Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine(TX)versus Docetaxel and Capecitabine(TX)as first-line treatment in patients with recurrent/metastatic triple negative breast cancer.
The control group received docetaxel + capecitabine regimen;Experimental group received Nimotuzumab combined docetaxel + capecitabine regimen.The main purpose is to evaluate Nimotuzumab Plus Docetaxel and Capecitabine(TX)as First-Line Treatment in Patients With Recurrent/Metastatic triple negative breast cancer would improve objective response rate (ORR ) comparing with Docetaxel and Capecitabine(TX).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing cancer hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGORR
Evaluation ORR every six weeks,with RECIST 1.1.
Time frame: every six weeks, up to 1 year
PFS
Time frame: every six weeks, up to 1 year
Number and ratio of AEs
Observe and record AEs when AEs occurred
Time frame: up to 1 year
Relationship of tissue/serum EGFR between efficacy and prognosis
every 6 weeks
Time frame: 1 year
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The General Hospital of the People's Liberation Army (PLAGH)
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGLiaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
NOT_YET_RECRUITINGFuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGXijing Hospital
Xi’an, Shanxi, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province)
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITING