An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 主要终点
- Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
研究概览
简要总结
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 of age;
- •newly diagnosed;
- •infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.
排除标准
- •evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;
- •previous systemic or local primary treatment.
研究组 & 干预措施
HER2-NEU Positive
干预措施: capecitabine [Xeloda] (Drug)
HER2-NEU Positive
干预措施: Taxotere (Drug)
HER2-NEU Positive
干预措施: Herceptin (HER2-neu positive patients only) (Drug)
HER2-NEU Negative
干预措施: capecitabine [Xeloda] (Drug)
HER2-NEU Negative
干预措施: Taxotere (Drug)
结局指标
主要结局
Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
时间窗: at the time of definitive surgery; after four 3-week cycles (3-4 months)
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.
次要结局
- Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery(at the time of definitive surgery; after four 3-week cycles (3-4 months))
- Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))(post 2 and 4, 3-week cycles of treatment)
- Participants With Overall Survival(22 - 1191 days)
- Percentage of Participants With Local Recurrence(30 - 1102 days)
- Participants With Disease-Free Survival(30 - 1102 days)