Breast cancer
Conditions
Interventions
Group 1:Capecitabine
Group 2:Vinorelbine
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult females (aged 18-75 years, including 18 and 75 years); 2. The expected survival time is not less than 3 months; 3. Pathology confirmed that hormone receptor (ER and PR) was negative and HER2 was negative in advanced breast cancer; If there are multiple pathological results, triple negative breast cancer is defined as the final subtype according to the pathological molecular subtype of the last biopsy. 4. Metastatic breast cancer confirmed by pathology is not suitable for local surgery; 5. After 4-8 courses of first-line chemotherapy, there was no progress (including Cr / PR / SD)( Negative expression of Er means that the tumor size is less than 1% by immunohistochemistry Cell staining; PR negative: immunohistochemical staining of less than 1% tumor cells; HER2 negative: 0,1 + or fish / CISH (negative); 6. ECoG PS 0-2, no disease deterioration in the past 2 weeks; 7. At random, the previous treatment-related toxicity should be alleviated to NCI CTCAE (version 4.0) = 3.0 x 10 ^ 9 / L, B. neutrophil count (ANC) >= 1.5 x 10 ^ 9 / L, C. platelet count (PLT) >= 75 x 10^9/L; 9. The liver and kidney functions were basically normal within 1 week before admission (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) = 60 ml / min; 10. Sign informed consent.
Exclusion criteria
Exclusion criteria: Any of the following items cannot be grouped: 1. A patient who is pregnant or breast-feeding; 2. Central nervous system metastasis (including brain parenchyma, pia mater and meningeal metastasis); 3. Diagnosis of any other malignant tumor within 3 years prior to randomization, except for adequately treated basal cells or squamous cell skin cancer or cervical cancer in situ; 4. It may interfere with the accompanying disease or condition involved in the study, or any serious medical disorder that may affect the safety of the subject (eg, uncontrollable heart disease, high blood pressure, active or uncontrollable infection, active hepatitis B) Viral infection); 5. In addition to hair loss, did not return to CTCAE grade I or below toxicity, including hand and foot syndrome, severe neurotoxicity; 6. Within 7 days from the last radiotherapy; 7. Failure to follow the protocol or to take oral medication; 8. Research drugs have been used in previous adjuvant therapy; 9. Participating in other clinical trials; 10. It is known to have a history of allergies to research drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Countries
China
Contacts
Public ContactHerui Yao
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed