NCT07130643进行中（未招募）2 期
Single-arm Exploratory Study of Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
Xinhong Wu, PhD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月20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
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •Premenopausal and postmenopausal women or men with stage II-III disease (multifocal and/or multifocal early invasive breast cancer) if all tumors on histopathological examination meet the pathological criteria for ER and/or PR > 10% and HER2- (HER2 expression of 0 or 1+ or 2+ and negative FISH test).
- •3.Patients had to have histologically confirmed ER and (or PR>10%, HER2 -, early-stage invasive disease.
- •4.Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, PD/SD according to tumor evaluation, old age, and basic diseases can not tolerate chemotherapy.
- •ECOG PS score 0-
- •Patients must be able and willing to swallow and retain oral medications.
- •In premenopausal women, a serum or urine pregnancy test had to be negative within 14 days of enrollment or in women who had been amenorrhea for less than 12 months at enrollment.
- •8.Patients who had received neoadjuvant endocrine therapy were eligible if they were enrolled within 6 months of the initial histologic diagnosis and had completed no more than 2 months of neoadjuvant endocrine therapy.
- •Absolute neutrophil count ≥1500/µL, platelet ≥100000/mm3, hemoglobin ≥10g/dL
排除标准
- •Prior treatment with any CDK4/6 inhibitor.
- •Inflammatory or stage IV or bilateral breast cancer.
- •History of allergic reactions caused by chemical or biological components similar to CDK4/6 inhibitors.
- •Patients who received any drugs or substances that were effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
- •Uncontrolled coexisting medical conditions may limit adherence to study requirements.
- •Pregnant women with a negative pregnancy test within 14 days before admission or women of childbearing potential.
- •Patients with a history of any malignancy were not eligible.
- •Patients receiving endocrine therapy within 5 years before diagnosis of current malignancy.
研究组 & 干预措施
treatment
Experimental
CDK4/6 inhibitors+Endocrine Therapy every 28 days for 6 cycles
干预措施: CDK4/6 inhibitors+Endocrine Therapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 24 weeks
ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
次要结局
- change in Ki67(up to 24 weeks)
- complete cell cycle arrest(up to 4 weeks)
- Invasive disease free survival（iDFS）(up to 3 years)
研究者
Xinhong Wu, PhD
PhD
Hubei Cancer Hospital
研究点 (1)
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