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| Name | Class |
|---|---|
| Cerbaliance | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPD activity | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPD activity assessment | Other | Phenotyping DPD with enzyme activity measure and uracil dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6 months objective response in proficient DPD phenotype | RECIST 1.1 or PERCIST 1.0 criteria | 6 months |
| Correlation between the level of lymphocyte DPD activity and uracil dosage | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Jean | Cagnes-sur-Mer | 06800 | France | |||
| Centre Azuréen de Cancérologie |
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| ID | Term |
|---|---|
| D016130 | Immunophenotyping |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| Capecitabine | Drug | Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of |
|
| Progression-free survival | 24 months |
| Capecitabine Toxicity using CTCAE v 5.0 | 24 months |
| Mougins |
| 06250 |
| France |
| Clinique St Georges | Nice | 06105 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hôpital Princesse Grâce | Monaco | 98000 | Monaco |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |