Phase II Study to Investigate Concurrent Lapatinib and Radiotherapy in Locally Advanced or Locally Recurrent Breast Cancer and the Impact on Breast Cancer Stem Cells
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Percentage of Patients Achieving Complete Clinical Response
研究概览
简要总结
This phase II trial studies how well lapatinib ditosylate and radiation therapy work in treating patients with locally advanced or locally recurrent breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib ditosylate together with radiation therapy may be an effective treatment for breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess the clinical complete response rate (CR) after concurrent lapatinib (lapatinib ditosylate) and radiotherapy in patients with locally advanced or locally recurrent breast cancer that is refractory to chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the feasibility of assessing breast cancer stem cells (BCSCs) using flow cytometry and single cell gene expression profiling (SCGEP).
II. To determine the change in the proportion of BCSCs after combined modality therapy.
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
- •Patients with histologically or cytologically confirmed locally advanced breast cancer that is refractory to chemotherapy or other therapeutic agents or with a history of breast cancer with new evidence of a local recurrence (defined as a chest wall or breast recurrence and/or nodal recurrence); the diagnosis will be made based on clinical and pathologic features
- •Patients must be >18 years of age.
- •Karnofsky Performance Status (KPS) score > 70
- •Patts must have normal organ function as defined below:
- •total bilirubin < 1.5 x institutional upper limit of normal
- •AST(SGOT)/ALT(SGPT) < 2.5 x institutional upper limit of normal
- •creatinine < 1.5 x institutional upper limit of normal
- •Patients must have left-ventricular ejection fraction > 50% at baseline.
排除标准
- •Patients who have contraindications to radiotherapy, such as scleroderma, dermatomyositis, or severe cutaneous manifestations of systemic lupus erythematosus (SLE)
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
- •Women who are pregnant or lactating, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the duration of the study
研究组 & 干预措施
Lapatinib Plus Radiation Therapy
Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.
干预措施: lapatinib ditosylate (Drug)
Lapatinib Plus Radiation Therapy
Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.
干预措施: radiation therapy (Radiation)
Lapatinib Plus Radiation Therapy
Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Percentage of Patients Achieving Complete Clinical Response
时间窗: Up to 12 weeks
Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).
次要结局
- Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP(12 weeks)
- Change in the Proportion of BCSCs(Baseline to 12 weeks)
- Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Up to 12 weeks)
- Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes(Up to 12 weeks)
研究者
Kathleen Horst
Assistant Professor of Radiation Oncology
Stanford University