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IEV407 / Letrozole / Advanced HR+/HER2 Breast Cancer · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for IEV407 as a single agent or combined with endocrine therapy in advanced HR+/HER2− breast cancer, currently recruiting. No results are reported in this registry record; the study is designed to characterize safety, tolerability, dose-limiting toxicities, and adverse events over approximately 2 years of follow-up.
Phase 1, Interventional, Randomized, Sequential, Open label, Treatment purpose. Advanced HR+/HER2- Breast Cancer; age from 18 Years. Intervention: Dose escalation: IEV407 single agent; Dose escalation: IEV407 + fulvestrant; Dose escalation: IEV407 + letrozole; Dose expansion, recommended dose (RD)-1: IEV407 + fulvestra…; Dose expansion, RD-2 (optional dose optimization): IEV407 +…. n = 194. 6 sites across 5 countries.
This is a Phase 1 trial registration for IEV407 as a single agent or combined with endocrine therapy in advanced HR+/HER2− breast cancer, currently recruiting. No results are reported in this registry record; the study is designed to characterize safety, tolerability, dose-limiting toxicities, and adverse events over approximately 2 years of follow-up.
Phase 1 design focuses on safety and tolerability; no efficacy data or clinical endpoints are planned as primary outcomes. Study is actively recruiting; no interim or final safety or efficacy analyses are reported.
This trial is in early phases and no efficacy or safety data are yet available. Clinicians should await results before considering IEV407 for clinical use.
This is a Phase 1 safety and tolerability study in early recruitment with no results posted; it is designed to evaluate dose-limiting toxicities and adverse events, not efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in early phases and no efficacy or safety data are yet available. Clinicians should await results before considering IEV407 for clinical use.
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 (NCT07604571). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 194 participants (ESTIMATED). Conditions: Advanced HR+/HER2- Breast Cancer. Interventions: DRUG: IEV407; DRUG: Fulvestrant; DRUG: Letrozole. Primary outcome measures: Incidence and severity of dose-limiting toxicities (DLTs) , 28 days; Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) , Up to approximately 2 years; Frequency of dose interruptions, reductions and discontinuations , Up to approximately 2 years; Dose intensity , Up to approximately 2 years. Brief summary: The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.