JPRN-UMIN000003283已完成2 期
A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer JBCRG-09 - JBCRG-09
Japan Breast Cancer Research Group (JBCRG)0 个研究点目标入组 195 人开始时间: 2010年3月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
研究概览
简要总结
pCR (CpCR + ypN0) rates were 9.2%, 8.1%, and 15.9% in the FEC-TC, TC-FEC, and TC6 groups, respectively. ORRs were 72.8% in the FEC-TC group (CR 12.3%), 73.0% in the TCFEC group (CR 4.8%), and 75.4% in the TC6 group (CR15.4%). pCR rates in the three groups were similar, but the breast conservation rate was significantly higher in the TC6 group than in the others.
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)Hypersensitivity to any agents necessary in the planned treatment. 2)Poorly controlled complication (malignant hypertension, myocardial infarction within 6 months, congestive heart failure, coronary insufficiency, arrhythmia which requires treatment, infection and bleeding). 3)Fever with suspected infection. 4)Symptoms of varicella. 5)Pleural effusion or cardiac effusion which requires treatment. 6)Serious edema. 7)Serious peripheral neuropathy 8)Complication which requires prior treatment with corticosteroid. 9)Regular use of H2 blocker. 10)Has history of or receiving treatment for serious psychiatric disorder case. 11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 12)History of invasive breast cancer. 13)Multiple primary cancer .However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 14)History of multiple primary cancers in the past 5 years, excluding nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer appropriately treated. 15)Prior treatment with anticancer case. 16)Women who are pregnant, lactating or with childbearing potential. 17)Ineligible based on decision of an investigator.
研究者
相似试验
已完成
2 期
Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03)Operable breast cancerJPRN-C000000291Japan Breast Cancer Research Group (JBCRG)137
已完成
2 期
A randomized phase II study of TEC (Paclitaxel+Epirubicin+Carboplatin) therapy, TAC (Paclitaxel+Doxorubicin+Carboplatin)therapy, and ddTC (Dose-dense Paclitaxel+Carboplatin) therapy as adjuvant chemotherapy for the patients with intermediate or high risk group of endometrial carcinomaEndometrial carcinomaJPRN-UMIN000008911intergroup/GOGO105
终止
3 期
Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast CancerBreast CancerNCT00912444Shanghai Jiao Tong University School of Medicine102
未知
2 期
A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancerBreast cancerJPRN-UMIN000000493Japan East Cancer Center Breast Cancer Consortium50
已完成
3 期
Minus Anthracycline or Short-Term Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel Regimen for Adjuvant Breast Cancer TherapyPrimary Breast CancerNCT01314833Fudan University1,570