ER-positive postmenopausal metastatic/inoperable breast cancer
Conditions
Interventions
None listed
Sponsors
JA Aichi Konan Kosei Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients who were histologically or cytologically diagnosed as inoperable/metastatic breast cancer. 2. ER-positibe in primary or metastatic lesions. 3.Patient of either of 1 for which endocrinotherapy is needed due to progress relapse breast cancer as follows) -4). 1)Patient who relapsed within 12 months in supplementary treatment period of after the operation by endocrinotherapy or after supplementary treatment ends after the operation. 2)Patient where it relapses after 12 months or more have passed since supplementary treatment ended by endocrinotherapy after the operation, and progress was admitted for endocrinotherapy period afterwards. 3)Patient where progress was admitted for endocrinotherapy period as the first treatment to progress breast cancer patient. 4)Patient from whom progress was admitted in the 2nd or the third endocrinotherapy to progress/recurrence breast cancer 4. The 17th edition (June, 2012)/of the breast cancer handling rule Target (It is possible to measure it) change to a morbid state by the RECIST standard (the 1.1th edition) is possessed. 5.Age 45-year-old or more postmenopausal women. 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Life threatening including 2.Inflammatory breast cancer 3. Allergy to fulvestrant. 4. Previous therapy by fulvestrant 5. Patients considered ineligible by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate(CBR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate(ORR) Progression Free Survival (PFS) Safety | — |
Countries
Japan
Contacts
Public ContactJunichi Tobinaga
JA Aichi Konan Kosei Hospital Breast surgery
Outcome results
None listed