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

Breast Neoplasm Malignant Female Clinical Trial

— DPDMAX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198727
• Other study ID #: 2017/15
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: April 2026

Study information

• Verified date: November 2023
• Source: Centre Antoine Lacassagne
• Contact: Christine LOVERA
• Phone: +33 492031618
• Email: christine.lovera[@]nice.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: April 2026
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Female
• Breast Neoplasms
• Neoplasms

Intervention

Other:
• DPD activity assessment
Phenotyping DPD with enzyme activity measure and uracil dosage

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

Locations

Country	Name	City	State
France	Clinique Saint Jean	Cagnes-sur-Mer
France	Centre Azuréen de Cancérologie	Mougins
France	Centre Antoine Lacassagne	Nice
France	Clinique St Georges	Nice
Monaco	Hôpital Princesse Grâce	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne	Cerbaliance

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

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