Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- progression free survival assessed by imaging procedures
研究概览
简要总结
Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.
详细描述
Breast cancer is the most common malignancy of females. In Germany about 46,000 women come down with breast cancer yearly.
Present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. It is therefore necessary to test new substances and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease.
Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity.
Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. It is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >/= 18 years with histologically proven metastatic breast cancer
- •No prior chemotherapy in the advanced situation
- •ECOG </= 2
- •Adequate bone marrow reserve
- •left ventricular ejection fraction (LVEF) >/= 50, measured within 4 weeks before study treatment
- •Existence of written informed consent
排除标准
- •Previous high dose therapy with stem cell support
- •Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone
- •Concomitant hormon- or chemotherapy or radiation therapy
- •Her2/neu overexpression
- •pregnancy or breast feeding
研究组 & 干预措施
Myocet/Paclitaxel
20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
干预措施: liposomal Doxorubicin (Drug)
Myocet/Paclitaxel
20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
干预措施: Myocet / Paclitaxel (Drug)
结局指标
主要结局
progression free survival assessed by imaging procedures
时间窗: after 6 weeks, 12 weeks, 18 weeks
次要结局
- toxicity, quality of life(every 3 weeks)
- response rate, overall survival(28 d after last Chemotherapy, up then every 3 months for 1 and a half year, and up then every 6 months until 5 years.)
研究者
Claudia Lorenz-Schlüter
member of CRO
University of Magdeburg