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

NCT04198727 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2017/15
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• 6 months objective response rate

  The primary endpoint will be the 6-month objective response to treatment measured using the RECIST 1.1 scale, or PERCIST 1.0. The objective response is defined as the aggregation of the complete + partial response against stabilization + progression. The distribution of the objective response rate with respect to the value of individual lymphocyte DPD activity before treatment will be examined. This analysis will consist in comparing the objective response rate between patients with a proficient DPD phenotype, measured by lymphocyte DPD activity (\> at the 3rd quartile, ie 25% of the initial population) and non-deficient patients with DPD (including phenotype). between the 13th and 75th percentiles of the initial population).

  6 months

Secondary Outcomes (4)

• 6 months objective response in proficient DPD phenotype

  6 months

• Correlation between the level of lymphocyte DPD activity and uracil dosage

  1 month

• Progression-free survival

  24 months

• Capecitabine Toxicity using CTCAE v 5.0

  24 months

Study Arms (1)

DPD activity

EXPERIMENTAL

Other: DPD activity assessment; Drug: Capecitabine

Interventions

DPD activity assessment OTHER

Phenotyping DPD with enzyme activity measure and uracil dosage

Also known as: Phenotyping

DPD activity

Capecitabine DRUG

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

DPD activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Performance status\> 2,
• Contraindication to capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days,
• 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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead
• Cerbaliance: collaborator

Study Sites (5)

Clinique Saint Jean

Cagnes-sur-Mer, 06800, France

Location

Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

Clinique St Georges

Nice, 06105, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Princesse Grâce

Monaco, 98000, Monaco

Location

MeSH Terms

Interventions

Immunophenotyping; Capecitabine

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: July 20, 2020
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); FR (4)