Breast Cancer Clinical Trial
Official title:
Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused
by capecitabine may help doctors plan better treatment.
PURPOSE: This clinical trial is studying blood samples in predicting response to
capecitabine in women with metastatic breast cancer.
OBJECTIVES:
Primary
- To determine the sensitivity, specificity, and positive and negative predictive values
of dihydrouracil/uracil (UH_2/U) ratio measured before starting treatment on grade 3-4
capecitabine-related toxicity in women with metastatic breast cancer.
Secondary
- To prospectively test the value of the germinal genotype of thymidylate synthase (TS)
and methylenetetrahydrofolate reductase (MTHFR) as predictors of resistance to
capecitabine.
- To evaluate the practical feasibility of such pre-therapeutic screening.
- To determine the sensitivity, specificity, and positive and negative predictive values
of dihydropyrimidine dehydrogenase genotyping on grade 3-4 capecitabine-related
toxicity in the first and second courses.
- To evaluate the predictive gain provided by genotyping relative to phenotyping alone.
- To evaluate the influence of TS and MTHFR gene polymorphisms on clinical response and
duration of response.
- To evaluate the pharmacokinetics of capecitabine and its metabolites and their
relationship with UH_2/U and genotype.
- To evaluate the total cost of pre-therapeutic phenotyping alone and the combination of
phenotyping and genotyping.
- To exhaustively analyze the 23 exons of the dihydropyrimidine dehydrogenase (DPYD) gene
in patients who developed toxicity.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.
Blood samples are collected 8-15 days before the start of treatment and periodically on the
first day of treatment for dihydropyrimidine dehydrogenase phenotyping (dihydrouracil/uracil
ratio and high performance liquid chromatography analysis), genotyping (4 most relevant
single nucleotide polymorphisms), and pharmacokinetic analysis.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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