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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2030-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasm Malignant Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open-label multi-center prospective cohort study to compare the response of patients with high phenotype to patients with normal phenotype. The analyzes performed will focus on clinical and biological criteria.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DPD activity

Group Type EXPERIMENTAL

DPD activity assessment

Intervention Type OTHER

Phenotyping DPD with enzyme activity measure and uracil dosage

Capecitabine

Intervention Type DRUG

Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of

Interventions

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DPD activity assessment

Phenotyping DPD with enzyme activity measure and uracil dosage

Intervention Type OTHER

Capecitabine

Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of

Intervention Type DRUG

Other Intervention Names

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Phenotyping

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No