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Hormone Receptor Positive Early Breast Cancer / EU sourced oral Femara® + Letrozole SIE / US-sourced oral Femara® + Letrozole SIE · Phase 1 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration comparing steady-state bioavailability of a quarterly injectable letrozole formulation (SIE) versus oral letrozole (Femara®) in post-menopausal women with hormone receptor-positive early breast cancer. No results have been posted to the registry; the study is currently recruiting and designed to measure area under the concentration-time curve at steady state as the primary endpoint.
Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Hormone Receptor Positive Early Breast Cancer; Female; age from 18 Years; to 80 Years. Intervention: US-sourced oral Femara®; EU-sourced oral Femara®. Compared with: Injectable Letrozole SIE versus oral Femara® (letrozole); comparison between US-sourced and EU-sourced oral formulations also planned.. n = 120. 18 sites: United States, Serbia, Spain.
This is a Phase 1 clinical trial registration comparing steady-state bioavailability of a quarterly injectable letrozole formulation (SIE) versus oral letrozole (Femara®) in post-menopausal women with hormone receptor-positive early breast cancer. No results have been posted to the registry; the study is currently recruiting and designed to measure area under the concentration-time curve at steady state as the primary endpoint.
Phase 1 design is appropriate for PK comparison but does not evaluate clinical efficacy or safety outcomes.
The source did not state who this applies to in practice.
Phase 1 bioavailability study with no results yet posted; designed to establish pharmacokinetic equivalence between formulations in a planned 120-participant cohort.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07401381). This is a study registration, not published results. Lead sponsor: Rovi Pharmaceuticals Laboratories. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Hormone Receptor Positive Early Breast Cancer. Interventions: DRUG: US-sourced oral Femara® + Letrozole SIE; DRUG: EU sourced oral Femara® + Letrozole SIE. Primary outcome measures: Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau) , After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® on Day 14 TP1. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.