Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006)

Exclusion Criteria

• •1. receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment to relieve the metastatic bone pain is allowed, but medullary bone radiated should not exceed 30% of the total amount;
• •2. symptomatic central nervous system metastases;
• •3. current or recent (30 days before enrollment) use of another study drug or being involved in another clinical study;
• •4. Other malignant tumors that have occurred within 5 years (except for the cured or well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin basal cell carcinoma);
• •5. With hypertension and the blood pressure cannot be reduced to the normal range through antihypertensive drug treatment (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).
• •6. With grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval more than or equal to 450 ms for men, more than or equal to 470 ms for female);
• •7. according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography;
• •8. abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds or APTT \>1.5 times the ULN), with bleeding tendency or under thrombolysis or anticoagulation therapy;
• •9. within 3 months before enrollment, clinically significant bleeding symptoms occur, or having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, occult blood + + and above in baseline period, or suffering from vasculitis, et al;
• •10. within 4 months before enrollment receiving major surgery or getting severe traumatic injury, fracture or ulcer;
• •11. having factors that affect the absorption of the oral drugs obviously, such as the inability to swallow, chronic diarrhea and intestinal obstruction, et al;
• •12. urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;
• •13. with symptomatic serous cavity effusion, which needs to be surgically managed (including pleural effusion, ascites, pericardial effusion);
• •14. with other possible conditions that can affect the clinical research or evaluation of the results judged by the researchers.