NCT07019363招募中3 期
A Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,903
- 主要终点
- 5-years Invasive disease free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥18 and ≤70 years.
- •ECOG systemic status grade 0 to
- •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.
排除标准
- •Bilateral breast cancer;
- •Metastasis to any site;
- •Taking food or medications that are strong inhibitors or inducers of CYP3/
- •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.
研究组 & 干预措施
Control
Active Comparator
endocrine therapy
干预措施: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) (Drug)
Experimental
Experimental
Standard endocrine therapy combined with CDK4/6i
干预措施: Standard endocrine therapy combined with CDK4/6 Inhibitor (Drug)
结局指标
主要结局
5-years Invasive disease free survival
时间窗: 5 years
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.
次要结局
- 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)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University
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