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Active, Not Recruiting

NCT Number: NCT04198727

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Neoplasm Malignant Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinique Saint Jean, Cagnes-sur-Mer, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPD activity assessment

Other

Phenotyping DPD with enzyme activity measure and uracil dosage

Other names: Phenotyping

Capecitabine

Drug

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

Primary outcomes

  1. 6 months objective response rate

    Time frame: 6 months

    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).

Secondary outcomes

  1. 6 months objective response in proficient DPD phenotype

    Time frame: 6 months

    RECIST 1.1 or PERCIST 1.0 criteria

  2. Correlation between the level of lymphocyte DPD activity and uracil dosage

    Time frame: 1 month

  3. Progression-free survival

    Time frame: 24 months

  4. Capecitabine Toxicity using CTCAE v 5.0

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Collaborators

  • Cerbaliance

Registry information

Acronym: DPDMAX

Important dates

Study start
2020
Primary completion
2026
Study completion
2030
First posted
Dec 13, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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