Associations Between Genetic Polymorphisms of Drug Transporter Genes and Toxicity of Doxorubicin and Cyclophosphamide Chemotherapy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- .1-The frequency of the genetic polymorphisms of ABCB1 in breast cancer patien
研究概览
简要总结
polymorphisms of drug transporter genes may influence of Doxorubicin-Cyclophosphamide toxicity in breast cancer patients.
the investigators want to
evaluate the association between associations between genetic polymorphisms of ABCB1,SLC22A16 Genes and Toxicity of Doxorubicin and Cyclophosphamide Chemotherapy in Breast Cancer Patients treated by Doxorubicin-Cyclophosphamide regimen therapy
详细描述
breast cancer is the most common cancer diagnosed in women .Breast cancer can occur in both men and women, but it's far more common in women.
The etiology of breast cancer possesses a multifactorial origin , showing as risk factors reproductive age, early menarche, late menopause, nulli parity, exogenous hormones ,smoking, obesity, diet, alcohol consumption, physical inactivity, and genetic and environmental factors(1).
Chemotherapy combination usually used in treat breast cancer specially cyclophosphamide which is alkylating agent and doxorubicin which is cytotoxic drug.
Doxorubicin entry to the cell is facilitated by the solute importer SLC22A16,the efflux of AC drugs uses several ATP-binding cassette transporters (ABC),( ABCB1, ABCC1, ABCC2, ABCG2)(2),(7).
Most chemotherapeutic agents are not specific against neoplastic cells , also affecting normal cells. Which result in a wide range of adverse reactions in virtually all tissue of body. Unfortunately, chemotherapy-induced toxicities are commonly affecting cancer patients with various intensity, and could be the reason for treatment delays and significantly lowered quality of life. Hematological and gastrointestinal toxicities are common in patients treated with cyclophosphamide and doxorubicin(3).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who has confirmed diagnosis of breast cancer.
- •patient who will be treated with cyclophosphamide and doxorubicin(AC) regimen only .
- •patient take drug regimen for first time.
排除标准
- •Patients with metastatic disease and with other previous tumors were excluded from this study
- •Pregnant or nursing female.
- •The patients who were diagnosed with cardiovascular disease or with low left ventricular ejection fraction.
- •4 .patients who had benign breast cancers, or had no clinical pathological information
结局指标
主要结局
.1-The frequency of the genetic polymorphisms of ABCB1 in breast cancer patien
时间窗: up to 24 week
the blood samples will be DNA extracted using DNA extraction kit then single nucleotide polymorphisms of CYP2C19 gene will be detected by real time PCR
The frequency of the genetic polymorphisms of SLC22A16 in breast cancer patients
时间窗: up to 24 week
the blood samples will be DNA extracted by DNA extraction kit then single nucleotide polymorphisms of SL22A16 gene will be detected by real time PCR
次要结局
- Correlation between genetic polymorphisms of ABCB1 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy(up to 24 week)
- Correlation between genetic polymorphisms of SLC22A16 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy(up to 24 weeks)