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

• Status: Unknown status
• Trial end date: 2018-12-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Paclitaxel

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;