Study of the impact of DPD activity on the efficacy of capecitabine - DPD MAX

Centre Antoine-LACASSAGNE0 个研究点目标入组 155 人开始时间: 2019年10月11日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Age over 18,
•Patients with metastatic HER2 negative breast cancer,
•Patient eligible to a treatment with capecitabine in monotherapy at 2000 mg/m2/D, 14 days every 21 days,
•Patient with a Uracilemia dosage performed following the French health recommendation
•Patients with at least one assessable lesion according to the RECIST criteria 1.1.
•Patients who have been informed and signed the informed consents (including the specific consent for DPYD genotyping),
•Patients with social coverage.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 95

•Contraindication to Capecitabine treatment in monotherapy at 2000 mg/m2/D, 14 days every 21 days,
•Presence of known symptomatic cerebral or leptomeningeal metastases treated or uncontrolled (unstable corticosteroid requirements) and / or not clinically stable within 3 months before inclusion,
•History of cancer, with the exception of cancers in complete remission for more than 5 years, completely resected cutaneous basal cell carcinomas, in situ carcinomas or In situ cervical epithelioma treated,
•Vulnerable people as defined in Article L1121-5 to -8

发起方