SIE-1: 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 (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Rovi Pharmaceuticals Laboratories

New P1 trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2