JPRN-jRCTs051180210招募中3 期
Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy - Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy (JONIE4/JCaT)
Kunihisa Tomonari0 个研究点目标入组 162 人开始时间: 2019年3月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- Female
入选标准
- •(1) Triple negative breast cancer patients
- •i) ER and PgR negative (IHC<10 %)
- •ii) HER2 negative (IHC 1+/0 or IHC 2+/FISH-)
- •(2) Patients who received Anthracycrine and Taxan treatment preoperatively received standard surgery.
- •(3) Patients with residual invasive cancer or lymph node metastasis on surgical specimens
- •(4) Within 4 months after surgery
- •(5) 20<= and <80 years old
- •(6) Written consent
排除标准
- •(1) ER >=10 % or HER2 positive on surgical specimen
- •(2) previously treated with Carboplatin
- •(3) other cancer treated within 5 years, history of breast cancer and bilateral breast cancer
- •(4) severe myelosuppression
- •(5) sever hypersensitivity for platinum containing drugs including Carboplatin
- •(6)during pregnancy or breast feeding
- •(7) attended clinical trial within 6 month
- •(8) metastatic breast cancer
- •(9) heavy disorder of heat, kidney or liver
- •(10) doctor's dicision of inadequacy
研究者
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