ER positive postmenopausal advanced breast cancer
Conditions
Interventions
Fulvesutrant,Tamoxifen
Sponsors
Gunma university
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Postmenopausal 2)Recurrence/Advance Breast Cancer 3)Histological confirmed invasive breast cancer by biopsy 4)Prior endocrine therapy 5)Measurable lesion 6)Cytological confirmed breast cancer 7)Estrogen receptor(ER) positive by Immunohistochemistry(IHC=>1%) confirmed by biopsy before treatment 8)Principal organs(bone marrow, heart, kidneys, etc.)are functionally preserved 9)ECOG performance status(P.S.)0,1or 2 10)Written informed consent 11)Patients projected to live at least for 3M or longer from the trial start
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate of Fulvestrant CBR=Response Rate+LongSD(NC>=24week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in QOL Chenges in BMD chenges in fat metabolism | — |
Countries
Japan
Contacts
Public ContactToru Higuchi
Gunma university school of medicine Department of thoracic and visceral Organ surgery
Outcome results
None listed