Clinical trial NCT03535961 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: apatinib+oral etoposide
SMILES: [H][C@]12COC(=O)[C@]1([H])[C@H](C1=CC(OC)=C(O)C(OC)=C1)C1=CC3=C(OCO3)C=C1[C@H]2O[C@@H]1O[C@]2([H])CO[C@@H](C)O[C@@]2([H])[C@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 75 year-old women; HER2 negative(immunohistochemistry or
             fluorescence in situ hybridization);

          -  ECOG score: 0-1, expected survival time ≥ 3months;

          -  Pathologically or cytologically confirmed breast cancer;

          -  Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who
             have failed from 1-2 standard chemotherapies after recurrence and metastasis;

          -  According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm，other examination
             >2cm);

          -  The patients have enough organ function. The laboratory test indexes must comply with
             the following requirements:

               -  Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L

               -  Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT
                  and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper
                  limit of normal value when liver metastasis

               -  Renal function: serum creatinine ≤ 1.0times the upper limit of normal value,
                  creatinine clearance >50ml/min（Cockcroft-Gault formula)

          -  Women of child-bearing age should be carried out pregnancy test (serum or urine)
             within 7 days before recruit, the results should be negative; and are willing to adopt
             the appropriate methods of contraception during the trial and 8 weeks after last
             administration；

          -  Can swallow oral drugs;

          -  The patients have good compliance to the therapy and follow-up to be scheduled and are
             able to understand the study protocol and sign the Informed Consent Form.

        Exclusion Criteria:

          -  The patients in pregnancy or lactation growth period and did not take effective
             contraception;

          -  The patients who received ≥3 chemotherapies（Do not include endocrine therapy）after
             recurrence and metastasis; involved in other clinical trials four weeks prior to the
             start of the study;

          -  The patients with a variety of factors that affect the oral administration and
             absorption of drugs;

          -  The patients previously received anti-VEFG of anti-VEGFR therapies;

          -  The patients with rapid progression of viscera invasion(liver lesion >1/2 viscera area
             or liver dysfunction);

          -  The patients have uncontrollable mental illness.

          -  The patients who had serious adverse effect to oral etoposide or were allergic to
             etoposide.

          -  The patients who have only bone metastasis without other measurable lesion;

          -  The patients experience severe cardiovascular diseases;

          -  The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.

          -  Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin
             <90g/L);

          -  Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value);

          -  Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);

          -  The patients have uncontrollable brain metastasis;

          -  The patients do have good compliance to the therapy.