Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.
详细描述
This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.
Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of breast cancer
- •Metastatic or incurable
- •Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor
- •Progression while on or within 6 months of stopping the CDK4/6 inhibitor
- •At least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion
- •Age 18 or greater
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine
- •Comorbid disease other than breast cancer with a life expectancy of less than 2 years
- •Cancer other than breast cancer that is expected to need treatment within 2 years
- •Platelets < 100,000/microliter
- •INR > 1.5
研究组 & 干预措施
Personalized Cancer Treatment Based on Biopsy Results
干预措施: Biopsy-Guided Therapy Selection (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Baseline to 36 Months
No data displayed because Outcome Measure has zero total participants analyzed.
次要结局
- Turn Around Time for Systems Biology Analysis(Baseline to 36 Months)
- Response Rate to Systems Biology Guided Therapy(Baseline to 36 Months)
- Progression Free Survival Base on Concordance With Recommended Treatment(Baseline to 36 Months)