Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSciClone Pharmaceuticals
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ELacestrant
Treatment groups
350 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov