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

Phase 1

• Conditions: Metastatic HER2-negative breast cancer; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002037-31-FR
• Lead Sponsor: Centre Antoine-LACASSAGNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 155

Inclusion Criteria

Age over 18,
PS 0 to 2,
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

Exclusion Criteria

PS> 2,
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified