Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Volume Changes as Measured by Perometry
研究概览
简要总结
The purpose of this study is to assess the efficacy of QBX258, a compound developed by Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with stage I-II breast cancer related lymphedema.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-70 with unilateral stage I or II BCRL
- •Volume difference of at least 300 mL between the normal and lymphedematous limb based on perometry evaluation
- •BMI of 18-30
- •No current evidence of breast cancer
- •At least 6 months postop from axillary lymph node dissection
排除标准
- •Bilateral lymphedema or history of bilateral axillary lymph node dissection
- •Recent history of cellulitis in the affected extremity (within last 3 months)
- •Recurrent breast cancer or other malignancy
- •Current (within last month) use of chemotherapy for breast or other malignancy
- •Current (within last 3 months) use of radiation for breast or other malignancy
- •Recent (within last month) or current intensive MLD and/or short stretch bandage use
- •Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
- •Pregnant or nursing (lactating) women
- •Stage III lymphedema
- •Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
研究组 & 干预措施
QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)
This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL).
干预措施: QBX258 (Drug)
结局指标
主要结局
Volume Changes as Measured by Perometry
时间窗: 1 year
Therapeutic volume changes in the arm will be calculated using the methods published by Anderson et al (2000).65 Briefly, the difference in volume measurements between the normal and lymphedematous arms at baseline (i.e volume excess) will be compared to the volume differential after drug treatment and following the washout period using the following formula: (VL-VN) B - (VL-VN) F
次要结局
未报告次要终点