NCT07796880招募中2 期
Neoadjuvant Culmerciclib Combined With Endocrine Therapy Versus Endocrine Therapy Alone for Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: a Single-center, Open-label, Randomized-controlled Phase II Clinical Trial
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of participants achieving Residual Cancer Burden (RCB) grade 0 or 1
研究概览
简要总结
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients with Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative early-stage breast cancer.
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
- •Able to understand study procedures, voluntarily participate in the study, and provide written informed consent.
- •Female patients aged ≥18 and ≤70 years with histopathologically confirmed untreated unilateral primary invasive breast cancer.
- •Hormone-receptor positive (estrogen receptor immunohistochemical expression ≥10%), and HER2-negative (IHC 0-1+, or IHC 2+ with negative FISH test).
- •Tumor size >2 cm or positive regional lymph nodes (TNM stage II-IIIA).
- •At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate cardiac function meeting all of the following criteria:
- •i. 12-lead electrocardiogram shows no abnormality or clinically insignificant changes requiring no medical intervention; ii. QTc interval ≤480 ms; iii. No history of torsades de pointes or other symptomatic QTc abnormalities; iv. Left-ventricular ejection fraction (LVEF) ≥50%.
- •Adequate bone-marrow reserve: white blood cell count ≥3.0×10⁹/L; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L.
- •Adequate hepatic and renal function: AST and ALT ≤2.5 × upper limit of normal (ULN); alkaline phosphatase ≤2.5 × ULN; total bilirubin ≤1.5 × ULN; serum creatinine ≤1.5 × ULN.
- •For pre-menopausal females or females without surgical sterilization: agree to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment.
排除标准
- •Occult breast cancer, inflammatory breast cancer, Paget's disease of the breast, stage IV (metastatic) breast cancer, or bilateral breast cancer.
- •Known hypersensitivity to active ingredients or other excipients of study drugs.
- •Requirement for additional anti-tumor therapy (excluding ovarian function suppression) during neoadjuvant treatment, as judged by the investigator.
- •Prior hormone-replacement therapy that has not been discontinued for at least 2 weeks before study treatment initiation.
- •Previous history of anti-tumor chemotherapy, selective estrogen-receptor modulators, or aromatase inhibitor therapy.
- •Severe cardiac diseases or conditions that would preclude tolerability of study treatment, including but not limited to:
- •i. Life-threatening arrhythmias or higher-grade atrioventricular block (Mobitz type II second-degree or third-degree atrioventricular block); ii. Unstable angina pectoris; iii. Clinically significant valvular heart disease; iv. Electrocardiogram evidence of transmural myocardial infarction; v. Poorly controlled hypertension.
- •Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from such surgical procedures.
- •Severe or uncontrolled infections that may interfere with study treatment or outcome assessment, including but not limited to active viral hepatitis, positive human immunodeficiency virus antibody, pulmonary infection.
- •History of other malignancies within the past 5 years (except cured carcinoma in-situ of cervix or basal-cell carcinoma of skin).
- •Underlying gastrointestinal disorders (especially chronic diarrhea or constipation), inability to swallow, intestinal obstruction, or other conditions interfering with drug intake and absorption.
- •Any other condition rendering the patient unsuitable for study participation, in the investigator's opinion
研究组 & 干预措施
Aromatase inhibitor
Active Comparator
干预措施: Aromatase Inhibitor (AI) (Drug)
Culmerciclib combined with aromatase inhibitor
Experimental
干预措施: Culmerciclib (Drug)
Culmerciclib combined with aromatase inhibitor
Experimental
干预措施: Aromatase Inhibitor (AI) (Drug)
结局指标
主要结局
Rate of participants achieving Residual Cancer Burden (RCB) grade 0 or 1
时间窗: Within 4 weeks after surgery
Proportion of subjects achieving RCB-0 or RCB-1 scores for tumor in the breast tumor bed and regional lymph nodes following neoadjuvant therapy, calculated using the online calculator available on the MD Anderson official website, as assessed by pathologists blinded to treatment assignment. Subjects who discontinued study treatment and received other non-protocol-specified neoadjuvant therapy prior to definitive surgery, subjects who did not undergo surgery, and subjects with missing efficacy information will be categorized as not achieving RCB-0/I (non-responders).
次要结局
- Pathological complete response rate(Within 4 weeks after surgery)
- Objective response rate(Within 2 weeks of breast MR examination)
- Endocrine Prognostic Index score 0 rate(Within 4 weeks after surgery)
- Complete Cell Cycle Arrest (CCCA) rate(Within 4 weeks after surgery)
- Breast conservation surgery rate(Within 4 weeks after surgery)
- 5-year event-free survival(During the 5 years after random assignment)
- 5-year overall survival(During the 5 years after random assignment)
- Safety (AEs+SAEs)(from signing the informed consent form until 2 years after completion of neoadjuvant treatment)
- Health-related Quality of Life 1(Within 7 days before the first treatment and the end of each cycle (each cycle is 28 days))
- Health-related Quality of Life 2(Within 7 days before the first treatment and the end of each cycle (each cycle is 28 days))
研究者
Chang Gong
Clinical Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (2)
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