ER-positive postmenopausal metastatic/inoperable breast cancer
Conditions
Interventions
None listed
Sponsors
PerSeUS:Perpetual Study estimated -by United Sections in Gifu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Patients who were histologically or cytologically diagnosed as inoperable/metastatic breast cancer. 3.Postmenopausal (no limit of age). In case of postchemothrapy, amenorrhea during >1 year. In patients who underwent LH-RH ag, the level of FSH and E2 were in level of postmenopausal condition. 4. ER-positibe in primary or metastatic lesions. 5.Patients whose prognosis would be anticipated More than 6 months. 6.PS 0/1 (2 with bone metastasis) 7.Sufficient major organ functions. 8. Patients with (1)measurable regions by RECIST. (2)Bone metastasis detected by CT, MRI, Bone scinti, or PET. 9. Either zoledronic acid, denosumab, RT for local therapy are acceptable. * Re-biopsy will be preferable. ER, Ki67 should be estimated under each institutional criteria such as Allred, J-score.
Exclusion criteria
Exclusion criteria: 1.Life threatening including large liver metastasis, larege brain metastasis, systematic inflammatory lymphangitis in lung. 2.Inflammatory breast cancer 3.Previous therapy by Fluvestrant. 4.Patients who accetted >4th ET. 5. Allergy to Fluvestrant. 6.Patients considered ineligible by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinicalbenefitrate Overallresponse rate Safety | — |
Countries
Japan
Contacts
Public ContactManabu Futamura
Gifu University Departmentofbreast and molecular oncology
Outcome results
None listed