Effect of Capecitabine as Maintenance Therapy Versus Observation on Patients With Early Stage Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- adverse effents of capictabine
研究概览
简要总结
Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
详细描述
Eligible patients will randomly open label assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year.
Total follow up of the study is 2 years, one year for drug receving with monthy follow up for adverse effect and the other year for every 3 months follow up to asses DFS and OS.
Collection of capecitabine dose will receive and adverse events will assessed monthly during capecitabine maintenance in the capecitabine group. In both groups, physical examination, assessment of menopausal status, breast ultrasound, and abdominal ultrasound were performed every 3 months during 2 years of follow up; mammography and chest x-ray were performed yearly. Patients who has not experienced recurrence or death at the time of data analysis will censored as alive and event-free at the date of last follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Eligible trial participants will women who has pathologically confirmed invasive breast ductal carcinoma Hormone receptor negative (<1% positive cells by immunohistochemistry staining) and ERBB2 negative.
- •Participants had early-stage tumors that were stage T1b-3N0-3cM0, without positive supraclavicular or internal mammary lymph node.
- •They received standard treatments, including modified radical mastectomy or breast-conserving surgery, neo-/adjuvant chemotherapy, and radiotherapy according to institutional guidelines.
- •patients were able to swallow tablets
- •performance status 0 - 1
排除标准
- •Key exclusion criteria will include Inflammatory or bilateral breast cancer. History of invasive breast cancer or other malignancies; receipt of other biologic agents or immunotherapy.
- •Lactation or pregnancy; or severe coexisting illness.
研究组 & 干预措施
receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr
干预措施: capecitabine (Drug)
结局指标
主要结局
adverse effents of capictabine
时间窗: assess the adverse effects of the Capecitabine 6 months after starting treatment.
次要结局
- distant disease-free survival(up to 24 months from diagnosis)
- overall survival(24 months from diagnosis)
研究者
Sarah Hamdy Ali Sayed
assistant lecturer of clinical oncology
Beni-Suef University