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

Sponsor

Centre Antoine Lacassagne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04198727

Collaborator

Cerbaliance (Other)

155

Enrollment

Locations

Arm

56.4

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Malignant Female	Other: DPD activity assessment Drug: Capecitabine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

155 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 20, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

6 months objective response rate [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 Outcome Measures

6 months objective response in proficient DPD phenotype [6 months]
RECIST 1.1 or PERCIST 1.0 criteria
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Saint Jean	Cagnes-sur-Mer	France	06800
2	Centre Azuréen de Cancérologie	Mougins	France	06250
3	Clinique St Georges	Nice	France	06105
4	Centre Antoine Lacassagne	Nice	France	06189
5	Hôpital Princesse Grâce	Monaco	Monaco	98000

Sponsors and Collaborators

Centre Antoine Lacassagne
Cerbaliance

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Antoine Lacassagne

ClinicalTrials.gov Identifier:

NCT04198727

Other Study ID Numbers:

2017/15

First Posted:

Dec 13, 2019

Last Update Posted:

Oct 7, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Breast Neoplasms

Neoplasms

Capecitabine

Study Results

No Results Posted as of Oct 7, 2021