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
Recruiting · NCT07401381 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
EU sourced oral Femara® + Letrozole SIEUS-sourced oral Femara® + Letrozole SIE
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 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 criteria
- 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 is running
18 locations listed across 2 US states.
- Precision NextGen Oncology and Research Center (Investigational Site number USA-001) - Beverly Hills, California, United States
- D&H National Research Centers INC (Investigational Site number USA-002) - Margate, Florida, United States
- Hospital Universitario Fundación Alcorcón (Investigational Site number ESP-015) - Alcorcón, Spain
- NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona (Investigational Site number ESP-002) - Barcelona, Spain
- Investigational Site number SRB-004 - Belgrade, Serbia
- Investigational Site number SRB-002 - Belgrade, Serbia
- Hospital Universitario Virgen de las Nieves (Investigational Site number ESP-011) - Granada, Spain
- Investigational Site number SRB-001 - Kamenitz, Serbia
- Investigational Site number SRB-003 - Kragujevac, Serbia
- Complejo Asistencial Universitario de León - Hospital de León (Investigational Site number ESP-013) - León, Spain
- Hospital Universitario Arnau de Vilanova de Lleida (Investigational Site number ESP-003) - Lleida, Spain
- Althaia Xarxa Assistencial Universitària de Manresa F.P (Investigational Site number ESP-012) - Manresa, Spain
- Hospital Clínico Universitario Virgen de la Arrixaca (Investigational Site number ESP-009) - Murcia, Spain
- Hospital Quirónsalud Málaga (Investigational Site number ESP-001) - Málaga, Spain
- Investigational Site number SRB-005 - Niš, Serbia
- NEXT Oncology Phase I Unit - Hospital Universitario Quironsalud Madrid (Investigational Site number ESP-008) - Pozuelo de Alarcón, Spain
- Consorci Corporació Sanitària Parc Taulí - Hospital de Sabadell (Investigational Site number ESP-006) - Sabadell, Spain
- Hospital Clinico Universitario Santiago de Compostela (Investigational Site number ESP-007) - Santiago de Compostela, Spain