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Trial Title:
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
NCT ID:
NCT06544577
Condition:
ESR1 Gene Mutation
Advanced Breast Cancer
Safety
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
ELacestrant
Description:
345 mg/day once daily oral dosing
Arm group label:
ELacestrant
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.
Criteria for eligibility:
Study pop:
Advanced breast cancer with ER+/HER2- and ESR1- gene mutation
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)
Address:
City:
Qionghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunyang Li, Doctor
Phone:
86-15216717343
Email:
lichunyang@sciclone.com
Start date:
July 13, 2024
Completion date:
August 1, 2026
Lead sponsor:
Agency:
SciClone Pharmaceuticals
Agency class:
Industry
Source:
SciClone Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06544577
