NCT01732939Unknown不适用
Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer
Hospital Affiliated to Military Medical Science, Beijing1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pathological complete response rate
研究概览
简要总结
The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.
详细描述
The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of invasive ductal or lobular breast cancer.
- •Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
- •no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
- •Performance Status ECOG <2
- •Age > 18 years
- •Tumor > 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky >50%
- •Lab test :
- •Absolute neutrophil count > 1,500/mm3
- •Total Bilirubin ≤ 2×ULN
- •AST and ALT ≤ 2.5×ULN
- •serum creatinine ≤ 1.5×ULN
排除标准
- •Pregnant or breast feeding patients are excluded
- •stage Ⅳ breast cancer
- •History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
- •uncontrolled cardiac disease
- •Active infection or chronic infection requiring chronic suppressive antibiotics
- •History of hypersensitivity reaction to investigating drugs
结局指标
主要结局
pathological complete response rate
时间窗: one year
次要结局
- clinical response rate, safety(one year)
研究者
研究点 (1)
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