CLINICAL TRIAL: P III TRIAL OF DOXORUBICIN & CYCLOPHOSPHAMIDE FOL BY WEEKLY PACL

临床试验：阿霉素 P III 试验

• 批准号: 7951358
• 负责人: Witold B. Rybka
• 金额: $ 0.74万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951358
• 关键词: Adjuvant; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cyclophosphamide; Doxorubicin; ERBB2 gene; Eastern Cooperative Oncology Group; Funding; Grant; Institution; Paclitaxel; Patients; Positive Lymph Node; Protocols documentation; Research; Research Personnel; Resources; Source; Toxic effect; Trastuzumab; United States National Institutes of Health; comparative efficacy; malignant breast neoplasm; overexpression; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an ECOG protocol. The purpose of this study is to evaluate the sequencing of paclitaxel administration with trastuzumab as part of the adjuvant treatment of patients with node positive breast cancer whose tumors overexpress HER-2. This study will compare the efficacy and toxicity of adjuvant doxorubicin (ADR) and cyclophosphamide (CTX) every three weeks for four cycles followed by paclitaxel (TAXOL) administered weekly for twelve weeks alone versus this regime with trastuzumab (HERCEP) to be started concurrent with paclitaxel. Followed by trastuzumab for nine months versus this regime with trastuzumab started after the completion of Paclitaxel and continuing for twelve months.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项ECOG协议。本研究的目的是评价紫杉醇与曲妥珠单抗联合给药的顺序，作为肿瘤过度表达HER-2的结节阳性乳腺癌患者辅助治疗的一部分。这项研究将比较佐剂阿霉素(ADR)和环磷酰胺(CTX)每三周一次，共四个周期，然后每周单独给予紫杉醇(紫杉醇)12周与曲妥珠单抗(HERCEP)与紫杉醇同时开始的方案的疗效和毒性。随后曲妥珠单抗与这个方案进行了9个月的对比，曲妥珠单抗在紫杉醇完成后开始，持续了12个月。