Study of the Impact of DPD Activity on the Efficacy of Capecitabine
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 155
- 试验地点
- 10
- 主要终点
- 6 months objective response rate
研究概览
简要总结
This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer. The DPD phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with Capecitabine up to 24 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age over 18,
- •Performance status 0 to 2,
- •Patients with metastatic HER2 negative breast cancer,
- •Patients eligible for capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days,
- •Determination of Uracil level performed according to national recommendations,
- •Patients with at least one lesion evaluable according to the RECIST criteria 1.1, or presenting at least 1 hypermetabolic lesion on PET-TDM according to PERCIST 1.0 criteria. In the case of single cutaneous metastasis (s), it is required to make photographs of lesions with a measure of the lesions using a ruler,
- •Patients receiving social coverage.
排除标准
- •Performance status> 2,
- •Contraindication to capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days,
- •Presence of untreated or uncontrolled symptomatic cerebral or leptomeningeal metastases (unstable corticosteroid requirements) and / or non-clinically stable in the 3 months prior to inclusion,
- •History of cancer, with the exception of cancers in complete remission for more than 5 years, totally resected cutaneous basal cell carcinoma, in situ carcinoma or in situ cervical epithelioma treated,
- •Vulnerable people
研究组 & 干预措施
DPD activity
干预措施: DPD activity assessment (Other)
DPD activity
干预措施: Capecitabine (Drug)
结局指标
主要结局
6 months objective response rate
时间窗: 6 months
The primary endpoint will be the 6-month objective response to treatment measured using the RECIST 1.1 scale, or PERCIST 1.0. The objective response is defined as the aggregation of the complete + partial response against stabilization + progression. The distribution of the objective response rate with respect to the value of individual lymphocyte DPD activity before treatment will be examined. This analysis will consist in comparing the objective response rate between patients with a proficient DPD phenotype, measured by lymphocyte DPD activity (\> at the 3rd quartile, ie 25% of the initial population) and non-deficient patients with DPD (including phenotype). between the 13th and 75th percentiles of the initial population).
次要结局
- Correlation between the level of lymphocyte DPD activity and uracil dosage(1 month)
- 6 months objective response in proficient DPD phenotype(6 months)
- Capecitabine Toxicity using CTCAE v 5.0(24 months)
- Progression-free survival(24 months)