ECOG PACCT-1: TRIAL ASSIGNING INDIVIDUALIZED OPTIONS FOR TREATMENT

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。 这项研究涉及到一种名为Oncotype DX(基因组健康公司，加利福尼亚州雷德伍德)的新诊断测试的使用。这项测试涉及对受试者在手术过程中已经进行的癌症的分析，并已存储在病理实验室，这是一种常规程序。分析将完成，以测量肿瘤中一组特定基因的水平。进行这项检测的实验室(基因组健康实验室)已获得美国联邦和州机构的认证，可以进行这种检测(Oncotype DX)。测试结果被计算成分数(重复分数)。初步研究结果显示，肿瘤可分为以下几类： 二次研究组-1(复发评分10分)：如果只接受激素治疗，这一组在10年内其他器官乳腺癌复发的可能性为5%或更低。在这一组中，化疗尚未被证明能降低复发风险。大约25%的患者肿瘤复发评分为10分。 二次研究组-2(复发评分26)：如果接受激素治疗，这一组在10年内有大约30%的机会复发其他器官的乳腺癌。在这组患者中，化疗将复发风险降低了约75%。换句话说，在这组人中，加上化疗会增加10年内无疾病复发的机会，从大约70%增加到大约90%。大约35%的患者有肿瘤复发评分为26分。 初级研究组(复发评分11-25)：如果接受激素治疗，这一组在10年内有大约10%的机会复发其他器官的乳腺癌。在这一组中，尽管复发风险高到足以建议考虑化疗，但尚不清楚化疗是否降低了复发风险，以及总体健康益处是否有利于使用化疗。大约40%的患者有肿瘤复发评分在11-25之间。 之所以进行这项研究，是因为化疗通常被推荐用于疾病的治疗，以降低乳腺癌复发的风险。这项研究的目的是确定肿瘤型DX复发评分为11-25的肿瘤患者是否从化疗中受益，并确认肿瘤型DX复发评分为&lt；10的患者单独使用激素治疗的复发风险非常低(并且不需要通过化疗来降低复发风险)。另一个目标是建立一个组织和血液标本库，其中包括参与这项研究的所有妇女的标本，并收集关于所有参与研究的妇女的健康状况的后续信息。这将使研究人员能够在未来评估新的诊断测试，因为它们可能预测某些治疗的益处或副作用。 大约10,000名患有乳腺癌的妇女将参加这项研究。纽约大学GCRC将对5名受试者进行研究。

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 study involves the use of a new diagnostic test called the Oncotype DX (Genomic Health, Inc, Redwood, CA). This test involves analysis of cancer that has already been taken during subjects' surgery and has been stored in the pathology laboratory, a routine procedure. Analysis will be completed to measure the levels of a specific panel of genes in the tumor. The laboratory that performs this test (Genomic Health laboratory) has been certified by federal and state agencies in the United States to perform the test (Oncotype DX). The results of the test are computed into a score (Recurrence Score). The results from initial studies indicate that tumors may be classified into the following groups: Secondary Study Group-1 (Recurrence Score < 10): This group has a 5% or less chance of having a relapse of breast cancer in other organs at 10 years if treated with hormonal therapy alone. In this group, chemotherapy has not been proven to reduce the risk of recurrence. Approximately 25% of patients have a tumor with a Recurrence Score of < 10. Secondary Study Group-2 (Recurrence Score > 26): This group has about a 30% chance of having a relapse of breast cancer in other organs at 10 years if treated with hormonal therapy. In this group, chemotherapy reduced the risk of recurrence by about 75%. In other words, adding chemotherapy increases the chance of being without disease recurrence at 10 years from about 70% to about 90% in this group. About 35% of patients have a tumor with a Recurrence Score of > 26. Primary Study Group (Recurrence Score 11-25): This group has about a 10% chance of having a relapse of breast cancer in other organs at 10 years if treated with hormonal therapy. In this group, although the risk of recurrence is high enough to recommend consideration of chemotherapy, it is unknown whether chemotherapy reduces the risk of recurrence and whether the overall health benefits favor the use of chemotherapy. About 40% of patients have a tumor with a Recurrence Score of 11-25. This study is being done because chemotherapy would normally be recommended for the treatment of disease to lower the risk of breast cancer recurring. The purpose of this study is to determine whether patients who have a tumor with an Oncotype DX Recurrence Score of 11-25 benefit from chemotherapy, and to confirm that patients who have Oncotype DX Recurrence Score of < 10 have a very low risk of recurrence with hormonal therapy alone (and do not need chemotherapy to reduce their risk of recurrence). Another objective is to create a tissue and blood specimen bank that includes specimens from all women who participate in this study, and to collect follow-up information regarding the health status of all women who participate in the study. This will allow researchers to evaluate new diagnostic tests in the future as they develop that may predict benefit or side effects from certain treatments. Approximately 10,000 women with breast cancer will take part in this study. 5 subjects will be studied on the NYU GCRC.