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 a Phase 2, nonrandomized study of primary chemotherapy with gemcitabine plus epirubicin plus paclitaxel (GET) in patients with locally advanced breast cancer. The primary aims of this study are to determine the clinical and pathologic response rate and evaluate the toxicity of this combination. Gemcitabine will be administered intravenously on days 1 and 4. Epirubicin will be administered as an intravenous bolus on day 1. Paclitaxel will be administered as a 3-hour infusion on day 1. The cyle will be repeated every 21 days. Treatment will be administered until disease progression, or a maximum of 6 cycles. Patients who acheive clinical complete response (cCR), partial response (PR), or stable disease (SD) will undergo surgery. Tumor samples taken prior to treatment and at surgery will be analyzed for molecular and genetic changes and will be correlated with tumor response. Treatment may be stopped at any time at the discretion of the treating physician or the patient. Treatment should be stopped in any case of intolerable toxicity or progressive disease (PD). Patients must have a hitologically confirmed diagnosis of breast cancer without evidence of metastatic disease. Patients must have Stage IIB (T3), IIIA, or IIIB breast cancer or Stage IV (with involvement of supraclavicular nodes only) determined by physical exam, mammography, sonogram, MRI, x-ray, or CT scan. Patients with inflammatory breast cancer or superficial lesions with a measurable mass in the breast or lymph node are eligible. The sample size for this study, 76 patients, was chosen to satisfy requirements of confidence interval width. Specifically, it was desired that the 95% confidence interval around an anticipated pathological CR rate of 15% should be completely bounded within the interval 0.05 to 0.25. That is, if the observed CR rate is 15%, the confidence interval bounds should be no farther than 0.10 in either direction from the observed rate.
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