Actively Recruiting
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Led by SciClone Pharmaceuticals · Updated on 2024-08-09
350
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have a confirmed diagnosis of breast cancer with locally advanced or metastatic disease unsuitable for surgery or radical radiotherapy
- Female, 18 years of age or older
- Female subjects must be postmenopausal, defined as having undergone oophorectomy, being 60 years or older, being between 40 and 60 years old with at least one year of menopause, or receiving ovarian suppression therapy if under 60 years old
- Confirmed ER-positive, HER2-negative status, and ESR1-mutation positive
- Must have progressed on at least one line of endocrine therapy before enrollment, including monotherapy or combination therapy
- Must have normal organ function as assessed by the investigator
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Known difficulties tolerating oral medications, conditions interfering with oral medication absorption, or allergies to medications and their ingredients
- Other conditions that the investigator considers make study enrollment unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)
Qionghai, Hainan, China
Actively Recruiting
Research Team
C
Chunyang Li, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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