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

NCT07019363 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1903

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Standard endocrine therapy

DRUG

Standard endocrine therapy combined with CDK4/6 Inhibitor

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • zhimin shao · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2029-05-15
Completion
2033-04-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07019363 on ClinicalTrials.gov