Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy
研究概览
简要总结
In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine
详细描述
Patients with operable, primary invasive non inflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy then underwent adjuvant treatment with gemcitabine plus cisplatin Patients will be followed up every 3 month in first year then every 6 month in the second year then followed up yearly Study will be conducted at Assiut University Hospital with sample size calculation BRACA will be done
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
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20 years and older.
- •Patients with no clinical/radiologic distant metastasis.
- •Tumor type: Invasive ductal carcinoma or invaive lobular carcinoma.
- •Tumor subtype: triple negative
- •patients had operable, primary invasive, noninflammatory early stage I-IIIB TNBC (ER and PR <1%, HER2 score: 0 or 1)
- •Patients with a good performance status (0/1)
- •Patients with adequate hematological, cardiac, renal, and hepatic function
排除标准
- •Patients who achieve pathologic complete response after neoadjuvant chemotherapy
- •inflammatory breast cancer
- •Breast cancer patients with distant metastasis
- •Patient with hormonal receptor positive /HER2 +ve
研究组 & 干预措施
cisplatin and gemicitabine
patients with triple negative breast cancer will recieve adjuvant cisplatin and gemicitabine in non pathological complete response after neo-adjuvant standard chemotherapy with dose of cisplatin 70mg/m2 at day one and gemicitabine 1000mg/m2 day one and day eight every 21 day for six cycle
干预措施: Cisplatin injection and gemcitabine (Drug)
capecitabine
patients with triple negative breast cancer will recieve adjuvant capecitabin in non pathological complete response after neo-adjuvant standard chemotherapy with dose of capecitabine 1000-1250 mg/m2 every 21 day for six cycle
干预措施: Capecitabine tablets (Drug)
结局指标
主要结局
Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy
时间窗: 2 years
2 years disease free survival which is calculated since time of surgery till occurance of local or distant recurrence
次要结局
- Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer(3 years)
研究者
Sohaila Essam Mohamed
Assiut university Hospital
Assiut University