NCT06544577RecruitingNot Applicable
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 Pharmaceuticals1 site in 1 country350 target enrollmentStarted: July 13, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Adverse event rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
ELacestrant
Subjects in this cohort will receive elacestrant
Intervention: ELacestrant (Drug)
Outcomes
Primary Outcomes
Adverse event rate
Time Frame: 6 months
Percentage of occurrences of adverse events
Secondary Outcomes
- Serious adverse event rate(6 months)
Investigators
Study Sites (1)
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