Triple negativebreast cancer
Conditions
Interventions
Case series:Apatinib combined with oral etoposide
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily entered the study and signed informed consent form (ICF); 2. Failure to first-line chemotherapy regimen; 3. Aged over 18 years old,female; 4. ECOG score 0-1; 5. Pathologically diagnosed patients with advanced breast cancer. Histological diagnosed breast cancer and IHC assay shows ER (-), PR (-),(ICH nuclear staining of both ER and PR is 5mm,and there is no radiation therapy or other local treatment in the target area unless radiotherapy or other local treatment is completed; 7. Estimated survival time=3 mouths; 8. The main organ function is normal, and meet the following standards: (1) The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2) Biochemical tests should meet the following criteria: BIL45ml/min. 9. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib;
Exclusion criteria
Exclusion criteria: 1. pregnant or lactating women; 2. Participated in other cancer drug clinical trials within four weeks before randomization; 3. Chemotherapy (including nitrosourea or mitomycin for 6 weeks), radiotherapy, molecular targeted therapy, and surgery within 4 weeks prior to the start of the study, did not recover from the acute toxicity of previous treatment to =1 Level (refer to NCI-CTCAE 4.03; if surgery, the wound has completely healed); 4. Those with hypertension and who were unable to fall into the normal range after treatment with hypotensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); had severe cardiovascular disease in the past: myocardial ischemia or myocardial infarction over grade II, and poor control. Arrhythmia (including QTc interphase women more than 470 MS); III ~IV level cardiac insufficiency according to NYHA standard, or cardiac color Doppler examination of left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy. Or there are clear gastrointestinal or other organ bleeding concerned (such as: local active ulcer lesions, fecal occult blood positive); 8. Arterial / venous thrombosis occurred within the first 6 months before randomization, such as cerebral vascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism; 9. long nonunion or incomplete healing of the fracture; 10. urine protein positive patients (urine protein test 2+ or above, or 24 hours urine protein quantitative >1.0g); 11. Serious or uncontrolled infection(NCI-CTCAE 4.03>level 2) 12. patients with mental substance abuse history who are unable to quit or have mental disorders; 13. Used anti-angiogenic drugs and etoposide ( bevacizumab can be used) 14. Have a history of other malignant tumors within 5 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| size of the lesions; | — |
Countries
China
Contacts
Public ContactHailing Lu
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed