Breast Cancer
Conditions
Interventions
Case series:Xeloda
Sponsors
Peking University Cancer Hospital (Beijing Cancer Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients must give written informed consent and agree to comply with the requirements of this study protocol; 2. Women with histologically or cytologically confirmed locally recurrent or matastatic disease of the breast who had no prior chemotherapy for locally recurrent or matastatic disease; 3. No HER2 overexpression or gene amplication, and ER/PR receptor status be recorded; 4. Age =18 years; 5. ECOG Performance Status 0-1; 6. Estimated life expectancy =3 months; 7. Adequate haematological function defined by absolute neutrophil count =1.5 x 10^9/L, platelet count=100 x 10^9/L, and haemoglobin=9g/dL (allowed to achieve or maintain the index by blood transfusion); 8. Adequate hepatic function defined by total bilirubin <1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x ULN (or <5 x ULN in case of liver metastases); 9. Adequate renal function defined as serum creatinine =1.25 x ULN or calculated creatinine clearance=50 mL/min according to Cockroft-Gault formula; 10. Normal coagulate functions; 11. Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to first treatment administration.
Exclusion criteria
Exclusion criteria: 1. Received prior chemotherapy, immunotherapy, biologic therapy or molecular targeted therapy for metastatic disease.(Note: patients may have had hormonal therapy for metastatic disease); 2. Recurrence/metastases happened within 6 months after neoadjuvant/ajuvant chemotherapy finished; 3. Radiotherapy within the 28 days before randomization. Allow received radiotherapy for relief of metastatic bone pain before randomisation, but the irradiation of the medullary bone cannot exceed 30% of the total; 4. Clinical evidence of central nervous system (CNS) metastases; 5. Patients who have any concurrent uncontrolled pulmonary disease, serious infections, active peptic ulcer, unstable diabetes mellitus, connective tissue diseases or bone marrow suppression, and could not tolerate the study drugs; 6. Significant cardiovascular disease in the last 6 months before randomization, including: Clinically symptomatic heart failure; Uncontrolled or Symptomatic angina, arrhythmia, or myocardial infarction; Uncontrolled hypertension (Systolic blood pressure >180mm Hg or diastolic blood pressure >100mmHg); 7. Patients with pre-existing peripheral neuropathy of NCI CTCAE version grade >1; 8. Pregnant or lactating patients with breast cancer; 9. Patients with psychiatric disease or other reasons of not complying with this study protocol; 10. History of severe hypersensitivity to any drug in this trail; 11. Patients having received any other experimental drug or being involved in another clinical study; 12. History of second primary malignancy in the last 5years (except: adequately treated in situ carcinoma of the cervix and squamous cell carcinoma of the skin, or completely controlled basal-cell carcinoma of the skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;safety; | — |
Countries
China
Contacts
Public ContactHuiping Li
Peking University Cancer Hospital (Beijing Cancer Hospital)
Outcome results
None listed