metastatic or locally advanced triple-negative breast cancer
Conditions
Interventions
Group A:Gemcitabine plus capecitabine
Group B:cisplatin plus capecitabine?
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects were willing to join in this study, sign the informed consent, good adherence, and cooperate with the follow-up; 2. Aged 18 to 75 years, females; 3. Histological diagnosed metastatic or locally advanced breast cancer; 4. Histological diagnosed breast cancer and IHC assay shows ER (-), PR (-), HER -2 (-/+); HER-2 (+ +), if need FISH/CISH confirmed that HER-2 amplification was negative; 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 6. ECOG score=2; 7. Expected life time for at least 3 months; 8. the patients without severe heart,lung,liver, kidney system diseases; 9. The main organ function is normal, that is, meet the following standards: (1) Hematologic studies satisfy the following requirements before treatment(no transfusion and hematopoietic growth factor injection within 14 days before randomization): WBC=3.5×10^9/L; ANC=1.5×10^9/L; PLT=100×10^9/L; Hb=90g/L; (2) Adequate renal functio:Serum Cr=1.5×ULN (upper limit of normal); the endogenous creatinine clearance>50 ml/min (Cockcroft-Gault formula); (3) Adequate hepatic function: TBIL=1.5×ULN if has liver metastasis TBIL=1.25×ULN; ALT and AST=2.5×ULN if has liver metastasis ALT and AST=5×ULN; (4) Nomal coagulate functions:International Normalized Ratio (INR) or Prothrombin Time (PT) less than or equal to 1.5 X ULN unless subject is receiving anticoagulant therapy.Activated Partial Thromboplastin Time (aPTT) less than or equal to 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; 10. Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy,who must have a negative urine or blood pregnancy test within 7 days prior to first treatment administration.
Exclusion criteria
Exclusion criteria: 1. Patients who have any concurrent cerebrovascular disease, renal failure, unstable diabetes mellitus,uncontrolled hypertension and pulmonary disease, serious infections, active peptic ulcer, and other complications that may interfere with drug therapy; 2. Who suffered from serious cardiovascular disease: the grade of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 MS); according to the standard of NYHA, III ~ IV heart function is not complete, or echocardiography showed that left ventricular ejection fraction (LVEF) 50%; Urine protein positive patients (urine protein detection of 2+ or more, or 24 hours urine protein quantitative >1.0g) 3. Pregnant or lactation women; 4. Within 4 weeks before randomisation involved in other drug clinical trial, radiotherapy and chemotherapy; allow received radiotherapy for relief of metastatic bone pain before randomisation, but the irradiation of the medullary bone cannot exceed 30% of the total; 5. combination with other anti-cancer drugs; 6. Patients with pre-existing peripheral neuropathy of NCI CTCAE version grade >1; 7. History of severe hypersensitivity to any drug in this trail; 8. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization; 9. Other severe acute or chronic medical or psychiatric condition (including recent or active suicidal ideation or behavior) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) ;Overall Survival (OS) ; | — |
Countries
China
Contacts
Public ContactYueyin Pan
Anhui Provincial Hospital
Outcome results
None listed