Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.
研究概览
简要总结
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.
详细描述
Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.
Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.
Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.
Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.
Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have histologically or cytologically confirmed breast cancer
- •No metastatic disease
- •Prior lumpectomy or mastectomy
- •No prior chemotherapy or hormone treatments for breast cancer
- •Must have normal organ and marrow function.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
排除标准
- •Peripheral neuropathy of grade II or higher.
- •History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
- •History of unstable angina or myocardial infarction within the last six months.
- •Pregnant or nursing women.
- •Known allergies to polysorbate
- •HIV-positive patients.
研究组 & 干预措施
Arm A (Docetaxel before doxorubicin/cyclophosphamide)
Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
干预措施: Docetaxel (Drug)
Arm A (Docetaxel before doxorubicin/cyclophosphamide)
Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
干预措施: Doxorubicin (Drug)
Arm A (Docetaxel before doxorubicin/cyclophosphamide)
Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
干预措施: Cyclophosphamide (AC) (Drug)
Arm B (Docetaxel after doxorubicin/cyclophosphamide)
"A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
干预措施: Docetaxel (Drug)
Arm B (Docetaxel after doxorubicin/cyclophosphamide)
"A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
干预措施: Doxorubicin (Drug)
Arm B (Docetaxel after doxorubicin/cyclophosphamide)
"A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
干预措施: Cyclophosphamide (AC) (Drug)
结局指标
主要结局
Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.
时间窗: up to 8 weeks
Docetaxel before doxorubicin/cyclophosphamide(AC)or Docetaxel after AC. The regimen selection will be based on the proportion of patients receiving four cycles of Docetaxel with no dose reductions within 10 weeks.
次要结局
- Determine the toxicities of Docetaxel administered before or after doxorubicin/cyclophosphamide(AC).(up to 5 years)