Advanced Breast Cancer
Conditions
Interventions
Group 1:Raltitrexed Combined with Vinorelbine
Group 2:Capecitabine Combined with Vinorelbine
Sponsors
The Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years old; 2. Histologically confirmed breast cancer with radiologically proven metastatic breast cancer 3. ECOG performance status of 0 to 2; 4. Expected life time for at least 3 months; 5. Failure to first-line treatment regimen containing anthracycline and / or purple 7. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the target lesion is lymph nodes, the minimum width should be greater than 1.5, and the target lesion is not suitable for surgery; No prior radiation on target lesion or recurrent in radiation field; 8. Adequate haematological function defined by absolute neutrophil count more than at least 1.5*10^9/L, platelet count more than at least 100*10^9/L, and haemoglobin more than at least 9g/dL(allowed to achieve or maintain the index by blood transfusion); 7. Adequate hepatic function defined by total bilirubin less than 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5*ULN (or less than 5*ULN in case of liver metastases); 9. Adequate renal function defined as serum creatinine less than at least 1.25*ULN or calculated creatinine clearance more than at least 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; 12. Sighned informed consent and agree to comply with the requirements of the research program.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Clinical evidence of central nervous system (CNS) metastases; 3. 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; 4. Significant cardiovascular disease in the last 6 months before randomization, including: Clinically symptomatic heart failure; Uncontrolled or Symptomatic angina, arrhythmia, or myocardial infarction; 5. Pregnant or lactating patients with breast cancer; 6. Patients with psychiatric disease or other reasons of not complying with this study protocol; 7. History of severe hypersensitivity to any drug in this trail; 8. Patients having received any other experimental drug or being involved in another clinical study; 9. 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); 10. Other conditions that are regarded for exclusion by the trialists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;CBR;OS;Quality of Lif; | — |
Countries
China
Contacts
Public ContactYongkui Lu
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed