NCT03221881已完成不适用
The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PCR rate
研究概览
简要总结
In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed breast cancer;
- •Age >18 years;
- •Eastern Cooperative Group (ECOG) performance status 0-2;
- •measurable disease (as per radiological imaging); life
- •expectancy >12 months;
- •adequate haematologic blood profile;
- •normal liver and kidney function;
- •adequate cardiac function;
- •no metastatic disease;
- •negative pregnancy test (premenopausal women);
- •signed informed consent.
排除标准
- •Level 2 cardiac toxic effects were defined as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ;
- •Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures);
- •Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;
研究组 & 干预措施
Pegylated Liposomal Doxorubicin and docetaxel
Experimental
Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.
干预措施: Pegylated Liposomal Doxorubicin and docetaxel (Drug)
结局指标
主要结局
PCR rate
时间窗: 12 months
pathologic complete response rate
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Pegylated Liposomal Doxorubicin Combined With Anlotinib for Neoadjuvant Treatment of Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaNCT04765228Yong Chen45
已完成
2 期
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast CancerBreast CancerNCT01206881Herlev Hospital45
Unknown
不适用
Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer PatientsLiposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer PatientsNCT05181202Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University20
撤回
2 期
A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With BortezomibMultiple MyelomaNCT00706953Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
已完成
不适用
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast CancerBreast CancerNCT00656669Indiana University23