| Eligibility |
Inclusion Criteria:
1. Performance Status 0-1
2. Life expectancy longer than 3 months
3. Histological proven unresectable recurrent or advanced breast cancer
4. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human
epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2
negative). A negative Her2 gene amplification should be verified by FISH test for
those patients with Her2 (2+)
5. Patients must have progressed after 1 or 2 prior chemotherapy regimens for metastatic
disease, and consistent with the following treatment failure definition: progress in
the first-line or second-line regimen treatment, or follow-up disease progression less
than 3 months after completion of their last dose
6. At least one extracranial measurable disease according to the response evaluation
criteria in solid tumor (RECIST 1.1)
7. Radiation therapy within 4 weeks prior to enrollment
8. All patients enrolled are required to have adequate hematologic, hepatic, and renal
function
9. Be able to understand the study procedures and sign informed consent
Exclusion Criteria:
1. Patients had prior treatment with vinorelbine
2. Pregnant or lactating women, women of child-bearing potential, unwilling to use
adequate contraceptive protection during the process of the study
3. Patients with symptomatic central nervous system metastases are not permitted, except
for those with stable and asymptomatic brain metastases who have completed cranial
irradiation, and have at least one measurable lesion outside the brain. Radiotherapy
should be completed within 4 weeks prior to the registration
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
6. Uncontrolled serious infection
7. Unhealed wound or bone fracture
8. Patients with hypertension and uncontrolled hypertension with hypotensive drugs
therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
Patients with grade I or above myocardial ischemia or myocardial infarction or
arrhythmia (including QT interval = 440 ms) or cardiac insufficiency
9. Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of
the intestine, various factors which affect drug use and absorption
10. Coagulation disorders (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg < 2g / L) Being treated
with thrombolytic or anticoagulant therapy, with bleeding tendency or definite
gastrointestinal bleeding concerns (eg: local active ulcer lesions, fecal occult blood
+ + or above)
11. Artery or venous thrombosis occurred within 6 months before the study begins, such as
cerebrovascular accident (including transient ischemic attack), deep vein thrombosis,
and pulmonary embolism, etc.
12. Patient who has a history of psychotropic substance abuse and is unable to stop or
have a history of mental disorders
13. Have received prior treatment with a VEGFR TKI (Bevacizumab is permitted)
14. Another malignancy within 5 years, except for cured basal cell carcinoma of the skin
and cervical carcinoma
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