Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889871
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-05-23
Brief Title:
A Randomized Controlled Open-label Clinical Trial of Adjuvant Intensive Therapy for HR HER2-SNF4 Early Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Randomized Controlled Open-label Phase III Clinical Trial of Adjuvant Intensive Therapy for HR HER2-SNF4 Early Breast Cancer Based on SNF Molecular Classification
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None