NCT02720185终止2 期
Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (nEGFR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Plasma Membrane Epidermal Growth Factor Receptor (EGFR) Expression, Measured by VECTRA Imaging
研究概览
简要总结
Primary Objective:
To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear translocation of the epidermal growth factor receptor (EGFR) in Stage I-III, nuclear EGFR positive, triple negative breast cancers (TNBC).
Secondary Objectives:
- To examine the safety and tolerability of dasatinib in patients with operable TNBC
- To explore potential intracellular mechanisms which impact dasatinib effect on cellular localization of EGFR in operable TNBC.
- To examine the pathologic complete response (pCR) rates to standard neoadjuvant chemotherapy in nEGFR+ TNBC
- To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+ TNBC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who are receiving any other investigational agents
- •Patients not able to swallow oral medications or with gastrointestinal conditions that may impact absorption of dasatinib.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib.
- •Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, medications should be reviewed by the UW Pharmacy Research Center for any contraindicated medications. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
- •H2 antagonists and proton pump inhibitors are not allowed
- •Anticoagulants (ie. Coumadin, heparin, anti-Xa inhibitors) and anti-platelet agents (ie. aspirin) are not allowed. NSAIDS and acetaminophen are allowed on study.
- •Medications known to prolong QTC are not allowed (See Appendix B)
- •No history of prolonged QTC or cardiomyopathy unless normal QTC and ejection fraction confirmed within 1 month prior to study entry.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because dasatinib is a pregnancy category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dasatinib, breastfeeding should be discontinued if the mother is treated with dasatinib and not resumed until at least 2 weeks after the final dose.
- •HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with dasatinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- •Contraindication to repeat breast biopsy (neoadjuvant chemotherapy group)
研究组 & 干预措施
Dasatinib 100mg
Experimental
Dasatinib 100mg for 7-10 days until day prior to surgery
干预措施: Dasatinib (Drug)
Dasatinib 100mg
Experimental
Dasatinib 100mg for 7-10 days until day prior to surgery
干预措施: Conventional Surgery (Procedure)
Dasatinib 100mg
Experimental
Dasatinib 100mg for 7-10 days until day prior to surgery
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Plasma Membrane Epidermal Growth Factor Receptor (EGFR) Expression, Measured by VECTRA Imaging
时间窗: 7-10 days
An increase of at least 25% from baseline to post-dasatinib treatment will be considered significant. VECTRA is an automated pathology imaging system used to detect biomarkers in samples.
次要结局
- Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks(Up to 4 weeks)
- Number of Participants With Pathologic Complete Response (pCR)(Up to 4 weeks)
- Number of Participants With No Evidence of Disease (NED) at Long-term Follow up(up to 24 months)
研究者
研究点 (2)
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