A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Stage 1 1. ORR
研究概览
简要总结
Stage 1 •To evaluate the efficacy of treatment combinations during Stage 1 based on objective response rate (ORR) •To evaluate the safety of treatment combinations during Stage 1 based on incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v4.0, changes from baseline in vital signs and ECG parameters and change from baseline in targeted clinical laboratory test results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- A Phase Ib/ii, Study Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age >/= 18 years at the time of signing Informed Consent Form
- •ECOG Performance Status of 0 or 1
- •Metastatic or inoperable locally advanced breast cancer
- •Measurable disease (at least one target lesion) according to RECIST v1.1
- •Life expectancy >/= 3 months, as determined by the investigator
- •Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
排除标准
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 or better with the exception of alopecia of any grade and Grade </= 2 peripheral neuropathy
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •Significant cardiovascular disease
- •History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
结局指标
主要结局
Stage 1 1. ORR
Stage 1 1. ORR
Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results
Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results
Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
Stage 1 and 2 2. Change from baseline in vital signs and electrocardiogram parameters
Stage 1 and 2 2. Change from baseline in vital signs and electrocardiogram parameters
次要结局
- Stage 1 2. DCR
- Stage 1 3. OS
- Stage 1 4. DOR
- Stage 1 5. OS at specific timepoints
- Stage 1 1. PFS
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG