The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Changes in traditional chemotherapy regimens for breast cancer (ie, the addition of carboplatin) are potential ways to improve patient outcomes. Although anthracyclines and cyclophosphamide play a very positive role in the treatment of breast cancer, there are also small and serious long-term risks. Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. Considering of current status of anti-angiogenic drugs in the field of breast cancer, results of apatinib in advanced breast cancer, and current unmet clinical needs, the investigator conducted this study to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
apatinib 250mg,qd,d1-14,14day/cycle
paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle
carboplatin AUC=4,d1,14day/cycle;
Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, China
RECRUITINGpCR rate
pCR defined as no invasive and non-invasive (DCIS) residuals in breast and armpit lymph nodes
Time frame: 3 months
safety of treatment: Incidence of adverse events
Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010)
Time frame: every 2 weeks
rate of breast-pCR
breast-pCR defined as no invasive and non-invasive (DCIS) residuals in breast
Time frame: 3 months
DFS
DFS defined as the time from drug onset until recurrence or death for various reasons.
Time frame: up to 2 years
Rate of breast conserving surgery
Rate of patients with breast conserving surgery
Time frame: 3 months
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