Breast cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Inoperable advanced or recurrent breast cancer 2)Negative HER2 status (0 or 1+ by immunohistochemistry or negative by FISH) 3)Performance status of 0, 1, or 2 4)Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function 5)Written informed consent is required to obtain from each patient at each participating institution
Exclusion criteria
Exclusion criteria: 1)Pregnant or breast feeding 2)Documented history of serious hypersensitivity reaction on the medical drugs 3)Patients who have experienced prior chemotherapy with capecitabine 4)With metastasis to the central nervous system 5)Serious underlying medical illness with heart, gastrointestinal tract, or infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free time, overall survival, adverse event. | — |
Countries
Japan
Contacts
Kyushu Breast Cancer Study Group Office