Study of the Impact of DPD Activity on the Efficacy of Capecitabine (DPDMAX)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Malignant Female
• Intervention / Treatment: Other: DPD activity assessment; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine LOVERA; Phone Number: +33 492031618; Email: christine.lovera@nice.unicancer.fr

Study Locations

• France
  • Cagnes-sur-Mer, France, 06800
    • Not yet recruiting
    • Clinique Saint Jean
    • Contact: Jérôme Barriere
  • Mougins, France, 06250
    • Recruiting
    • Centre Azuréen de Cancérologie
    • Contact: Remy Largilier
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Anne CREISSON
  • Nice, France, 06105
    • Not yet recruiting
    • Clinique St Georges
    • Contact: Ophélie CASSUTO
• Monaco
  • Monaco, Monaco, 98000
    • Not yet recruiting
    • Hôpital Princesse Grâce
    • Contact: Georges Garnier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DPD activity	Other: DPD activity assessment; Phenotyping DPD with enzyme activity measure and uracil dosage; Other Names: Phenotyping; Drug: Capecitabine; Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival		24 months
6 months objective response in proficient DPD phenotype	RECIST 1.1 or PERCIST 1.0 criteria	6 months
Correlation between the level of lymphocyte DPD activity and uracil dosage		1 month
Capecitabine Toxicity using CTCAE v 5.0		24 months

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne
• Collaborators: Cerbaliance

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: 2017/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No