Breast Cancer
Conditions
Interventions
1:paclitaxel plus gemcitabine
2:paclitaxel sequential gemcitabine
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sighned informed consent and agree to comply with the requirements of the research program; 2. Histological or cytological diagnosed inoperable recurrent or metastatic breast cancer in patients who had not received chemotherapy(Adjuvant chemotherapy in patients receiving taxane drugs, DFS should be more than 1 years); 3. HER-2, ER/PR receptor status be recorded, IHC, FISH/CISH are all available; 4. 18 years old or above; 5. ECOG physical state of 0-1; 6. Expected life time for at least 3 months; 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); 9. 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); 10. 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; 11. Normal coagulate functions; 12. 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 higher than 180mm Hg or diastolic blood pressure higher than 100mmHg); 7. Patients with pre-existing peripheral neuropathy of NCI CTCAE version grade higher than 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;ORR;OS; | — |
Countries
China
Contacts
Public ContactHuiping Li
Outcome results
None listed