Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Apatinib
Intervention description: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Intervention MeSH terms: Apatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Apatinib; HER-2 Negative; Chest wall Metastasis; Multicenter Phase II Study; Breast cancer

Summary:

      The treatment of the patients with recurrent and metastatic breast cancer remains a major
      problem. There is still a lack of effective targeted therapy for Her-2 negative breast
      cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast
      cancer, the investigators believe that it is necessary to further explore the efficacy and
      safety of apatinib in advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HER-2 negative advanced breast cancer with chest wall metastasis confirmed by
             histology or cytological examination (patients who have received anthracyclines and/or
             paclitaxel in adjuvant chemotherapy).

          2. Patients with recurrence or metastasis who have received no more than two lines of
             chemotherapy.

          3. If hormone receptor is positive, endocrine therapy must have been performed for the
             patients with recurrence or metastasis, or the recurrence or metastasis occurred in
             less than two years of endocrine therapy.

          4. ≥ 18 years old.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

          6. A life expectancy of more than 3 months.

          7. At least one measurable site of disease confirmed by CT or MRI according to Response
             Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required.

          8. If the target lesions are lymph nodes, the short diameter is required to be less than
             1.5cm and the target lesions are not suitable for surgical treatment; target lesions
             have not been in radiotherapy or recurred in the radiation field.

          9. Baseline blood routine examination in accordance with the following criteria:
             neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L;
             hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain
             the index)

         10. Liver function in accordance with the following criteria: total bilirubin less than
             1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine
             aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than
             5 times the upper limit of normal value in patients with liver metastases.

         11. Renal function in accordance with the following criteria: serum creatinine less than
             1.25 times the upper limit of normal value, or the creatinine clearance rate
             calculated greater than 50 mL/min;

         12. Women with fertility are willing to take contraceptive measures in the trial: when
             seven days before the drug delivery of serum or urine pregnancy test negative.

        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.