cdk4/6 inhibitors combined with standard adjuvant endocrine therapy in high-risk, hr+/her2+ early breast cancer patients

Conditions: Breast Cancer; Adjuvant Therapy

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.


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.