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

NCT07019363 | Recruiting Phase 3

• 1 other identifier: SCHBCC-N091
• Study Type: interventional
• Target: 1,903
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• 5-years Invasive disease free survival

  5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.

  5 years

Secondary Outcomes (4)

• Distant Recurrence-Free Survival (DRFS)

  5 years

• Overall Survival (OS)

  Approximately 5 years

• Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).

  Up to approximately 3 years

• Patient-Reported Outcome (PRO)

  Up to approximately 3 years

Study Arms (2)

Control

ACTIVE COMPARATOR

endocrine therapy

Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Experimental

EXPERIMENTAL

Standard endocrine therapy combined with CDK4/6i

Drug: Standard endocrine therapy combined with CDK4/6 Inhibitor

Interventions

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) DRUG

Standard endocrine therapy

Control

Standard endocrine therapy combined with CDK4/6 Inhibitor DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged ≥18 and ≤70 years.
• ECOG systemic status grade 0 to 1.
• Histologically confirmed invasive HR+/HER2+ breast cancer (Specific definition: breast cancer patients whose estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2) are all determined to be positive by pathologic testing. Specifically: ER positive: IHC\>10%, PR positive: IHC\>10%, HER2 positive: IHC+++ or IHC++ but amplified by FISH.
• Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN1 ; or postoperative pathology suggestive of non-pCR after neoadjuvant therapy; or postoperative pathology suggestive of pCR after neoadjuvant therapy but with clinical staging consistent with cT4 or N3 before neoadjuvant therapy
• Within 1 year of completion of adjuvant anti-HER2 targeted therapy: anti-HER2 targeted therapy includes trastuzumab-based therapy, and/or T-DM1 therapy, and/or TKI therapy.
• The function of major organs is basically normal, and the following conditions are met: ① The criteria for routine blood tests need to be met: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L; ② The biochemical tests need to be met as follows: TBIL ≤ 1.5 × ULN (the upper limit of normal value); ALT and AST ≤ 3 × ULN; serum Cr ≤ 1 × ULN, and endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula).
• Female subjects of childbearing potential are required to use a medically approved form of contraception during study treatment, and for at least 3 months after the last dose of study drug.
• Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up visits.

You may not qualify if:

• Bilateral breast cancer;
• Metastasis to any site;
• Taking food or medications that are strong inhibitors or inducers of CYP3/4.
• Strong inhibitors of CYP3/4 include: boceprevir, clarithromycin, konifactam, delavirdine, indinavir, itraconazole, ketoconazole, ritonavir, mibefradil, miconazole, fazodone, nelfinavir, propoxiconazole, ritonavir, saquinavir, naloxone, telaprevir, telithromycin, voriconazole, grapefruit, grapefruit juice, or grapefruit containing foods.
• Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
• History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
• other malignancy within the previous 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
• Pregnant or lactating women, women of childbearing age who are unable to use effective contraception;
• Patients who are concurrently enrolled in other clinical trials;
• severe or uncontrolled infection;
• Patients with known active HBV or HCV infection or Hepatitis B DNA ≥500, or chronic stage with abnormal liver function;
• Those with a history of psychotropic substance abuse that cannot be stopped or those with psychiatric disorders;
• Patients who, in the judgment of the investigator, are not suitable for participation in this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan cancer center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Anastrozole; Letrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• zhimin shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhi_ming_shao@163.com

min he

CONTACT

zhi_ming_shao@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: June 13, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): May 15, 2029
• Study Completion (Estimated): April 15, 2033
• Last Updated: January 21, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)