Breast Cancer
Conditions
Interventions
S-1 is administered orally twice daily at a dose of 40-60 mg (80-120 mg/day), depending on the BSA and creatinine-clearance from days 1 to 14, which is followed by 7 days rest. This treatment is repe
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Histologically confermed breast cancer patients of female (2)Metastatic or recurrent breast cancer. 1) Patients with distant metastasis of breast cancer. 2) Refractory or recurrent breast cancer. Local recurrence is excluded. (3) Patients submitted written informed consent to participate in this clinical study. (4)Patients with measurable lesions based on RECIST v.1.1. (5) no prior chemotherapy or 1 to 2 regimens for metastatic or recurrent breast cancer. (6) Eastern Cooperative Oncology Group performance status 0,1 (7) 1)previously treated with no orally-administered fluorinated pyrimidine 2)more than 24weeks interval after adjuvant or neoadjuvant chemotherapy of orally-administered fluorinated pyrimidine (8) The values of laboratory findings within 21 days prior to registration meet all the criteria listed below. 1) neutrophil count: >=1,500/mm3 or leucocytes count: >=3,000/mm3 2)platelet count: >=100,000/mm3 3)total-billirubin:<=2.5 times the upper limit of center standard. 4) AST(GOT)and ALT(GPT): <=2.5 times the upper limit of center standard 5) serum creatinine : within the upper limit of center standard
Exclusion criteria
Exclusion criteria: (1) HER2 positive (IHC:3+ or FISH +) (2) History of non-breast malignancies within the 5 years prior to study entry (3) Symptomatic brain metastasis (4) Diffuse liver meta, or carcinomatous lymphangitis. (5) In addition, the case that a investigator judged to be inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate Progression-free survival Time to failure Adverse events | — |
Countries
Japan
Contacts
Public ContactAkira Hirano
Tokyo Women&#39;s Medical University, Medical Center East Department of Breast Surgery
Outcome results
None listed