A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Overall Clinical Response Rate (OCR)
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery.
The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
- •Ability to provide written informed consent prior to study-specific screening procedures
- •TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
- •Age 18 years or older
- •Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
- •Performance status 0-1
- •Required Initial Laboratory Data:
- •Granulocytes >=1,200/µl
- •Platelet count >=100,000/µl
- •Calculated Creatinine Clearance > 30 mL/min
- •Total bilirubin <= Upper Limit Normal
- •Alkaline Phosphatase <=Upper Limit Normal
- •SGPT, SGOT <=Upper Limit Normal
- •Normal chest x-ray
排除标准
- •HER2 positive breast cancer
- •Pregnant or lactating woman
- •Life expectancy < 3 months
- •Serious, uncontrolled, concurrent infection(s)
- •Any prior fluoropyrimidine therapy or other chemotherapy
- •Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
- •Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
- •Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
- •Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- •Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
- •Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- •Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
- •Any of the following laboratory values:
- •Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L)
- •Impaired renal function (estimated creatinine clearance <30ml/min as calculated with Cockcroft-Gault equation)
- •Serum bilirubin > upper normal limit.
- •SGOT, SGPT > upper normal limit
研究组 & 干预措施
Capecitabine
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall Clinical Response Rate (OCR)
时间窗: After the first three cycles of therapy, an average of 9 weeks
Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Partial Clinical Response Rate (PR)
时间窗: After the first three cycles of therapy, an average of 9 weeks
Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Complete Clinical Response Rate (CCR)
时间窗: After the first three cycles of therapy, an average of 9 weeks
Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.
Complete Pathologic Response Rate (cPR)
时间窗: After the first three cycles of therapy, an average of 9 weeks
Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.
次要结局
未报告次要终点