Unresectable or/and recurrent breast cancer
Conditions
Interventions
Drug: TS-1, Cyclophospamide
TS-1: 80 mg/m2/day po on day 1-14
Cyclophospamide 100 mg/day po on day 15-28
Sponsors
Fujii Takaaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases registered in this study must satisfy all of the following conditions. 1)Have histological confirmation of breast cancer with recurrent and/or metastatic lesion. 2)A phase 1 study:There is no need for measurable lesion. A phase 2 study:Patients who have measurable lesion. 3)Age 20-75 4)The patient must have no carry-over of efficacy from any previous treatment (Surgery: 2 weeks, radiation therapy: 2 weeks, endocrine therapy and trastuzumab: 4 weeks) 5)Performance Status (ECOG Scale) 0-1 6)Patients able to take orally. 7)Body surface area >1.25m2 8)Adequate baseline organ and marrow function as defined below; Leukocytes:>=3,500/mm3 Absolute neutrophil count:>=2,000/mm3 Platelets:>=100,000/mm3 Hemoglobin:>=9.0 g/dl AST(GOT):=60ml/min (Cockcroft-Gault):female Ccr =body weightx(140-age)/(72xcreatine)x0.85 9) Patients should sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with serious complication as followings, (Uncontrolled diabetes mellitus, active infection, severe heart disease (unstable angina, myocardial infarction( within 6 months)), mental disease) 2) Patients with findings of interstitial pneumonia or pulmonary fibrosis by chest X-P. 3) Patients with symptomatic brain metastasis 4) Patients with a history of severe drug hypersensitivity. 5) Active second primary malignancy (except adequately treated carcinoma in situ or malignancy treated more than 5 years ago without recurrence) 6) Women in pregnancy, at risk of pregnancy. 7) During administration of fluoropyrimidines, flucytosine, and pentostatin. 8) Patients who had recurrent disease within one year after administration of fluoropyrimidine or cyclophosphamide based chemotherapy. 9) Patients with previous administration of tegafur / gimeracil/ oteracil. 10) Patients judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression-free survival, safety | — |
Contacts
Public ContactTakaaki Fujii
Gunma University
Outcome results
None listed