The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer
Phase 2
- Conditions
- ER positive postmenopausal advanced breast cancer
- Registration Number
- JPRN-UMIN000012225
- Lead Sponsor
- Gunma university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 57
Inclusion Criteria
Not provided
Exclusion Criteria
1)Active double cancer 2)Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer 3)noninfiltrating cancer 4)Inflammatory breast cancer 5)Serious complication 6)Heart disease that requires treatment, such as ischemic heart disease and abnormal cardiac rhythm (Left ventricular hypertrophy due to hypertension, non-severe left ventricle overload, or non-severe right bundle branch block can be included) 7)Brain metastasis 8)Medication of investigational new drug for diseases other than breast cancer or disorder Taking hormone replacement therapy or selective estrogen receptor 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+LongSD(NC>=24week)
- Secondary Outcome Measures
Name Time Method Changes in QOL Chenges in BMD chenges in fat metabolism