To hear about similar clinical trials, please enter your email below
Trial Title:
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
NCT ID:
NCT06548919
Condition:
ESR1 Gene Mutation
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Prednisone
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Endocrine therapy
Description:
All endocrine treatment regimens approved for advanced breast cancer, including
tamoxifen, aromatase inhibitors, fulvestrant, etc.
Arm group label:
Chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy Prednisone
Description:
All chemotherapy treatment regimens approved for advanced breast cancer
Arm group label:
Endocrine therapy
Summary:
This is a prospective, non-interventional real-world study to observe the efficacy and
safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced
breast cancer after failure of endocrine therapy.
Epidemiological data, efficacy and safety measures will be collected for each subject.
Data on efficacy and safety assessment indicators will be collected every 2-3 months
until disease progression, receipt of a new anti-tumour treatment modality, death, loss
to follow-up, and arrival at the data collection cut-off date. The cut-off date for data
collection is defined as 8 weeks after completion of 6 visits for each subject, or 4
weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects
receiving a different treatment regimen remained subject to assessment of safety
indicators 4 weeks after discontinuation of the original treatment regimen.
Criteria for eligibility:
Study pop:
Patients with HR+/HER2-advanced breast cancer with ESR1 mutation after failure of
endocrine therapy
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
Locations:
Facility:
Name:
Tianjin Haidafu Internet Hospital
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunyang Li, Doctor
Phone:
86-15216717343
Email:
lichunyang@sciclone.com
Start date:
August 8, 2024
Completion date:
December 31, 2027
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/NCT06548919
