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
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.
- Condition
- Hormone Receptor Positive Early Breast Cancer
- Tested
- US-sourced oral Femara® + Letrozole SIE, EU sourced oral Femara® + Letrozole SIE
- Sponsor
- Rovi Pharmaceuticals Laboratories
Who can join
- Age
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Maximum age: 80 years
- Eligible sex: Female
- Study condition: Hormone Receptor Positive Early Breast Cancer
- 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.
Exclusion 6
- 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
19 sites, 19 recruiting
Investigational Site number SRB-004
Belgrade, Serbia
Investigational Site number SRB-002
Belgrade, Serbia
Investigational Site number SRB-001
Kamenitz, Serbia
Investigational Site number SRB-003
Kragujevac, Serbia
Investigational Site number SRB-005
Niš, Serbia
Hospital Universitario Fundación Alcorcón (Investigational Site number ESP-015)
Alcorcón, Spain
and 13 more sites on ClinicalTrials.gov
Contact
-
Clinical Operations. Laboratorios Farmacéuticos ROVI
+34913756230 departamento.medico@rovi.es
Potential match only. Final eligibility is determined by the study team.