Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Hormone receptor positive,HER2 negative participants will receive letrozole as neoadjuvant endocrine therapy,if don't work, CDK4/6 Inhibitor was added.
Breast Cancer Center, Shandong Cancer Hospital and Institute
Jinan, Shandong, China
RECRUITINGki67 index
Independent review committee (IRC) evaluates the Ki67 index after treatment. Ki67 index using the definition of HE stained breast cancer samples after neoadjuvant therapy and surgery. (Defined by the American Joint Committee onCancer, AJCC).
Time frame: Up to approximately 2 weeks
Objective Overall Response Rate
Defined as the proportion of subjects who achieved CR or PR as optimal tumor response during neoadjuvant therapy. Objective response rates will be assessed according to the RECIST v1.1 for the evaluation of efficacy in solid tumors.
Time frame: Up to approximately 7 weeks
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