ECOG PACCT-1: TRIAL ASSIGNING INDIVIDUALIZED OPTIONS FOR TREATMENT

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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.