STUDY OF STANDARD DOXORUBICIN AND CYCLOPHOSPHAMIDE IN ADVANCED BREAST CANCER

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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. 1. To compare the microscopic pathologic response rates in patients with inflammatory and estrogen-receptor negative locally advanced breast cancer treated with weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support to that in patients treated with teh "standard" doxorubicin and cyclophosphamide regimen given every three weeks. 2. To compare the toxicities of these two regiments. 3. To compare the delivered dose intensity of these two regimens. 4. To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients. 5. To estimate the incidence of early genetic damage during the course of treatment using two general clonal assays: a) the HUMARA (human androgen receptor assay) to screen for the presence of clonal hematopoiesis, and b) microsatellite instability (MSI) assays to screen for the presence of defective DNA mismatch repair mechanisms and loss of heterozygosity, in pretreatment blood and three sequential post-treatment specimens in breat cancer patients enrolled in this study. 6. To estimate the incidence of MLL (myelooid lymphoid leukemia) gene fusion transcripts and the frequency of RAS gene mutations (H-, K-, and N-RAS) in cases where either the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis.