advanced triple-negative breast cancer
Conditions
Interventions
Case series:apatinib combined with capecitabine
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Advanced triple-negative breast cancer diagnosed by histology or cytology of the primary tumor; 2. At least one measurable lesion; 3. Progression of disease after previous treatment with second line or above; no capecitabine has been used in previous treatment; 4. Female aged at least 18 years old; 5. ECOG PS0-2 points 6. The expected lifetime of patients should be equal to or more than 12 weeks; 7. The main viscera function of patients must be normal, and should meet the following requirements: 1) blood routine examination meeting the standards:ANC=1.5×10^9/L; PLT=80×10^9/L; Hb=90g/L(no blood transfusion and blood components support within 14 days, not using G-CSF and other hematopoietic stimulating factor correction); 2) blood biochemical examination meeting the following standards: TBIL<1.5×ULNALTAST<2.5×ULN, hepatic metastasis ALT, AST < 5 x ULNBUN and Cr=1×ULN, endogenous creatinine clearance =50 ml/min (Cockcroft - Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or have performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, during the test and the last 8 weeks after experimental patients must be used appropriate methods of contraception, or surgery sterilization; 9. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastasis, cancerous meningitis (patients with brain metastasis who have completed treatment and stable symptoms 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms ); 2. Uncontrolled hypertension(systolic pressure = 140 mmHg and/or diastolic pressure = 90 mm Hg) even though two or more than two hypotensive agents application; 3. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%; 4. Coagulation disfunction.or Known inherited and acquired hemorrhagic and thromboplastic possibility; 5. Within 4 weeks of major surgery and/or injures, fractures, ulceration; 6. A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, significantly affecting the use and absorption of drugs); 7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess = 6 months; 8. Urine protein=++, or 24h urine protein quantitation=1.0g; 9. History of psychiatric drugs abuse and not be abstinent, or dysphrenia; 10. Pregnant or lactating women; Patients with fertility unwilling or unable to take effective contraceptive measures; 11. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Contacts
Public ContactGan Lu
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed