Clinical trial NCT04198727: Study of the Impact of DPD Activity on the Efficacy of Capecitabine
Official title: Study of the Impact of DPD Activity on the Efficacy of Capecitabine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Neoplasm Malignant Female
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
Collaborators: name: Cerbaliance
First posted: 2019-12-13
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 6 months objective response rate
timeFrame: 6 months
Secondary outcomes:
measure: 6 months objective response in proficient DPD phenotype
timeFrame: 6 months
measure: Correlation between the level of lymphocyte DPD activity and uracil dosage
timeFrame: 1 month
measure: Progression-free survival
timeFrame: 24 months
measure: Capecitabine Toxicity using CTCAE v 5.0
timeFrame: 24 months
Other outcomes:
Locations:
city: Cagnes-sur-Mer
country: France
facility: Clinique Saint Jean
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nice
country: France
facility: Clinique St Georges
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Monaco
country: Monaco
facility: Hôpital Princesse Grâce
Study officials:
References: