Study of Apatinib Combined With CDK46 Inhibitor and Endocrine Therapy as First Treatment for HRHER2- Advanced Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of Apatinib combined with CDK46 inhibitor and endocrine therapy in treating patients with hormone receptor-positive, HER2-negative advanced breast cancer, specifically the SNF4 subtype. This phase II open-label clinical study aims to prepare for future larger randomized phase III trials by assessing treatment outcomes in this specific breast cancer group. Participants are divided into two groups one group receives Dalpiciclib a CDK46 inhibitor combined with Apatinib and endocrine therapy, while the other group receives Dalpiciclib with endocrine therapy only. Treatments are administered as first-line therapy, focusing on patients with locally advanced or metastatic disease that cannot be treated surgically. During the study, participants will be monitored for progression-free survival, overall response rate, clinical benefit rate, and overall survival over approximately five years. Researchers will assess disease progression or death as primary outcomes and follow patients with regular evaluations, including imaging and lab tests. Participants must consent to follow-up and comply with study procedures throughout the trial.

Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer