This is a randomized, controlled, open, phase III trial of adjuvant intensive therapy for early breast cancer with HR+/ HER2-SNF4 based on SNF molecular typing. A randomized, controlled, open Phase III study to explore the efficacy and safety of Apatinib combined with standard endocrine therapy in adjuvant intensive therapy for HR+/ HER2-SNF4 type early high-risk breast cancer.
584 patients with lumofacial breast cancer (ER and PR positive, HER2 negative) who received surgery in the Breast Surgery Department of the Affiliated Cancer Hospital of Fudan University were previously collected. The main work was genome sequencing (514 cases of whole exon sequencing, 527 cases of OncoScan microarray), 573 cases of transcriptome sequencing, 228 cases of proteomics (TMT mass spectrometry), 384 cases of metabolomics (liquid chromatography), 439 cases of digital pathology, and partial paired single cell transcriptome sequencing. This group ranks as the largest Asian coelfacial breast cancer multiomics cohort to date. All patients could be divided into four categories by SNF algorithm fusion clustering, namely SNF1 (classical coelateral type), SNF2 (immune-mediated type), SNF3 (proliferative type) and SNF4 (receptor tyrosine kinase-driven type). Different types had unique multiomics and clinicopathological characteristics, which fully analyzed the molecular heterogeneity of coelateral type breast cancer. This is a randomized, controlled, open, phase III trial of adjuvant intensive therapy for early breast cancer with HR+/ HER2-SNF4 based on SNF molecular typing. A randomized, controlled, open Phase III study to explore the efficacy and safety of Apatinib combined with standard endocrine therapy in adjuvant intensive therapy for HR+/ HER2-SNF4 type early high-risk breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
916
Standard endocrine therapy plus Apatinib
3-year survival without invasive disease (iDFS)
3-year survival without invasive disease (iDFS)
Time frame: 3 years
3-year distant disease free survival (DDFS)
3-year distant disease free survival (DDFS)
Time frame: 3 years
5-year overall survival (OS)
5-year overall survival (OS)
Time frame: 5 years
security
Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0
Time frame: through study completion, an average of 1 year
PRO (patient reported outcome)
Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.
Time frame: 5 years
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