RecruitingPhase 3NCT07019363

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)

A Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"


Sponsor

Fudan University

Enrollment

1,903 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding a CDK4/6 inhibitor to standard hormone therapy helps women with high-risk HR-positive, HER2-positive early breast cancer after completing anti-HER2 treatment. **You may be eligible if...** - You are a woman aged 18–70 with HR-positive, HER2-positive invasive breast cancer - You had a mastectomy and have positive lymph nodes or other high-risk features - You completed anti-HER2 therapy (trastuzumab, T-DM1, or TKI) within the past year - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have another active malignancy - You are pregnant or breastfeeding - Your heart, liver, or kidney function does not meet study criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEndocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Standard endocrine therapy

DRUGStandard endocrine therapy combined with CDK4/6 Inhibitor

CDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy


Locations(1)

Fudan cancer center

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07019363


Related Trials