Multicenter Phase IV.II Trial, for the Administration of Capecitabine Simultaneous to Radiotherapy for Local Relapse Breast Cancer Patients With Negative Her2 Tumours
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 7
- 主要终点
- Complete clinical response rate
研究概览
简要总结
This is a prospective, open-label, multicenter phase IV.II study. Patients with local relapse breast cancer will receive radiotherapy concomitant to the administration of capecitabine.
详细描述
Total dose of radiotherapy will be 50 Gy administered in daily session of 200 centigray (cGy). Radiotherapy treatment will not be longer than 6 weeks.
All patients will receive 1650 mg/m2 by mouth, per day (825 mg/m2 twice a day (p.o. bid) for 35 days.
Tissue samples must be analysed to determinate the human epidermal growth factor receptor-2 (HER2) by fluorescent in situ hybridization (FISH) technical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Histological diagnoses of operable invasive adenocarcinoma of the breast.
- •Patients with tumour HER2 negative.
- •Previous mastectomy surgery.
- •Actual diagnoses of local recurrence of breast cancer.
- •Patients must not present evidence of metastatic disease.
- •Age >= 18 years old.
- •Performance status (Karnofsky index) >=
- •Laboratory results (within 14 days prior to randomization):
- •Hematology:
- •neutrophils >= 1.5 x 10e9/l;
- •platelets >= 100x 10e9/l;
- •hemoglobin >= 10 mg/dl
- •Hepatic function:
- •total bilirubin <= 1,5 upper normal limit (UNL);
- •Alanine transaminase (SGOT) and aspartate aminotransferase (SGPT) <= 1.5 UNL;
- •alkaline phosphatase <= 1.5 UNL.
- •Renal Function:
- •creatinine <= 175 µmol/l (2 mg/dl)or creatinine clearance >= 60 ml/min.
排除标准
- •Distant metastasis or metastatic disease in organs.
- •Metastasis in internal mammary chain lymph nodes
- •Previous radiation treatment on the breast or other locations (30% or greater of the bone marrow).
- •Prior treatment with continuous (greater than 24h) 5-fluorouracil (5-FU) infusion, capecitabine or other oral fluoropyrimidines such as eniluracil/5-FU , uracil/tegafur, S1 or emitefur.
- •Known hypersensitivity to capecitabine, doxifluridine or any of its components.
- •Organ allografts that require an immunosuppressor therapy.
- •History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
- •Clinically significant cardiac disease such as congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication or history of myocardial infarction within the last 12 months or uncontrolled hypertension.
- •Evidence of central nervous system (CNS) metastases. Pts with a history of uncontrolled seizures, CNS disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance should be excluded from the study.
- •Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.
- •Active uncontrolled infection or other severe pathologies such as active peptic ulcer, unstable diabetes mellitus.
- •Major surgery during 4 weeks prior to treatment.
- •Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.
- •Anticoagulant treatment with coumadin anticoagulants.
- •Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.
- •Concomitant treatment with other therapy for cancer.
研究组 & 干预措施
Radiotherapy + Capecitabine
Radiotherapy (for 25 days; Dose: 50 Gy) + Capecitabine (for 35 days; Dose: 825 mg/m2 twice per day p.o.) Experimental treatment consists of administration of 825 mg/m2 x 2 daily p.o., for 7 days simultaneously with daily radiotherapy treatment.Capecitabine will be administered for 35 days as maximum.
干预措施: Capecitabine (Drug)
Radiotherapy + Capecitabine
Radiotherapy (for 25 days; Dose: 50 Gy) + Capecitabine (for 35 days; Dose: 825 mg/m2 twice per day p.o.) Experimental treatment consists of administration of 825 mg/m2 x 2 daily p.o., for 7 days simultaneously with daily radiotherapy treatment.Capecitabine will be administered for 35 days as maximum.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Complete clinical response rate
时间窗: 28 days after the end of the radiotherapy
The disease evaluation will be measured by RECIST criteria in the 28 days after the end of the radiotherapy by Magnetic resonance imaging (MRI).
次要结局
- Evaluation of the concomitant administration of capecitabine and radiotherapy as the first treatment(28 days after the end of the radiotherapy)