NCT04198727

Study of the Impact of DPD Activity on the Efficacy of Capecitabine

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Neoplasm Malignant Female

Interventions

Type	Name	Description
OTHER	DPD activity assessment	Phenotyping DPD with enzyme activity measure and uracil dosage
DRUG	Capecitabine	Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of

Timeline

• Start date: 2020-07-20
• Primary completion: 2026-01-01
• Completion: 2030-07-01
• First posted: 2019-12-13
• Last updated: 2025-05-23

Locations

5 sites across 2 countries: France, Monaco