Actively Recruiting
Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk HR+/HER2+ Early Breast Cancer Patients After Anti-HER2 Therapy
Led by Fudan University · Updated on 2026-01-21
1903
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of CDK4/6 inhibitors combined with standard adjuvant endocrine therapy in women with high-risk hormone receptor-positive (HR+) and HER2-positive early breast cancer who have completed anti-HER2 targeted therapy. This Phase III randomized controlled trial aims to assess the effectiveness and safety of this combination treatment compared to endocrine therapy alone. Participants in this study will be randomly assigned to one of two groups: one receiving standard endocrine therapy alone (such as Tamoxifen, Anastrozol, Letrozole, or Exemestane), and the other receiving the same endocrine therapy combined with a CDK4/6 inhibitor for 2 years. The study focuses on patients who have finished adjuvant anti-HER2 therapy within the past year. The trial is open-label, meaning both researchers and participants know which treatment is given. Throughout the 5-year study period, participants will be monitored for invasive disease-free survival as the primary outcome. Secondary outcomes include distant recurrence-free survival, overall survival, safety assessments including adverse events, and patient-reported outcomes over approximately 3 years. Participants will undergo regular follow-up visits and evaluations to assess treatment effects, safety, and quality of life as part of this study sponsored by Fudan University.
CONDITIONS
Brief 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 grade 0 to 1
- Histologically confirmed invasive hormone receptor-positive and HER2-positive breast cancer
- Early-stage breast cancer after radical mastectomy with specific pathological criteria or after neoadjuvant therapy with defined staging
- Completed adjuvant anti-HER2 targeted therapy (such as trastuzumab, T-DM1, or TKI therapy) within 1 year
- Normal major organ function based on blood and biochemical tests
- Female subjects of childbearing potential must use approved contraception during treatment and for 3 months after last dose
- Voluntary participation with signed informed consent and ability to comply with follow-up visits
You will not qualify if you...
- Bilateral breast cancer
- Metastasis to any site
- Use of strong inhibitors or inducers of CYP3/4 enzymes, including specific listed medications and grapefruit products
- History of significant or uncontrolled cardiac disease including recent heart attack or heart failure
- Other malignancies within the previous 5 years except certain cured skin or cervical cancers
- Pregnant or lactating women or those unable to use effective contraception
- Concurrent enrollment in other clinical trials
- Severe or uncontrolled infections
- Active hepatitis B or C infection or abnormal liver function
- History of substance abuse or psychiatric disorders impacting study participation
- Any condition judged by the investigator as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants receive either standard endocrine therapy or standard endocrine therapy combined with CDK4/6 inhibitor therapy for 2 years.
Regular visits during treatment as per protocol
Duration - Up to approximately 3 years
Participants are monitored for safety, adverse events, and survival outcomes after treatment completion.
Visits approximately every few months for safety and patient-reported outcomes
Trial Site Locations
Total: 1 location
1
Fudan cancer center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
M
min he
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here