A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival in patients enrolled in the study and in patients treated per protocol
研究概览
简要总结
The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.
详细描述
- To assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with Alpelisib for metastatic breast cancer.
- To assess the feasibility and safety of treatment with pioglitazone in these patients.
- To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.
- To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.
- To assess the median progression free survival of patients treated according to this protocol
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.
- •Ages 18 - 85
- •ECOG performance status 0, 1 or 2
- •Ability to understand and willingness to sign a written informed consent.
排除标准
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib
- •Uncontrolled diabetes mellitus, defined as HbA1c above 8%
- •Diabetes mellitus controlled by insulin
- •Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnancy
- •Known allergy to pioglitazone
研究组 & 干预措施
Treatment arm
treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Progression free survival in patients enrolled in the study and in patients treated per protocol
时间窗: through study completion, an average of 1 year
Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol
时间窗: through study completion, an average of 1 year
Rate of all grade hyperglycemia in patients enrolled in the study and in patients treated per protocol
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
Ayelet Shai MD
Head of breast cancer unit
Rambam Health Care Campus