RecruitingPhase 1NCT07401381

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

An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Quarterly Letrozole SIE and Once Daily 2.5 mg Oral Letrozole (Femara®) in Post-Menopausal Women Treated With Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer. (SIE-1)


Sponsor

Rovi Pharmaceuticals Laboratories

Enrollment

120 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EU sourced oral Femara® + Letrozole SIE and a drug called US-sourced oral Femara® + Letrozole SIE for people with hormone receptor positive early breast cancer. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUS-sourced oral Femara® + Letrozole SIE

US-sourced Femara® 2.5 mg/day oral for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)

DRUGEU sourced oral Femara® + Letrozole SIE

EU-sourced oral Femara® 2.5 mg/day for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)


Locations(1)

Hospital Clínico Universitario Virgen de la Arrixaca (Investigational Site number ESP-009)

Murcia, Spain

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NCT07401381