JPRN-UMIN000003570已完成2 期
A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer (JBCRG-13) - JBCRG-13
Japan Breast Cancer Research Group (JBCRG)0 个研究点目标入组 41 人开始时间: 2010年5月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
Results: pCR was achieved after mPCX and FEC by 47.5 % (19/40) of patients in the ITT population and in 54.5% (18/33) of patients in the PPS. The clinical response rate was 90.0% (36/40) in the ITT population and 93.9% (31/33) in the PPS. Breast conservation surgery was possible in six patients (40%) who were scheduled to undergo total mastectomy. Conclusion: Metronomic PCX followed by FEC chemotherapy was associated with a high pCR rate and low toxicity in patients with TNBC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) Prior chemotherapy or endocrine therapy in the past 5 years. 2) Active double cancer. 3) Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 4) Male patient. 5) Infection or suspected infection. 6) Serious cardiac disorder or preexisting cardiac disease. 7) Uncontrolled diabetes. 8) Gastrointestinal ulceration or gastrointestinal bleeding. 9) Other serious complication. 10) History of drug-hypersensitivity 11) Ineligible based on decision of an investigator.
研究者
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