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

The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole (Femara®), in women who have gone through menopause and have received treatment for hormone receptor-positive early breast cancer. Participants must have completed at least five years of hormone therapy with at least two of those years with letrozole before starting their participation in the study. Women who have completed four years of hormone therapy are also eligible if their doctor considers them at low risk of cancer returning.

NCT Number	NCT07401381
Lead Sponsor	Rovi Pharmaceuticals Laboratories
Conditions	Hormone Receptor Positive Early Breast Cancer
Enrollment	120 participants
Start Date	2026-06-08
Primary Completion	2028-05 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2026-07-24