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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Nov 15, 2017

Keywords

ClinConnect Summary

NACT (Neoadjuvant chemotherapy) Increasingly widespread in clinical practice, there is still a substantial proportion of the patients NACT After failing to obtain ORR DCR , NACT Did not receive ORR DCR Patient access ORR DCR Patients have a higher risk of recurrence, and complete NACT The patient, the current standard therapy in the secondary stage of chemotherapy is no longer used, but non-ORR non-DCR After neo-adjuvant chemotherapy in patients with postoperative chemotherapy is worth exploring. Targeted drugs refer to interfere with tumor specific molecular processes and achieve inhibit o...

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Eligibility criteria

• 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;