This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a protocol studying locally advanced breast cancer (LABC) with the goal of understanding the progression of cancer from local disease to metastasis. LABC will be studied to see whether disease that responds to concurrent Paclitaxel and radiation is genetically, immunologically or molecularly distinct from that which is unresponsive and progresses to metastatic disease. The study will broadly study behavioral, cultural, epidemiological (including risk factors), genetic, immunological, molecular and (possibly) ethnic aspects of the disease. Three hundred patients will be enrolled, 100 at NYU and others in South Africa and Mexico. Individuals enrolled in the trial will have samples collected that will be used for both diagnostic and subsequent pathological, genomic and molecular biological purposes. Consent is requested for specimen collection and banking for subsequent use. The study is motivated by the observation that the pathological response to primary chemotherapy is emerging as a surrogate endpoint for survival. LABC provides a good opportunity to study the biological correlates of disease progression to metastasis, since shedding of cells into the circulation is documented in LABC, but this is not sufficient to trigger the development of remote disease. A study of the response of the local tumor to chemotherapy and radiation is expected to help evaluate subsequent treatment tailored to the tumor characteristics. LABC is a 'disease of the underserved,' with disadvantaged individuals likely to delay seeking (or finding access to) help until the disease has progressed. International sites for this study provide access to populations that fall into this category and permit a broad range of potential factors in the disease to be studied. The molecular and genetic profiles of the tumors and surrounding tissues will hopefully provide a chance to study the transformation of the cell populations. Epidemiological and cultural information will permit diagnosis and treatment strategies appropriate for different populations.
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