A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice
A Multicenter, non-interventional, prospective study to collect efficacy and safety data in
Chinese patients who have received Faslodex 250mg treatment under the condition of actual
usage in clinical practice
- Chinese postmenopausal women with estrogen receptor positive, locally advanced or
metastatic breast cancer Failure to previous anti-estrogen therapy, already received
Faslodex 250mg treatment as determined by treating physician.
- The prescription of the Faslodex is clearly separated from the decision to include
the subject in the NIS, and is part of normal medical practice. The recruitment of
the patient to the study should be within 1 month of the first Faslodex injection.
- Provision of subject informed consent.
- If participating in any controlled clinical trial, the subject cannot take part in
- Hypersensitivity to the active substance, or to any of the other excipients.
- Pregnancy and lactation, or severe hepatic impairment.
Type of Study:
Observational Model: Case-Only, Time Perspective: Prospective
Progression Free Survival (PFS) is defined as from the start of the initial Faslodex 250mg therapy to the first recorded occurrence of objective disease progression or death from any cause.
Outcome Time Frame:
Up to 30 months after the first dose of Fulvestrant according to the NISP
Binghe Xu, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Ministry of Health
- Breast Cancer
- Chinese post-menopausal women
- oestrogen receptor-positive locally advanced
- metastatic breast cancer
- fulvestrant 250mg
- failure to adjuvant anti-oestrogen therapy
- Breast Neoplasms