JPRN-UMIN000000843已完成3 期
A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy(JBCRG-04) - JBCRG-04(CREATE-X)
JBCRG (Japan Breast Cancer Research Group) KBCS(Korean Breast Cancer Society) KCSG(Korean Cancer Study Group)0 个研究点目标入组 910 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 910
研究概览
简要总结
RESULTS: DFS was longer in the capecitabine group than in the control group (74.1% vs. 67.6%). OS was longer in the capecitabine group than in the control group (89.2% vs. 83.6%). CONCLUSIONS: After standard neoadjuvant chemotherapy, the addition of adjuvant capecitabine therapy was safe and effective in prolonging DFS and OS among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1. The patient is considered to require postoperative chemotherapy other than capecitabine. 2. The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable). 3. The patient has either simultaneous or non-simultaneous bilateral breast cancer. 4. The Patients has or has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible. 5. The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding. 6. The patient has previously had an organ transplant. 7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane. 8. The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months. 9. The patient has a fever, and there is the possibility that she has an infection. 10. The patient has been shown to have metastasis to other organs. 11. The patient requires treatment for epilepsy and/or central nervous system disorders. 12. The patient is currently being treated for, or has a history of, psychiatric disease. 13. It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome. 14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.
研究者
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