Status:
RECRUITING
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Lead Sponsor:
SciClone Pharmaceuticals
Conditions:
ESR1 Gene Mutation
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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' comp...
Eligibility Criteria
Inclusion
- 1\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
- 2\. female ≥ 18 years of age
- 3\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy.
- 4\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
- 5\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
- 6\. have normal organ function (as assessed by the investigator).
Exclusion
- 1\. women who are pregnant or breastfeeding
- 2\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
- 3\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Key Trial Info
Start Date :
July 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06544577
Start Date
July 13 2024
End Date
August 1 2026
Last Update
August 9 2024
Active Locations (1)
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1
Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)
Qionghai, Hainan, China