Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 117
- 主要终点
- Pathological complete response rate by histologic evaluation at definitive surgery
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the rate of breast-conserving surgery in patients treated with this regimen.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the feasibility of drug administration, in terms of the percent of planned dose actually administered per course, in patients treated with this regimen.
- Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen.
- Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen.
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
- All
- 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
docetaxel + carboplatin + pegfilgrastim + surgery
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
干预措施: pegfilgrastim (Biological)
docetaxel + carboplatin + pegfilgrastim + surgery
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
干预措施: carboplatin (Drug)
docetaxel + carboplatin + pegfilgrastim + surgery
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
干预措施: docetaxel (Drug)
docetaxel + carboplatin + pegfilgrastim + surgery
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Pathological complete response rate by histologic evaluation at definitive surgery
时间窗: Up to 5.5 years
次要结局
- Toxicity profile by CTCAE v3.0 at baseline and each subsequent evaluation(Up to 5.5 years)
- Rate of breast conserving surgery at definitive surgery after neoadjuvant chemotherapy(Up to 5.5 years)
- Clinical response rate by clinical examination prior to definitive surgery(Up to 5.5 years)