NCT06544577

Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC

Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+/HER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: SciClone Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.

Conditions

• ESR1 Gene Mutation
• Advanced Breast Cancer
• Safety

Interventions

Type	Name	Description
DRUG	ELacestrant	345 mg/day once daily oral dosing

Timeline

• Start date: 2024-07-13
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study