Metastetic Breast Cancer
Conditions
Interventions
2 group:QOL
Sponsors
Taiwan THL Co.Ltd
Eligibility
Sex/Gender
Male
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subject aged 20 to 80 years old (inclusive); 2. Subject with histologically and/or cytologically confirmed breast cancer with clinical evidence of progressive metastatic disease and with any of the following conditions: a. No satisfactory response after primary or salvage treatment modality (chemotherapy, radiotherapy or surgery); b. No intention to accept further conventional treatment modality; 3. Subject having adequate bone marrow function (absolute neutrophil count >=1000/uL, hemoglobin count >=8g/dL, and platelet count > 75,000/uL) liver and renal function (total serum bilirubin < 3 mg/dL and serum creatinine < 2 mg/dL); 4. Subject with estimated life expectancy of at least 4 weeks; 5. Subject having given written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject having ever received radiotherapy, endocrine therapy or antineoplastic within 2 weeks before study; 2. Subject having ever received hormonal agent as adjuvant treatment or as therapy for metastatic within 2 weeks before study; 3. Subject with any uncontrolled infection; 4. Subject with history of autoimmune disease, such as lupus erythematosus, ankylosing spondylosis, scleroderma or multiple sclerosis; 5. Subject is diagnosed with any other malignant tumor within 3 years prior to the study entry, except skin basal cell carcinoma; 6. Subject's AST, ALT > 5*upper limit of normal values or > 10*upper limit of normal values if liver metastases were present; 7. Subject with any other serious diseases/medical history considered by the investigator not in the condition to enter the trial; 8. Subject being lactating, pregnant or plans to be become pregnant; 9. Subject having participated other investigational study within 4 weeks of entering this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| EORTC QOL; | — |
Countries
China
Contacts
Public ContactWisdom Lin
Outcome results
None listed