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Study of the Impact of DPD Activity on the Efficacy of Capecitabine | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT04198727•Centre Antoine Lacassagne

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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

Locations (5)

Clinique Saint Jean

Cagnes-sur-Mer, France

Centre Azuréen de Cancérologie

Mougins, France

Clinique St Georges

Nice, France

Centre Antoine Lacassagne

Nice, France

Hôpital Princesse Grâce

Monaco, Monaco

Key Dates

Start Date

July 20, 2020

Primary Completion Date

January 1, 2026

Completion Date

July 1, 2030

Last Updated

May 23, 2025

Enrollment

155

ESTIMATED participants

Conditions

Breast Neoplasm Malignant Female

Interventions

DPD activity assessment

OTHER

Capecitabine

DRUG

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

NCT03109080

Breast Neoplasms, Triple-NegativeBreast Neoplasm Malignant Female+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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