NCT00148720终止2 期
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.
详细描述
- Prior to the start of treatment, patients will have a small metal clip inserted into the tumor bed to identify the tumor site to the surgeon. At that time, a needle biopsy of the breast tumor or a sentinel (underarm) lymph node biopsy will also be performed.
- Patients will take capecitabine orally twice daily for 14 days. This treatment will repeat every 21 days (1 cycle). Patients will receive 4 cycles of this treatment.
- A physical exam and blood work will be done every three weeks after starting therapy to monitor side effects.
- After two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine.
- After completing 4 cycles (12 weeks) of capecitabine, patients will then undergo surgery to remove any remaining breast cancer (lumpectomy or mastectomy). Post-surgical treatment (radiation, chemotherapy, and hormonal therapy) is at the discretion of the patients physician.
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
- •Histological confirmation of primary invasive breast cancer
- •Stage I-III operable breast cancer.
- •Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
- •Women greater than 18 years of age
- •ECOG performance status 0-1
- •WBC > 4000/mm3
- •Platelet count > 100,000/mm3
- •SGOT < 2x ULN
- •Calculated creatinine clearance > 50ml/min
排除标准
- •Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.
- •Pregnant or breast-feeding women
- •Inflammatory breast cancer
- •HER2 positive disease
- •History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Uncontrolled intercurrent illness
- •Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
- •Excisional biopsy performed prior to enrollment
- •Uncontrolled coagulopathy
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
结局指标
主要结局
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
时间窗: 3 years
次要结局
未报告次要终点
研究者
Ian E. Krop, MD, PhD
Assistant Professor of Medicine
Dana-Farber Cancer Institute
研究点 (6)
Loading locations...
相似试验
终止
2 期
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast CancerBreast CancerNCT00347438University of Chicago18
进行中（未招募）
1 期
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast CancerBreast CancerNCT03377387Memorial Sloan Kettering Cancer Center34
已完成
1 期
Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical ModelBreast CancerNCT00468585Memorial Sloan Kettering Cancer Center62
尚未招募
2 期
Capecitabine in HER-2 Positive Breast Cancer With Pathologic Residual Tumors After Preoperative ChemotherapyHER2-positive Breast CancerNCT03684863Shandong Cancer Hospital and Institute200
已完成
2 期
Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal CancerRectal CancerNCT01043484Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)90