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

Primary Purpose

Breast Neoplasm Malignant Female

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DPD activity assessment
Capecitabine
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Neoplasm Malignant Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Clinique Saint Jean
  • Centre Azuréen de CancérologieRecruiting
  • Clinique St Georges
  • Centre Antoine LacassagneRecruiting
  • Hôpital Princesse Grâce

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DPD activity

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2019
Last Updated
October 18, 2022
Sponsor
Centre Antoine Lacassagne
Collaborators
Cerbaliance
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1. Study Identification

Unique Protocol Identification Number
NCT04198727
Brief Title
Study of the Impact of DPD Activity on the Efficacy of Capecitabine
Acronym
DPDMAX
Official Title
Study of the Impact of DPD Activity on the Efficacy of Capecitabine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
Collaborators
Cerbaliance

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Malignant Female

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPD activity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
DPD activity assessment
Other Intervention Name(s)
Phenotyping
Intervention Description
Phenotyping DPD with enzyme activity measure and uracil dosage
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of
Primary Outcome Measure Information:
Title
6 months objective response rate
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
6 months objective response in proficient DPD phenotype
Description
RECIST 1.1 or PERCIST 1.0 criteria
Time Frame
6 months
Title
Correlation between the level of lymphocyte DPD activity and uracil dosage
Time Frame
1 month
Title
Progression-free survival
Time Frame
24 months
Title
Capecitabine Toxicity using CTCAE v 5.0
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine LOVERA
Phone
+33 492031618
Email
christine.lovera@nice.unicancer.fr
Facility Information:
Facility Name
Clinique Saint Jean
City
Cagnes-sur-Mer
ZIP/Postal Code
06800
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme Barriere
Facility Name
Centre Azuréen de Cancérologie
City
Mougins
ZIP/Postal Code
06250
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remy Largilier
Facility Name
Clinique St Georges
City
Nice
ZIP/Postal Code
06105
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ophélie CASSUTO
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne CREISSON
Facility Name
Hôpital Princesse Grâce
City
Monaco
ZIP/Postal Code
98000
Country
Monaco
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges Garnier

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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