Actively Recruiting
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
Led by Fudan University · Updated on 2026-01-21
1903
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 to 70 years
- ECOG performance status 0 or 1
- Histologically confirmed invasive hormone receptor-positive and HER2-positive breast cancer
- Early-stage breast cancer after surgery with specific pathology staging
- Completed adjuvant anti-HER2 targeted therapy within 1 year
- Normal major organ function with specified blood and biochemical test values
- Use of effective contraception during treatment and for 3 months after
- Voluntary enrollment with signed informed consent and compliance with follow-up visits
You will not qualify if you...
- Bilateral breast cancer
- Cancer metastasis to any site
- Use of strong CYP3/4 inhibitors or inducers
- History of significant or uncontrolled cardiac disease
- Other malignancy within the past 5 years except certain skin and cervical cancers
- Pregnant or breastfeeding women or inability to use contraception
- Concurrent enrollment in other clinical trials
- Severe or uncontrolled infection
- Active hepatitis B or C infection or abnormal liver function
- History of psychotropic substance abuse or psychiatric disorders
- Investigator judgment deeming participant unsuitable for study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan cancer center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
CONTACT
M
min he
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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