Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx, Doxil) for Women (Age 66 Years or Older) With Endocrine Nonresponsive Breast Cancer Who Are Not Suitable for Being Offered a " Standard Chemotherapy Regimen"
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 33
- 主要终点
- Breast cancer free interval by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the breast cancer-free interval in elderly women with resectable, hormone receptor-negative breast cancer treated with pegylated doxorubicin hydrochloride liposome (PDL) vs observation or PDL vs cyclophosphamide and methotrexate.
Secondary
- Compare the tolerability of these regimens in these patients.
- Compare the safety and toxic effects of these regimens in these patients.
- Compare the overall and progression-free survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the sites of failure in patients treated with these regimens.
- Compare the competing causes of death in patients treated with these regimens.
- Compare the rate of second non-breast malignancy in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 66 Years 至 120 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CASA-nil PLD
Adjuvant pegylated liposomal doxorubicin (PLD) for 16 weeks
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
CASA-nil PLD
Adjuvant pegylated liposomal doxorubicin (PLD) for 16 weeks
干预措施: adjuvant therapy (Procedure)
CASA-nil PLD
Adjuvant pegylated liposomal doxorubicin (PLD) for 16 weeks
干预措施: radiation therapy (Radiation)
CASA-Nil
No adjuvant therapy
干预措施: radiation therapy (Radiation)
CASA-CM PLD
Adjuvant pegylated liposomal doxorubicin (PLD) for 16 weeks
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
CASA-CM PLD
Adjuvant pegylated liposomal doxorubicin (PLD) for 16 weeks
干预措施: adjuvant therapy (Procedure)
CASA-CM PLD
Adjuvant pegylated liposomal doxorubicin (PLD) for 16 weeks
干预措施: radiation therapy (Radiation)
CASA-CM CM
Low-dose, metronomic cyclophosphamide and methotrexate (CM) for 16 weeks
干预措施: cyclophosphamide (Drug)
CASA-CM CM
Low-dose, metronomic cyclophosphamide and methotrexate (CM) for 16 weeks
干预措施: methotrexate (Drug)
CASA-CM CM
Low-dose, metronomic cyclophosphamide and methotrexate (CM) for 16 weeks
干预措施: adjuvant therapy (Procedure)
CASA-CM CM
Low-dose, metronomic cyclophosphamide and methotrexate (CM) for 16 weeks
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Breast cancer free interval by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment
时间窗: 5 years after recruitment starts
次要结局
- Adverse events assessed by CTCAE v3.0 every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually after completion of study treatment(5 years after recruitment starts)
- Quality of life assessed by Casa QL form, Mini-Cog, and VES-13 at baseline and at 2, 6, and 12 months after completion of study treatment(5 years after recruitment starts)
- Disease-free survival by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment(5 years after recruitment starts)
- Overall survival by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment(5 years after recruitment starts)
- Sites of failure by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment(5 years after recruitment starts)
- Second (non-breast) malignancy by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment(5 years after recruitment starts)
- Causes of death prior to breast cancer recurrence by physical examination, laboratory tests, and investigations every 2 wks for 16 wks during treatment, every 3-6 mo. for 5 yrs, then annually as indicated after completion of study treatment(5 years after recruitment starts)