Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
NCT06544577 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350
Last updated 2024-08-09
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
- DRUG
-
ELacestrant
345 mg/day once daily oral dosing
Sponsors & Collaborators
-
SciClone Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Qing Qu, Doctor · Ruijin Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-13
- Primary Completion
- 2025-08-01
- Completion
- 2026-08-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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