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
Eligible age
18–80 yrs
Accepts
Women
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Rovi Pharmaceuticals Laboratories
You may qualify if…
- ✓ 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 with letrozole. Participants at a low risk of relapse, as assessed by the investigator, can also be eligible after completing 4 years of adjuvant endocrine therapy, at least 2 of which were with letrozole.
- ✓ Women in good health.
- ✓ Women who have undergone breast imaging per applicable guidelines (e.g., mammogram) within the last 12 months with no evidence of malignancy (documentation required), and if not done, must be willing to have 1 performed prior to baseline.
You may not qualify if…
- ✕ Presence of an uncontrolled, unstable, clinically significant medical condition.
- ✕ Have used estrogen or progesterone systemic or topical therapy, oral contraceptives, androgens, LH-releasing hormone analogs, prolactin inhibitors, or antiandrogens within 3 months prior to screening.
- ✕ Use of inducers or inhibitors of CYP3A4 and CYP2A6.
- ✕ Diagnosed with osteoporosis.
- ✕ Preexisting cardiovascular disease
- ✕ Positive result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibodies.
Where it's recruiting
Beverly Hills
Margate · Port Orange
Source: ClinicalTrials.gov · NCT07401381 · last updated 2026-09-23