NCT05889871

A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 916 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HR+/HER2-breast Cancer

Interventions

Type	Name	Description
DRUG	Standard endocrine therapy plus Apatinib	Standard endocrine therapy plus Apatinib

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-06-05
• Last updated: 2023-06-05