Overview
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:
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- 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.
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2. female ≥ 18 years of age
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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.
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4. ER-positive and HER2-negative status and ESR1-mutation positive must be
confirmed.
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5. must have progressed on at least one line of endocrine therapy prior to
enrollment, including monotherapy or combination therapy.
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6. have normal organ function (as assessed by the investigator).
Exclusion Criteria:
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- women who are pregnant or breastfeeding
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2. known difficulties in tolerating oral medications, or conditions that interfere
with the absorption of oral medications or allergies to medications and their
excitements
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3. other conditions that make enrollment in the study unsuitable, at the
discretion of the investigator