Metastatic/Advanced Breast Cancer
Conditions
Interventions
Dose the TS-1 of 80mg/m2 in alternate-day.
Sponsors
Wakayama Medical University, Department of Thoracic and Cardiovascular Surgery
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed primary breast cancer 2)Satisfies any of the following in a diagnosis of metastatic breast cancer. 1.Inoperable for distant metastasis in an initial diagnosis. 2.The cause that recurred or progressed is distant metastasis. 3)Evaluable lesions are at least one or more. 4)Received no previous chemotherapy, or only two regimen. 5)Age >= 20 years 6)ECOG performance status of 0 or 1 7)Hormonal therapies-resistant and Satisfies any of the following. 1.ER-negative breast cancer 2.Hormonal therapies-resistant in the therapy for metastatic breast cancer. 3.A recurrence during six months after adjuvant hormonal therapies or the surgery. 8)Satisfies all of the following about precedent treatment (including the adjuvant setting). 1.Pass more than 7 days, after the hormonal therapies end. 2.Pass more than 14 days, after the radiotherapy end. 9)Results from a laboratory test meet the following WBC >= 3,500/mm3 Neu >= 2,000/mm3 Hb >= 9.0g/dL Plt >= 100,000/mm3 T-Bil <= 1.5mg/dL AST <= 100 IU/L ALT <= 100 IU/L Cre <= 1.2mg/dL Ccr >= 60mL/min 10)Be able to be administered orally. 11)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Active double cancer. 2)Watery diarrhea. 3)Require administration of flucytosine, phenytoin, and warfarin. 4)The metastases to brain which require measures for the brain hypertension and urgent brain irradiation. 5)Extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea. 6)A lesion targeted for an evaluation is only one, and there is an enforcement history of the radiotherapy to the part. 7)Pleural effusion, ascitic fluid, pericardial effusion to need urgent treatment. 8)Severe infections being suspected. 9)Interstitial pneumonia or pulmonary fibrosis. 10)HBs antigen is positive. 11)The diabetes patients with difficult control or during treatment with insulin. 12)Serious mental disorder. 13)Pregnant woman, a nursing mother or has a hope for the pregnancy. 14)The patients who are inappropriate to the study which judged by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | — |
Countries
Japan
Outcome results
None listed