Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer
- Conditions
- ER positive postmenopausal advanced breast cancer
- Registration Number
- JPRN-UMIN000012067
- Lead Sponsor
- Tohoku university school of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Not provided
1) Prior chemotherapy(2 regimen or more) or endocrine therapy 2) Taking radiation therapy for target lesion 3) Taking hormone replacement therapy or selective estrogen receptor 4) History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease) 5) Active double cancer 6) Inflammatory breast cancer 7) Bilateral breast cancer 8) History of allergic reactions for drugs and contract medium to be used in this study 9) Medication of investigational new drug for diseases other than breast cancer 10) Patients who are impossible to be enrolled due to psychological diseases or disorder 11) The case judged inappropriate by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To clarify biological factors and clinical pathological factors as CBR predictive factor of Fulvestrant
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate of Fulvestrant CBR = Response Rate + Long SD Time To Progression Adverse Event Rate