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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobieta po menopauzie
  • Waga co najmniej 50 kg, wskaźnik BMI między 19 a 39
  • Potwierdzona diagnoza raka piersi wrażliwego na hormony, wczesny stadium
  • Ukończone co najmniej 5 lat terapii hormonalnej, w tym co najmniej 2 lata letrozolem
  • Dobry stan zdrowia ogólny
  • Badanie piersi (mammografia) w ciągu ostatnich 12 miesięcy bez śladów raka

✗ Disqualifies

  • Nieskontrolowana poważna choroba interna
  • Stosowanie hormonów estrogenowych lub progesteronu w ciągu ostatnich 3 miesięcy
  • Zdiagnozowana osteoporoza
  • Choroby serca w przeszłości
  • Pozytywny wynik na wirusowe zapalenie wątroby B lub C, lub HIV

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
80 Years
Last updated (source)
July 24, 2026
Sex
Female only

Therapies / drugs in trial

Locations (1)

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

Murcia, Spain

Trial contact

Clinical Operations. Laboratorios Farmacéuticos ROVI

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/21/2026.

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