Actively Recruiting
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
Led by SciClone Pharmaceuticals · Updated on 2024-08-12
450
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed breast cancer with locally advanced or metastatic disease unsuitable for radical treatment
- Female aged 18 years or older
- Postmenopausal female (by oophorectomy, age 60 or older, or other menopause criteria)
- ER-positive and HER2-negative status with confirmed ESR1 mutation
- Progressed on at least one line of endocrine therapy
- Normal organ function as assessed by the investigator
You will not qualify if you...
- Pregnant or breastfeeding women
- Known intolerance or allergy to oral medications
- Conditions interfering with oral medication absorption
- Other conditions deemed unsuitable for study enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Haidafu Internet Hospital
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
C
Chunyang Li
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here