An Open, Randomized, Parallel-group, Multicenter Clinical Study to Evaluate Efficacy and Safety of Paclitaxel Every 2 Weeks Compared Weekly in Adjuvant Treatment of Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- disease-free survival
研究概览
简要总结
RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse and death in women with operable breast cancer.In the North American Inter-Group factorial trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals (supported by the use of granulocyte-colony stimulating factor) were better than the conventional inconvenient weekly intervals.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years female operable breast cancer patients
- •Patients were required to register within 60 days from the final surgical procedure required to adequately treat the invasive primary tumor.
- •women who had operable,histologically confirmed adenocarcinoma of the breast with a. histologically involved positive lymph nodes b. or histologic diagnosis for three negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH (fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification is positive),but unable or intolerant to herceptin combined chemotherapy.
- •Karnofsky points greater than or equal to
- •Postmenopausal women or HCG test results were negative, Women of child-bearing potential willing to use effective contraception during the study.
- •PATIENT CHARACTERISTICS:
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal
- •TBIL no greater than 1.5 times upper limit of normal
- •AKP no greater than 2.5 times upper limit of normal
- •AST no greater than 2.5 times upper limit of normal
- •ALT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 times upper limit of normal
- •Cardiovascular:
- •No history of myocardial infarction
- •No congestive heart failure
- •No significant ischemic or valvular heart disease
- •No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
- •Other protocol-defined inclusion/exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
EC-P2
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 2-week intervals for 4 cycles.
干预措施: paclitaxel (Drug)
EC-P1
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 1-week intervals for 12 cycles.
干预措施: paclitaxel (Drug)
结局指标
主要结局
disease-free survival
时间窗: 3 years
time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer.
次要结局
- disease-free survival(5 years)
- overall survival(5 years)
研究者
Feilin Cao
MD
Taizhou Hospital