Our study is aimed to explore a prospective observational clinical study on the efficacy prediction and survival prediction of HR + / HER2 - biomarkers detection in patients with advanced breast cancer. This study is a prospective, observational clinical study. We analyzed the incidence of biomarker mutations in HR + / HER2 - advanced breast cancer (stage IV), and the correlation between biomarkers and therapeutic efficacy, survival, and prognosis.
Study Type
OBSERVATIONAL
Enrollment
200
Sun Yat Sen Memorial Hospital,Sun Yat sen University
Guangzhou, Guangdong, China
RECRUITINGCorrelation between biomarkers and efficacy of tumor therapy
explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on.
Time frame: 1 year
overall survival,OS
The time from the beginning of treatment to the death of the patient
Time frame: 2 year
Complete remission, CR
all target lesions disappeared, no new lesions appeared, and tumor markers were normal, which lasted for at least 4 weeks
Time frame: 1 year
Partial remission, PR
the diameter of target lesions diminished more than 30% and lasted for 4 weeks
Time frame: 1 year
Disease stable, SD
the sum of the maximum diameter of the target lesion is smaller than PR, or the increase is not up to PD
Time frame: 1 year
Disease progression, PD
the sum of the maximum diameter of the target lesion increased by at least 20%, and its absolute value increased by at least 5 mm, New lesions are also considered as PD
Time frame: 1 year
Objective response rate , ORR
according to recist1.1 criteria, the proportion of patients whose best remission is CR or PR in the total number of evaluable patients
Time frame: 1 year
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Clinical benefit rate, CBR
according to recist1.1 criteria, the proportion of patients with Cr or PR or SD ≥ 24 weeks in the total number of evaluable patients.
Time frame: 1 year
Quality of life scale score,QoL
The quality of life score of patients during treatment was analyzed(FACT-B). Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale)
Time frame: 1 year