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

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.

Eligibility

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

Conditions5

Browse More Trials