NCT07745257尚未招募2 期
Efficacy and Safety of Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases：a Multicenter, Single-arm, Phase Ⅱ Trial
Sun Yat-sen University9 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年8月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- CNS progression-free survival(CNS-PFS)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years
- •ECOG PS of 0-1
- •Life expectancy of at least 12 weeks
- •histologically or cytologically documented HR+/HER2- breast cancer
- •radiologically confirmed brain parenchymal metastases without the need for immediate local therapy
- •measurable brain metastasis lesion according to RANO-BM criteria
- •Must have active brain metastases, defined as newly diagnosed brain metastases or progressive brain metastases following prior local therapy
- •Prior systemic therapy must meet all the following criteria：
- •No more than 3 lines of prior systemic therapy for advanced disease
- •No more than 1 line of chemotherapy or antibody-drug conjugate (ADC) administered in the advanced setting
- •No prior CDK4/6 inhibitor therapy for advanced disease, or only 1 line of CDK4/6 inhibitor therapy with treatment duration > 6 months
- •Adequate hematological, hepatic and renal function
- •Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 180 days after the last dose of experiment treatment
- •Patients must be able to participate and comply with treatment and follow-up
排除标准
- •Patients with leptomeningeal metastases, brainstem metastases or skull metastases
- •Prior receipt of anti-angiogenic agents or Culmerciclib
- •Unresolved Grade ≥2 toxicities (per CTCAE Version 6.0) attributable to any prior therapy, except alopecia
- •Patients with visceral crisis,defined as severe organ dysfunction assessed by symptoms, signs, laboratory examinations and rapid disease progression
- •Inability to swallow capsules or tablets
- •Any severe and/or uncontrolled medical disease
- •Other malignancies diagnosed within 5 years, excluding cured non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma
- •Radiographic evidence of tumor invasion of major vessels, or high risk of tumor invasion into major vessels resulting in life-threatening hemorrhage as assessed by the investigator
- •Patients with arterial or venous thromboembolic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
- •Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment
- •Any other condition that the investigator considers inappropriate to participate in this trial
结局指标
主要结局
CNS progression-free survival(CNS-PFS)
时间窗: From enrollment to the end of treatment at 8 months
Time from treatment until disease progression or death per RANO-BM criteria
次要结局
- progression-free survival (PFS)(From enrollment to the end of treatment at 8 months)
- objective response rate (ORR)(From enrollment to the end of treatment at 8 months)
- intracranial objective response rate（IC-ORR)(From enrollment to the end of treatment at 8 months)
- Overall Survival (OS)(From enrollment to the end of treatment at 18 months)
- Safety and Adverse Events(From enrollment to the end of treatment at 9 months)
研究者
wang shusen
Chief Physician
Sun Yat-sen University
研究点 (9)
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