Metastatic Triple-Negative Taxane-Resistant Breast Cancer: Investigating the Role of Bexarotene in Inducing Susceptibility to Chemotherapy by Differentiating Cancer Cells From a Mesenchymal-Like to an Epithelial-Like Phenotype
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tumour protein profile by multiplex immunohistochemistry
研究概览
简要总结
Triple-negative breast cancer (TNBC) is biologically aggressive and has limited systemic treatment options, often compounded by treatment resistance.
Cell state transitions, e.g. epithelial-to-mesenchymal transition (EMT) govern cancer cell behaviour.
The investigators hypothesize that by inducing change in cell state change, TNBC cells that have manifested taxane-resistance will be more sensitized to subsequent chemotherapy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically proven metastatic TNBC
- •Patients whose TNBC has progressed after prior taxane therapy in the (neo)adjuvant or metastatic setting, and have not received Capecitabine or 5-fluorouracil
- •Females aged 21 years and older
- •ECOG performance status 0 or 1
- •Life expectancy greater than three months
- •Patients have normal organ and marrow function
- •Site(s) of disease amenable to serial bedside biopsies before, during and after study treatment
排除标准
- •Previous palliative radiotherapy to potentially biopsy-able lesion
- •Active symptomatic central nervous system (CNS) metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation
- •Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures
研究组 & 干预措施
Bexarotene and Capecitabine
干预措施: Bexarotene (Drug)
Bexarotene and Capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Tumour protein profile by multiplex immunohistochemistry
时间窗: From time of first biopsy before the start of study treatment, to disease progression, up to 2 years
To characterize the changes in tumour protein profile upon treatment
Tumour transcriptome by RNA sequencing
时间窗: From time of first biopsy before the start of treatment, to disease progression, up to 2 years
To characterize the changes in tumour transcriptome upon treatment
次要结局
- Incidences of treatment related adverse events(From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years)