Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Recruiting now
Conditions studied: ESR1 Gene Mutation, Advanced Breast Cancer, Safety
In brief
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.
Key facts
- Study ID
- NCT06544577
- Run by
- SciClone Pharmaceuticals
- People needed
- 350
- Starts
- 2024-07-13
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-08-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan) — Qionghai, Hainan, China (enrolling)
Full record on ClinicalTrials.gov
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