Breast cancer
Conditions
Interventions
Trial group:Apatinib in combination with Vinorelbine
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced or metastatic triple negative breast cancer confirmed by histopathology (lack of expression of human epidermal growth factor 2 (HER2), estrogen receptor (ER) and progesterone receptor (PR) determined by central laboratory examination) and not suitable for surgical treatment; 2. Patients who have previously received first-line or above systematic treatment, and whose disease has progressed after the last treatment, and who have used anthracyclines and / or taxanes, and there is no standard treatment scheme at present; 3. There must be at least one patient with evaluable lesions judged according to rrecist version 1.1 (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on common CT is at least 20 mm); 4. Female, aged >= 18 years old and =1.5 * 109 / L, platelet count >= 80 * 10^9 / L and hemoglobin >= 8 g / dl; 8. Sufficient liver function: total bilirubin = 50ml / min; 10. Subjects with normal ECG; 11. Women with intact uterus must have a negative pregnancy test result within 28 days before entering the study (unless they have been amenorrhea for 24 months). If the pregnancy test is more than 7 days from the first administration, urine pregnancy test is required for verification (within 7 days before the first administration); 12. Those who did not receive radiotherapy, chemotherapy and targeted therapy within 4 weeks before enrollment; 13. Who signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women, or fertile women without contraceptive measures; 2. Patients with severe acute infection and uncontrolled infection; or patients with purulent and chronic infection and delayed wound healing; 3. Patients with previous severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and intractable hypertension; 4. Patients with bleeding tendency; 5. Mental disorders / patients without informed consent; 6. Patients with drug abuse and long-term alcohol abuse that affect the evaluation of test results; 7. Other situations in which the researcher considered that the patients should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactPeng Peijian
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed