JPRN-UMIN000002365已完成2 期
A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer (JBCRG 10) - JBCRG-10
Japan Breast Cancer Research Group (JBCRG)0 个研究点目标入组 103 人开始时间: 2009年8月31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
- 103
研究概览
简要总结
Results: TCH arm: pCR (ypT0/is) rate was 46% (n = 59). Overall response rate was 86%. Breast-conservation rate was 59%, and the proportion of patients who had been planned for mastectomy before PST but received breast-conserving surgery was 33% (9/27 patients). DFS and OS at 3 years were 96.6% and 98.3%, respectively. No significant difference was observed in DFS between the pCR (ypT0/is) and non-pCR groups (P = 0.87).
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. 11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 12)Multiple primary cancer or has history of multiple primary cancer in the past 5 years. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 13)History of invasive breast 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 agents. 16)Cardiac disorder diagnosed by echocardiography. 17)Women who are pregnant, lactating or with childbearing potential. 18)Ineligible based on decision of an investigator.
研究者
相似试验
暂停
不适用
A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrencenon-small-cell lung cancerNL-OMON27925VALT oncology864
招募中
不适用
A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small-cell lung cancer patients with high-risk for recurrence: NVALT 8Bon-small-cell lung cancerNL-OMON24423MCGHanzeplein 19700 RB Groningen600
进行中（未招募）
1 期
A study of Chemo only versus Chemo plus Nivo with or without BMS-986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS-986205 in Patients with MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004692-31-GRBristol-Myers Squibb International Corporation1,600
进行中（未招募）
1 期
A study of Chemo only versus Chemo plus Nivo with or without BMS-986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS-986205 in Patients with MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004692-31-ATBristol-Myers Squibb International Corporation1,600
进行中（未招募）
1 期
A study of Chemo only versus Chemo plus Nivo with or without BMS-986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS-986205 in Patients with MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004692-31-NLBristol-Myers Squibb International Corporation1,600