Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple negative breast cancer Read More

Inclusion Criteria:

1. patients between18 and 75 Years old;
2. patients with locally advanced breast cancer (TNM periodization:T is equal to or greater than 2,N is equal to 1,M is equal to 0)
3. clear for immunohistochemical is that: estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), the human epidermal growth factor receptor 2 is Negative ( IHC Her-2 0/+ , If ER- 、 PR- But Her-2 ++ , You need to do FISH/CISH Testing confirmed that Her-2 Amplification is negative);
4. The ECOG score is between 0 to 2 points;
5. The expected lifetime is ≥3 months;

6. Major organ function is normal, that meet the following criteria:

   1. Blood test standards subject to:

      HB≥90 g/L ;

      ANC≥1.5×109 /L ;

      PLT≥100×109 /L ;

   2. Biochemical examination must meet the following criteria:

   TBIL≤1.5xULN ( upper limit of normal value ) ;

   ALT AST≤2.5×ULN ;

   Serum Cr≤1.5×ULN And endogenous creatinine clearance rate ≥50 mL/min (Cockcroft-Gault formula ) ;

7. the women of childbearing age must do the pregnancy test ( serum or urine ) within 7 days when they are included in the trial, And the result was negative, and during the trial and at the time of giving experimental drugs after 8 weeks using the appropriate methods of contraception;
8. no difficulty in swallowing, swallowing oral medications;
9. the participants volunteered to join this study should sign the informed consent forms, have better compliance, work in with the follow-up

Exclusion Criteria:

1. patients with pregnancy or lactation;
2. inflammatory breast cancer patients;
3. patients with several factors affecting medication (for example, inability to swallow, such as nausea, vomiting, chronic diarrhea, and bowel obstruction);
4. injury or pathologic fracture;
5. people with high blood pressure and antihypertensive drug treatment could not be reduced to within the normal range (systolic >140 mmHg, diastolic pressure >90 mmHg) ;
6. with ⅱ grade myocardial ischemia, poor control of arrhythmias or myocardial infarction (including QTc interval men ≥450 Ms, female ≥470 Ms);
7. according to NYHA standard ⅲ~ⅳ -class heart insufficiency or heart ultrasound: LVEF(left ventricular ejection fraction) <50%;
8. the past 6 months have gastrointestinal bleeding within history or definite gastrointestinal bleeding, such as: risk of bleeding oesophageal varicose ulcer lesions, fecal occult blood, local activities ≥ (++) Into groups; such as the fecal occult blood (+), requires endoscopy;
9. prior to participating in the study of 28 days abdominal fistula, perforation of the gastrointestinal tract and abdominal abscesses;
10. positive patients of urinary protein (urine protein 2+ or above, or 24 -hour urine protein > 1.0g);
11. distant metastasis of patients with symptoms or are not controlled;
12. expected lifetime < 3 months;
13. into the group before 28 days to accept other anticancer treatment;
14. other information: dysfunction of blood coagulation (INR>1.5 or prothrombin time ( PT )> ULN+4 Seconds); Anticoagulant therapy are receiving antithrombotic or infection who needed intravenous antibiotics; previously receiving bevacizumab treatment or other anti- VEGF TKI Drug treatment, with a second tumor (except basal cell carcinoma and cervical carcinoma in situ);
15. a history of immunodeficiency, including HIV testing positive, or suffer from other acquired, congenital immune deficiency disease or have a history of organ transplantation;