Advanced Breast Cancer, ESR1 Gene Mutation, Safety
Conditions
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.
Interventions
DRUGELacestrant
345 mg/day once daily oral dosing
Sponsors
SciClone Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 6 months | Percentage of occurrences of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse event rate | 6 months | Percentage of occurrences of serious adverse events |
Countries
China
Contacts
Primary ContactChunyang Li, Doctor
Outcome results
None listed