Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 11
- 主要终点
- Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
研究概览
简要总结
The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
详细描述
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.
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
- •Histologically or cytologically confirmed breast carcinoma.
- •Early stage breast cancer (stage 1, 2, 3).
- •No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- •18 years of age or older.
- •Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
排除标准
- •Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
- •Major surgery within 28 days of study entry.
- •Evidence of central nervous system (CNS) metastases.
- •Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
研究组 & 干预措施
Sequential Therapy
Docetaxel will be given at 100mg/m^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
干预措施: Docetaxel (Drug)
Sequential Therapy
Docetaxel will be given at 100mg/m^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
干预措施: Capecitabine (Drug)
Concurrent Therapy
Docetaxel will be given at 50mg/m^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
干预措施: Docetaxel (Drug)
Concurrent Therapy
Docetaxel will be given at 50mg/m^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
干预措施: Capecitabine (Drug)
结局指标
主要结局
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
时间窗: 1 year
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or \<25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
次要结局
- Long Term Follow up Data on Recurrence and Survival(2 years)