Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC

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).