RecruitingNCT06544577

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

Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+/HER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study


Sponsor

SciClone Pharmaceuticals

Enrollment

350 participants

Start Date

Jul 13, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called elacestrant — a pill-form hormone therapy — for women with advanced or metastatic breast cancer that is estrogen receptor-positive (ER+), HER2-negative, and has a specific ESR1 gene mutation, which often develops after standard hormone treatments stop working. **You may be eligible if...** - You are a woman aged 18 or older with ER+/HER2- breast cancer that has spread locally or to distant sites - Your tumor has tested positive for an ESR1 mutation - Your cancer has progressed on at least one prior hormone therapy - You are postmenopausal or on ovarian suppression therapy **You may NOT be eligible if...** - Your tumor is HER2-positive or estrogen receptor-negative - You have not had prior endocrine (hormone) therapy - You have active or uncontrolled serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGELacestrant

345 mg/day once daily oral dosing


Locations(1)

Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)

Qionghai, Hainan, China

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NCT06544577


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