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

Launched by FUDAN UNIVERSITY · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether adding a type of medication called CDK4/6 inhibitors to standard hormone therapy can help women with a specific kind of early breast cancer called HR+/HER2+. The study aims to find out if this combination is effective and safe for patients who are at high risk after surgery. If you are a woman between the ages of 18 and 70, diagnosed with this type of breast cancer and have completed certain treatments, you might be eligible to participate.

Participants in this trial will receive the new treatment along with standard care, and the study will monitor their health to see how well the treatment works. It's important to know that this trial is not yet recruiting participants, meaning it hasn't started enrolling patients yet. If you decide to take part later, you'll need to meet specific health criteria and agree to regular follow-up visits with the research team. This could be an opportunity to contribute to important research while receiving care for your condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females aged ≥18 and ≤70 years.
• • 2. ECOG systemic status grade 0 to 1.
• • 3. 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.
• • 4. Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN2or pN1 with G3 or ≥5cm; 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
• • 5. 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.
• • 6. 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).
• • 7. 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.
• • 8. Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up visits.
• Exclusion Criteria:
• • 1. Bilateral breast cancer;
• • 2. Metastasis to any site;
• • 3. Taking food or medications that are strong inhibitors or inducers of CYP3/4.
• • 1. 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.
• • 2. Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
• • 4. History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
• • 5. 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;
• • 6. Pregnant or lactating women, women of childbearing age who are unable to use effective contraception;
• • 7. Patients who are concurrently enrolled in other clinical trials;
• • 8. severe or uncontrolled infection;
• • 9. Patients with known active HBV or HCV infection or Hepatitis B DNA ≥500, or chronic stage with abnormal liver function;
• • 10. Those with a history of psychotropic substance abuse that cannot be stopped or those with psychiatric disorders;
• • 11. Patients who, in the judgment of the investigator, are not suitable for participation in this study.