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 t

Trial Details

NCT ID
NCT07401381
Phase
PHASE1
Sponsor
Rovi Pharmaceuticals Laboratories
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • US-sourced oral Femara® + Letrozole SIE
  • EU sourced oral Femara® + Letrozole SIE
Locations (sample)
  • Murcia, Spain|37.98704,-1.13004

Key Eligibility 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 lea…
  • Women in good health.

For full eligibility, visit ClinicalTrials.gov.

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