Injectable vs Oral Letrozole for Breast Cancer
(SIE-1 Trial)
What You Need to Know Before You Apply
What is the purpose of 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 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.
Are You a Good Fit for This Trial?
This trial is for postmenopausal women with early-stage, hormone receptor-positive breast cancer who have finished at least 4-5 years of hormone therapy (including at least 2 years on letrozole), are in good health, and have recent clear breast imaging. Participants must weigh at least 50 kg and have a BMI between 19 and 39.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Letrozole SIE
- Oral Letrozole (Femara®)
Trial Overview
The study compares how much letrozole gets into the blood when given as a quarterly injection (Letrozole SIE) versus daily oral tablets (Femara®). Both US and EU versions of Femara® are included. The goal is to see if the injectable form works as well as the pill.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rovi Pharmaceuticals Laboratories
Lead Sponsor
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