metastatic postmenopausal breast cancer with refractory to estrogen therapy
Conditions
Interventions
One of the 3rd generation aromatase inhibitors, such as Anastrozole (1mg),Letrozole (2.5mg) or Exemestane (25mg) is orally administered once a day.
Fulvestrant(500mg)is intramuscular injected day1,
Sponsors
Department of Breast and Endocrine Surgery Graduate school of Medical Sciences, Kumamoto University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. The case signed informed consent of the patients for the registration 2. The case confirmed by pathological diagnosis 3. Post menopausal women with breast cancer (not less than 50 yo) 4. The case who had progressive disease during the estrogen (ethinyl-estradiol) treatment 5. The case with measurable metastatic / recurrent site or evaluable bone metastasis 6. The case that survival more than 3 months is anticipated 7. The case with PS 0,1 or 2 8. The case with a satisfactory function of a heart/liver/bone marrow and to satisfy the nest condition Hb; more than 8 g/dL, AST and ALT; Lessthan 2.5 times of the normal value limit of the institution, BUN; not more than 25mg/dL, Crea; not more than 1.5 mg/dL
Exclusion criteria
Exclusion criteria: 1. The case with active other malignancies 2. The case with HER2 positive tumor 3. The case with bilateral breast cancer 4. The case with inflammatory breast cancer 5. The case with past history of drug allergy or hypersensitivity 6. The case with severe progressive situation with non-indication ofr the hormone therapy 7. The case determined in appropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical benefit rate; CBR | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure, Response rate, Time to chemotherapy, Overall survival, Adverse events, Predictive factors | — |
Countries
Japan
Contacts
Public ContactYutaka Yamamoto
Kumamoto University Hospital Department of Breast Cancer Molecular Targeting Therapy
Outcome results
None listed