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

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
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-04-01 至 2010-03-31

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中文摘要
翻译
这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者(PI)可能从另一个NIH来源获得主要资金, 因此可以在其他CRISP条目中表示。所列机构为 研究中心,而研究中心不一定是研究者所在的机构。 这是ECOG方案。本研究的目的是评价紫杉醇与曲妥珠单抗联合给药作为HER-2过表达的淋巴结阳性乳腺癌患者辅助治疗的一部分的顺序。 本研究将比较辅助阿霉素(ADR)和环磷酰胺(CTX)每3周一次,持续4个周期,随后紫杉醇(TAXOL)每周一次单独给药,持续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。随后是曲妥珠单抗治疗9个月,而曲妥珠单抗治疗方案在Paclitaxel治疗完成后开始治疗,持续12个月。
英文摘要
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.
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