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

Phase 2

Active, not recruiting

• Conditions: Breast Neoplasm Malignant Female
• Interventions: Other: DPD activity assessment; Drug: Capecitabine

• Registration Number: NCT04198727
• Lead Sponsor: Centre Antoine Lacassagne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-07-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-01
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DPD activity	DPD activity assessment	-
DPD activity	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (5)

Clinique Saint Jean; 🇫🇷 Cagnes-sur-Mer, France

Centre Azuréen de Cancérologie; 🇫🇷 Mougins, France

Clinique St Georges; 🇫🇷 Nice, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hôpital Princesse Grâce; 🇲🇨 Monaco, Monaco