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

NCT06544577 | Recruiting FDA Drug

• 1 other identifier: ABC-RWS-01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  Percentage of occurrences of adverse events

  6 months

Secondary Outcomes (1)

• Serious adverse event rate

  6 months

Study Arms (1)

ELacestrant

Subjects in this cohort will receive elacestrant

Drug: ELacestrant

Interventions

ELacestrant DRUG

345 mg/day once daily oral dosing

ELacestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced breast cancer with ER+/HER2- and ESR1- gene mutation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• SciClone Pharmaceuticals: lead

Study Sites (1)

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

Qionghai, Hainan, China

RECRUITING

MeSH Terms

Interventions

elacestrant

Study Officials

• Qing Qu, Doctor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyang Li, Doctor

CONTACT

86-15216717343; lichunyang@sciclone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: July 13, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)