NCT06544577 Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
| NCT ID | NCT06544577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SciClone Pharmaceuticals |
| Condition | ESR1 Gene Mutation |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-07-13 |
| Primary Completion | 2025-08-01 |
Trial Parameters
Eligibility Fast-Check
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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' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 1\. women who are pregnant or breastfeeding * 2\. known difficulties in tolerating oral medications, or conditions