A Prospective, Open-Label, Single-Arm Phase II Clinical Trial to Explore Chemotherapy Exemption in Elderly Women Aged 65 Years or Older With Lymph Node-Positive ER+/HER2- Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 494
- 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, single-arm Phase II clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged >65 years) with lymph node-positive, HR+/HER2- breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: Female patients aged ≥65 years.
- •Disease Status: Histologically confirmed early-stage breast cancer after surgery with ER expression ≥50% AND one of the following:
- •≥4 positive lymph nodes
- •1-3 positive lymph nodes plus at least one of the following high-risk features: i. High-risk multigene assay result ii. Primary tumor size >2 cm iii. Histologic grade 3 iv. Lymphovascular invasion (LVI) positive v. Ki-67 >20%
- •Treatment Acceptance: Willing to receive adjuvant CDK4/6 inhibitor therapy.
- •Performance Status: ECOG score 0-
- •Adequate Organ Function:
- •a) Hematology (within 14 days, no transfusion): i. Hemoglobin (Hb) ≥90 g/L ii. Absolute neutrophil count (ANC) ≥1.5×10⁹/L iii. Platelets (PLT) ≥100×10⁹/L b) Biochemistry: i. Total bilirubin (TBIL) ≤1.5×ULN ii. ALT/AST ≤3×ULN iii. Serum creatinine (Cr) ≤1×ULN iv. Estimated creatinine clearance (CrCl) >50 mL/min (Cockcroft-Gault formula)
- •Consent & Compliance: Willing to participate, sign informed consent, and comply with follow-up.
排除标准
- •Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).
- •2. Bilateral breast cancer.
- •History of other malignancies, except: Cured basal cell carcinoma of the skin； Carcinoma in situ of the cervix
- •Distant metastasis (any site).
- •Any T4 lesion (UICC 1987 TNM staging), including: Skin invasion; Fixed mass adherence; Inflammatory breast cancer
- •Concurrent participation in other clinical trials.
- •Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including:
- •a) LVEF <50% (by echocardiography) b) Major cardiovascular/cerebrovascular events within 6 months before randomization: i. Unstable angina ii. Chronic heart failure iii. Uncontrolled hypertension (>150/90 mmHg) iv. Myocardial infarction or stroke c) Poorly controlled diabetes mellitus d) Severe hypertension
- •Known allergy to taxane-based drugs or their excipients.
- •Severe or uncontrolled infections.
- •History of psychoactive drug abuse (unable to abstain) or psychiatric disorders.
- •11. Patients deemed ineligible by investigator assessment.
- •Refusal to receive adjuvant CDK4/6 inhibitor therapy.
研究组 & 干预措施
Chemo-free
A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).
干预措施: CDK4/6 inhibitor (Drug)
Chemo-free
A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).
干预措施: Endocrine Therapy (Optional) (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
- Clinical Frailty Scale(Up to approximately 3 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)
- Geriatric assessment (G-8)(Up to approximately 3 years)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University