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
SciClone Pharmaceuticals
350 participants
Jul 13, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- \. 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.
- \. female ≥ 18 years of age
- \. 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.
- \. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
- \. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
- \. have normal organ function (as assessed by the investigator).
Exclusion Criteria3
- \. women who are pregnant or breastfeeding
- \. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
- \. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Interventions
345 mg/day once daily oral dosing
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06544577