Trial comparing treatments for Hormone Receptor Positive Early Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT07401381
What this study is testing
What is US-sourced oral Femara® + Letrozole SIE?
An investigational combination of oral and injectable letrozole being studied for hormone receptor‑positive early breast cancer. is designed to reduce estrogen production by inhibiting aromatase.
Also referred to as Letrozole.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if the quarterly injectable letrozole delivers the same amount of drug into the bloodstream as the daily oral tablet.
- Who it's for
- Post‑menopausal women who have had hormone receptor‑positive early breast cancer and finished at least five years of hormone therapy, including at least two years on letrozole, or four years of therapy if low risk.
- What's involved
- Participants will receive either the quarterly injectable letrozole or the daily oral tablet for several doses, and blood samples will be taken to measure drug levels.
- Time commitment
- The study lasts for the period of multiple doses, with regular clinic visits for injections or pill intake and blood draws.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join 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...
- 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...
You likely can't join 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Beverly Hills, California, United States
- Margate, Florida, United States
- Port Orange, Florida, United States
- Belgrade, Serbia
- Kamenitz, Serbia
- Kragujevac, Serbia
- Niš, Serbia
- Alcorcón, Spain
- Barcelona, Spain
- Granada, Spain
- Jaén, Spain
- León, Spain
- Lleida, Spain
- Manresa, Spain
- Málaga, Spain
- Murcia, Spain
- Pozuelo de Alarcón, Spain
- Reus, Spain
- Sabadell, Spain
- Santiago de Compostela, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beverly Hills, California, United States; Margate, Florida, United States; Port Orange, Florida, United States; Belgrade, Serbia; Kamenitz, Serbia; Kragujevac, Serbia and 14 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.