Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer
Not Applicable
- Conditions
- ER positive postmenopausal advanced / recurrence breast cancer
- Registration Number
- JPRN-UMIN000012153
- Lead Sponsor
- Sapporo-Kotoni Breast Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1)Taking hormone replacement therapy or selective estrogen receptor 2)History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease) 3)Active double cancer 4)Inflammatory breast cancer 5)Bilateral breast cancer 6)History of allergic reactions for drugs and contract medium to be used in this study 7)Medication of investigational new drug for diseases other than breast cancer 8)Patients who are impossible to be enrolled due to psychological diseases or disorder 9)The case judged inappropriate by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Benefit Rate of Fulvestrant CBR = Response Rate + Long SD (SD>=24week)
- Secondary Outcome Measures
Name Time Method Bone Mineral Density(BMD) before/after treatment of Fulvestrant Bone metabolism maker before/after treatment of Fulvestrant Change of QOL before/after treatment of Fulvestrant Adverse Event Rate