advanced breast cancer
Conditions
Interventions
Case series:apatinib or apatinib plus capecitabine
Sponsors
Sui'ning Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18-70 female patients; 2. ECOG PS 0-2 ; 3. Pathologically diagnosed patients with advanced breast cancer; Patients with hormone receptor positive need to undergo standard endocrine therapy failure; HER2 positive patients may receive anti-HER2 treatment during the trial; patients with bone metastases may receive bisphosphonates; Patients with advanced breast cancer who have previously received no more than three chemotherapy regimens (anthracyclines and taxanes must be included) and who have failed treatment with the last chemotherapy regimen; Note: The definition of treatment failure includes (1) disease progression within or within 6 months of neoadjuvant / adjuvant therapy, (2) progress of rescue therapy within 3 months; 4. According to RECIST1.1 standard, there is a measurable lesion [spiral CT scan = 10 mm (CT scan layer thickness is not greater than 5mm)] measurable lesions can be treated with radiotherapy or other topical treatment, but after the completion of treatment; 5. the main organ function is good, patients must meet the following requirements with 14 days before using Apatinib: (1) blood routine examination: hemoglobin> 90 g / L (14 days without blood transfusion); neutrophil count> 1.5 x 109/L; platelet count> 100×10^9/L; (2) biochemical examination: total bilirubin = 1.5 × ULN (normal upper limit); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2 × ULN; Endogenous creatinine clearance = 60 ml / min (Cockcroft-Gault formula); 6. Patients voluntarily joined the study and signed an informed consent (ICF)
Exclusion criteria
Exclusion criteria: 1. Previous capecitabine treatment failed patients; 1. chest wall invasion or large area of ??chest wall ulceration patients; 2. Patients with hypertension who are not well controlled by antihypertensive medications (systolic> 140 mmHg, diastolic> 90 mmHg), previous severe cardiovascular disease: myocardial ischemia or myocardial infarction of grade II or higher, Poorly controlled arrhythmias (including female QTc interval =470 ms); NYHA criteria, grade III-IV cardiac insufficiency, or cardiac ultrasonography revealed left ventricular ejection fraction (LVEF) <50%; 3. Have a variety of factors that affect the oral and absorption of drugs (such as can not swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 4. Past history of bleeding, bleeding symptoms of clinical significance, a clear bleeding tendency in patients. Such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, vasculitis; 5. within 4 weeks had major surgery or severe traumatic injury, fracture, or poor healing wounds; 6. People who have proven to be allergic to apatinib mesylate and / or its accessories; 7. Patients with active brain metastases; 8. Known to be pregnant or plan to become pregnant; 9. Other patients considered by the physician are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR;Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS;QoL; | — |
Countries
China
Contacts
Public ContactHongwei Yang
Sui'ning Central Hospital
Outcome results
None listed