RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer. PURPOSE: To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Surgery
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Residual cancer burden (RCB 0-I rates）
RCB 0-I rates means RCB 0+I (good response) rates.
Time frame: Time of surgery
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.
Time frame: Time of surgery
pCR in the Breast and Nodes
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.
Time frame: Time of surgery
Near pCR in the Breast
Percentage of patients with the residual breast lump Less than 10%
Time frame: Time of surgery
Clinical and imaging response
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
Time frame: Time of surgery
Number of Participants With Drug Related Treatment Adverse Events
Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.
Time frame: an average of 16 weeks
Neo-bioscore
The Neo-Bioscore staging points were determined for each patient based on information from the medical records according to the previously published work（Mittendorf EA, et al. The Neo-Bioscore Update for Staging Breast Cancer Treated With Neoadjuvant Chemotherapy: Incorporation of Prognostic Biologic Factors Into Staging After Treatment. JAMA Oncol. United States; 2016;2:929-36.）. Neo-Bioscore = Clinical stages score + Pathological stages score + Tumor marker score Clinical stage I =0, Clinical stage IIA =0, Clinical stage IIB =1, Clinical stage IIIA =1, Clinical stage IIIB =2, Clinical stage IIIC =2, Pathological stage 0 =0, Pathological stage I =0, Pathological stage IIA =1, Pathological stage IIB =1, Pathological l stage IIIA =1, Pathological stage IIIB =1, Pathological stage IIIC =2, Tumor marker ER negative=1 Tumor marker Grade3=1 Tumor marker ERBB2 negative=1
Time frame: Time of surgery
Disease-free Survival (DFS)
DFS is defined as the time period between registration and first event
Time frame: Measured through 5 years after study enrollment
Distant-disease- free survival (DDFS)
DDFS is defined as the time period between registration and first event
Time frame: Measured through 5 years after study enrollment
Overall survival (OS)
OS is defined as the time period between registration and first event
Time frame: Measured through 5 years after study enrollment
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