Status:
UNKNOWN
Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Triple Negative Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC
Detailed Description
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 DC...
Eligibility Criteria
Inclusion
- patients between18 and 75 Years old;
- 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)
- 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);
- The ECOG score is between 0 to 2 points;
- The expected lifetime is ≥3 months;
- Major organ function is normal, that meet the following criteria:
- Blood test standards subject to:
- HB≥90 g/L ;
- ANC≥1.5×109 /L ;
- PLT≥100×109 /L ;
- 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 ) ;
- 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;
- no difficulty in swallowing, swallowing oral medications;
- the participants volunteered to join this study should sign the informed consent forms, have better compliance, work in with the follow-up
Exclusion
- patients with pregnancy or lactation;
- inflammatory breast cancer patients;
- patients with several factors affecting medication (for example, inability to swallow, such as nausea, vomiting, chronic diarrhea, and bowel obstruction);
- injury or pathologic fracture;
- 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) ;
- with ⅱ grade myocardial ischemia, poor control of arrhythmias or myocardial infarction (including QTc interval men ≥450 Ms, female ≥470 Ms);
- according to NYHA standard ⅲ\~ⅳ -class heart insufficiency or heart ultrasound: LVEF(left ventricular ejection fraction) \<50%;
- 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;
- prior to participating in the study of 28 days abdominal fistula, perforation of the gastrointestinal tract and abdominal abscesses;
- positive patients of urinary protein (urine protein 2+ or above, or 24 -hour urine protein \> 1.0g);
- distant metastasis of patients with symptoms or are not controlled;
- expected lifetime \< 3 months;
- into the group before 28 days to accept other anticancer treatment;
- 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);
- a history of immunodeficiency, including HIV testing positive, or suffer from other acquired, congenital immune deficiency disease or have a history of organ transplantation;
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 6 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03348098
Start Date
September 6 2017
End Date
December 6 2018
Last Update
November 28 2017
Active Locations (1)
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1
TianJin Medical University Cancer Institute and Hospital
Tianjin, China, 300060