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

SciClone Pharmaceuticals

Status

Enrolling

Conditions

ESR1 Gene Mutation

Safety

Advanced Breast Cancer

Treatments

Drug: ELacestrant

Study type

Observational

Funder types

Industry

Identifiers

NCT06544577

ABC-RWS-01

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
1. female ≥ 18 years of age
1. 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.
1. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
1. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
1. have normal organ function (as assessed by the investigator).

Exclusion criteria

1. women who are pregnant or breastfeeding
1. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
1. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator