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

NCT ID: NCT06544577

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-13
• Study Completion Date: 2026-08-01

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.

Conditions

ESR1 Gene Mutation; Advanced Breast Cancer; Safety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ELacestrant

Subjects in this cohort will receive elacestrant

ELacestrant

Intervention Type: DRUG

345 mg/day once daily oral dosing

Interventions

ELacestrant

345 mg/day once daily oral dosing

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SciClone Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Qu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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

Qionghai, Hainan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunyang Li, Doctor

Role: CONTACT

lichunyang@sciclone.com

86-15216717343

Facility Contacts

Chunyang Li, Doctor

Role: primary

lichunyang@sciclone.com

86-15216717343

Other Identifiers

ABC-RWS-01

Identifier Type: -

Identifier Source: org_study_id