Breast cancer
Conditions
Interventions
chemotherapy capecitabine 1657mg/m2, cyclophosphamide 65mg/m2, q3w, 6cycles
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
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)Required to have received previous systemic chemotherapy containing the anthracycline 4)No previous systemic chemotherapy with taxanes or oral doxifludine/cyclophosphamide combination. Permitted to enter this trial, only if more than one year passed after the completion of preoperative or postoperative settings using these drugs. 5)Performance status of 0, 1, or 2 6)Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function 7)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 survival(PFS), overall survival(OS), adverse event | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Executive Office
Outcome results
None listed