NCT01410708撤回2 期
A Pre-Surgical Study to Evaluate Molecular Changes That Occur in Human Breast Cancer Tissue After Short Term Exposure to Dasatinib and To Correlate These Alterations With Pharmacokinetics Parameters
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
This study will examine the anti-tumor activity, safety and tolerability of dasatinib in adjuvant breast cancer patients in a pre-surgical setting.
详细描述
Primary Objective: To evaluate the molecular changes which occur in human breast cancer tissue after short-term exposure to dasatinib.
Secondary Objectives:
" To evaluate the molecular effects of short term dasatinib exposure in peripheral blood and on SRC (an oncogene) and EPHA2 signaling pathways in non-tumor cells (peripheral blood).
" To correlate the pharmacokinetic parameters with molecular changes detected in breast cancer tissues and peripheral blood " To evaluate the tolerability and safety of short-term exposure to daily dose of 100 mg twice daily of dasatinib administration
Study Design:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed signed consent, female, over 18 years of age nad Karnofsky performance status index greater than 80%.
- •Histologically proven invasive breast cancer through either core needle biopsy or an incisional biopsy. Excisional biopsy not allowed.
- •Tumor must be confined to either the breast or to the breast and ipsilateral axilla. Tumor size of greater than 2cm (T1 with T=2m, T2-T
- •Patient can have clinically positive (N1) or clinically negative)
- •Neutrophils greater than 1.5 x 109/L, Platelets greater tahn 100 x 109/L, Hemoglobin greater than 10g/dL.
- •Total bilirubin less than 1 UNL, AST and ALT less than 2.5 UNL, Alk phos less than 5 UNL, creatinine less than 175umol/L (2mg/dL)
- •not more than 28 days from the time of the initial diagnosis and 8 days from registration to the first dose of dasatinib shall elapse.
- •Patients must be accessible for treatment and the 30-day follow-up and compliant with study procedures.
- •Negative pregnancy test within 7 days prior to registration for women of childbearing potential.
排除标准
- •Prior or concurrent systemic anticancer therapy
- •Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive breast cancer.
- •Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
- •Any T1 (with exception of T1 with T=2cm) or T4 or N2 or known N3 or M1 breast cancer.
- •Concurrent or congestive heart failure, unstable angina pectoris or MI in past 6 months; uncontrolled hypertension or high risk uncontrolled arrhythmias; any history of significant ventricular arrhythmia.
- •History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding of informed consent; active uncontrolled infection.
- •Past or prior history of neoplasm other than breast carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated.
- •Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 2 weeks prior to registration.
- •Concurrent treatment with other experimental drugs or treatment wih investigational drugs with 30 days of registration.
- •Prior hormonal therapy with any hormonal agents such as ralozifene, Tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention.
研究者
研究点 (1)
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