Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.

Detailed Description
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Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc. Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.

Official Title
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Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Conditions
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Breast Neoplasm, Drug Therapy, Polymorphism,Single Nucleotide

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic breast cancer Female An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 At least one measurable lesion Normal cardiac, hepatic, renal and bone marrow functions Life expectancy ≥3 months Discontinuity of previous chemotherapy for a minimum of 4 weeks Exclusion Criteria: Central nervous system metastases Serious or uncontrolled concurrent medical illness History of other malignancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to chemotherapy | Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression. | 1 year | 
| Overall survival | Overall survival is measured from the date therapy is initiated to the date of death or final follow-up. | 5 years | 
| Toxicity | Toxicity, as a measure of safety and tolerability, is assessed by the percent of participants with adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC). Possible toxicities include neutropenia, anemia, thrombocytopenia, nausea and vomitting, allergy, and so on. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast neoplasm, drug therapy, polymorphism, gene