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

Recruiting Phase 1 Interventional Study
Hormone Receptor Positive Early Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Rovi Pharmaceuticals Laboratories · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Women with weight of ≥50 kg and a Body Mass Index (BMI) ≥19 kg/m2 and ≤39 kg/m2 * Postmenopausal women. * Women with confirmed diagnosis of HR+/HER2- or HR+/HER2+ early stage breast cancer who have completed at least 5 years of endocrine therapy, at least 2 years of which were…
Contacts

Clinical Operations. Laboratorios Farmacéuticos ROVI

+34913756230

departamento.medico@rovi.es

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