NCT01220076已完成2 期
Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+
Institut Cancerologie de l'Ouest3 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
研究概览
简要总结
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.
The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult Females (≥ 18 years), with effective contraception. The contraceptive should not use estrogen to a derivative. It must be continued during treatment with tamoxifen for at least two months after his arrest.
- •Histologically confirmed diagnosis of invasive breast cancer, previously untreated. Patients have been supported for a breast cancer may be included if a period of at least 2 years between the last systemic treatment of inclusion in the study.
- •Primary tumor hormonopositive: ER and / or PR ≥ 50% by immunohistochemistry.
- •Lack of HER2 overexpression
- •Palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound
- •Patient scheduled to undergo breast cancer surgery
- •No metastases
- •Clinical Stage M0
- •Performance index ≤ 1 (OMS)
- •Neutrophils WBC > or = 1500 / mm3, Platelets > or = 100 000/mm3 Hemoglobin ≥10 g/dL
- •Normal liver function: bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases).
- •Normal renal function (creatinine ≤ 1.5 mg / dL or creatinine clearance ≥ 60 mL / min)
- •Cardiac function (MUGA scan or ultrasound February> 55%) and lung function, 5.2.2 Criteria related to participation in the study:
- •Patient affiliated to social security, Patient has signed and dated consent
- •Non-Inclusion Criteria:
- •Pregnant or Breastfeeding women
- •Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment
- •Consumption of grapefruit juice in the last 5 days of starting treatment
- •Congenital galactosemia
- •Glucose and galactose malabsorption
- •Lactase deficiency
- •Co-medications that may interfere with cytochrome P450:
- •Ongoing Enzyme inducers:
- •Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
- •Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz
- •Ongoing Enzyme Inhibitors:
- •Inhibitors of serotonin reuptake: fluoxetine, paroxetine
- •Thioridazine. Quinidine
- •Amiodarone
- •Ca antagonists: diltiazem, verapamil
- •azole antifungals ketoconazole, fluconazole, miconazole.
- •No protease inhibitors: ritonavir, nelfinavir, amprenavir, indinavir.
- •Macrolides: erythromycin, clarithromycin, josamycin
排除标准
- 未提供
研究组 & 干预措施
Tamoxifene
Experimental
干预措施: tamoxifen (Drug)
结局指标
主要结局
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
时间窗: 5 weeks
The primary endpoint is the determination of the variation in the KI-67 expression, a marker of cell proliferation, at the tumour level between the initial biopsy (T0) and after 5 weeks of tamoxifen treatment, in relation to cytochrome 2D6 polymorphisms. A 50% geometric reduction in KI-67 expression at 5 to 7 weeks should be considered as a major response
次要结局
未报告次要终点
研究者
研究点 (3)
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