JPRN-jRCTs041180139已完成2 期
Feasibility study of dose dense chemotherapy for primary breast cancer patients - Feasibility study of dd-chemotherapy for primary breast cancer patients
Saito Kanako0 个研究点目标入组 30 人开始时间: 2019年3月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
Thirty breast cancer patients were treated with dose-dense chemotherapy. The completion rate was 76%. The completion rate was 88% in 26 patients, excluding 3 patient requests and 1 ineligible patient among the discontinued cases. The 3 discontinuations were due to liver dysfunction in 2 cases and pneumonia in 1 case; no cases of PCP pneumonia were observed. After the completion of enrollment, doxorubicin and paclitaxel were revised in the package inserts, and this treatment is now covered by insurance.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •1. Invasive ductal carcinoma
- •2. Stage I-III
- •3. Age >=20 and 75=<
- •4. ECOG PS 0 or 1
- •5. Vital organ functions are preserved
- •6. Written IC
排除标准
- •1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
- •2. History of drug-related allergy which could hinder planned treatment
- •3. Any history or complication of following cardiac disorders
- •- History of congestive heart failure, cardiac infarction
- •- Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
- •4. Poorly controlled hypertension
- •5. Poorly controlled diabetes
- •6. Pregnancy
- •7. Ineligible to the trial based on decision of an investigator
研究者
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