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

Recruiting

• Conditions: ESR1 Gene Mutation; Advanced Breast Cancer; Safety
• Interventions: Drug: ELacestrant

• Registration Number: NCT06544577
• Lead Sponsor: SciClone Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-13
• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ELacestrant	ELacestrant	Subjects in this cohort will receive elacestrant

Primary Outcome Measures

Name	Time	Method
Adverse event rate	6 months	Percentage of occurrences of adverse events

Secondary Outcome Measures

Name	Time	Method
Serious adverse event rate	6 months	Percentage of occurrences of serious adverse events

Trial Locations

Locations (1)

Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan); 🇨🇳 Qionghai, Hainan, China