Pilot / Phase II Randomised, Double Blind, Placebo Controlled Multicenter Study With Biomarker Evaluation of Neoadjuvant Exemestane in Combination With Sunitinib in Post-menopausal Women With Hormone- Sensitive, Her-2 Negative Primary Breast Cancer.
试验速览
- 阶段
- 1 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Recommended dose of sunitinib malate that can be combined with exemestane
研究概览
简要总结
RATIONALE: Sunitinib malate and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sunitinib malate and exemestane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sunitinib malate to see how well it works when given together with exemestane in treating postmenopausal women with breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safe dose level of sunitinib malate that can be combined with exemestane (pilot phase I).
- Evaluate the clinical response of neoadjuvant therapy comprising exemestane and sunitinib malate in postmenopausal women with hormone receptor-positive and HER-2 negative primary breast cancer (phase II).
Secondary
- Evaluate the safety and feasibility of this regimen in these patients.
- Evaluate the percentage of patients undergoing breast-conserving surgery after completion of study therapy.
- Determine the safety profile of this regimen in these patients.
- Determine the rate of complete pathological response in the breast and axillary lymph nodes at the time of surgery.
- Determine the extent of treatment-related inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases.
- Find a genetic profile, based on the analysis of CYP19A1 polymorphisms, able to predict response to exemestane in neoadjuvant setting.
- Conduct exploratory investigation of biomarkers expression before and during therapy in order to identify molecular characteristics of responding tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Patients receive oral exemestane and oral placebo once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: exemestane (Drug)
Group 1
Patients receive oral exemestane and oral placebo once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
Group 2
Patients receive oral exemestane once daily and oral sunitinib malate once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: exemestane (Drug)
Group 2
Patients receive oral exemestane once daily and oral sunitinib malate once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Recommended dose of sunitinib malate that can be combined with exemestane
Objective clinical response (complete or partial response) according to WHO criteria
次要结局
- Safety and feasibility of the combination of sunitinib malate and exemestane
- Safety profile
- Rate of breast-conserving surgery
- Percentage of pathological complete response in the breast and axillary lymph nodes
- Grade of inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases
- Genetic profile, based on the analysis of CYP19A1 polymorphisms, able to predict response to neoadjuvant exemestane
- Molecular biomarkers predictive of response