NCT03613181尚未招募3 期
A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Overall survival
研究概览
简要总结
This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •HER2-negative breast cancer
- •At least 2 months of expected survival
- •Newly diagnosed leptomeningeal carcinomatosis
- •Documented history of brain metastasis that has been previously treated with radiation therapy
- •Neurologically stable
- •Eastern Cooperative Oncology Group performance status grade ≤2
- •Adequate laboratory test results prior to first dose
- •Patients who are fertile must agree to remain abstinent or use reliable method of birth control
排除标准
- •Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
- •Prior treatment with ANG1005
- •Patients who have not had radiotherapy for their brain metastases
- •Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
- •Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease
- •Pregnancy or lactation and patients planning to be pregnant during the study
- •Peripheral neuropathy > Grade 2
- •Evidence of severe or uncontrolled diseases
- •Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
- •History of interstitial lung disease
- •Severe conduction disturbance
- •Central nervous system disease requiring immediate neurosurgical intervention
- •Known allergy to paclitaxel or any of its components
- •Contra-indication for contrast-enhanced MRI
研究组 & 干预措施
ANG1005
Experimental
ANG1005 Investigational Drug
干预措施: ANG1005 (Drug)
Physician's Best Choice
Active Comparator
One of the protocol specified Physician's Best Choice therapies, assigned by the Investigator prior to randomization: capecitabine or eribulin or high-dose intravenous (IV) methotrexate.
干预措施: Physician's Best Choice (Drug)
结局指标
主要结局
Overall survival
时间窗: From the date of randomization until death due to any cause, assessed for up to 2 years.
次要结局
- 6-month and 12-month overall survival rates(At 6 and 12 months.)
- Overall survival in triple negative breast cancer patients(From the date of randomization until death due to any cause, assessed for up to 2 years.)
- Leptomeningeal carcinomatosis response rate(Assessed for up to 2 years from first patient randomised.)
- Duration of leptomeningeal carcinomatosis response(Assessed for up to 2 years from first patient randomised.)
- Central nervous system clinical benefit rate at 3, 6 and 12 months(At 3, 6 and 12 months.)
- Central nervous system progression-free survival(From the date of randomization until central nervous system progression, assessed for up to 2 years.)
研究者
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