Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer — BCTOP-L-M01  

Breast Cancer Clinical Trial

Official title: Study of Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- (Open, Randomized, Phase II )

Status Recruiting

Clinical Trial Summary

This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer. The study was used to explore the efficacy of Everolimus in combination with standard endocrine therapy.

Clinical Trial Description

A total of 584 patients with luminal breast cancer who received surgery in the breast surgery Department of the Affiliated Cancer Hospital of Fudan University were collected in the early stage. All patients could be divided into four categories, namely SNF1 (classical luminal type), SNF2 (immune-mediated type), SNF1 (proliferative type), and SNF4 (receptor tyrosine kinase-driven type), through clustering by the SNF algorithm. SNF1 (classical luminal type): The transcriptional component type is dominated by PAM50 LumA, with high PIK3CA mutation and low TP53 mutation. By combining artificial intelligence based on H&E pathological sections with deep learning methodology, molecular typing can be effectively distinguished. Prior to enrollment, the patient's primary lesion or metastasis was classified by molecular classification based on the H&E section combined with digital pathology, and SNF1 was confirmed to be considered for subsequent enrollment.

Receivers will be randomly assigned 1:1 to either Everolimus plus Standard Endocrine therapy (study group) or Standard Endocrine therapy (control group).

Treatment will continue until disease progression, intolerable toxicity, informed withdrawal, or death from any cause. ;

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Cancer
• Breast Neoplasms

• NCT number: NCT05949541
• Study type: Interventional
• Source: Fudan University
• Contact: Zhimin Shao, MD, PhD
• Phone: +86-021-64175590
• Email: zhimingshao@yahoo.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 26, 2023
• Completion date: January 2028