positron emission tomography using 3'-deoxy-3'-(18f) fluorothymidine in treating women with locally advanced cancer in one breast who are receiving chemotherapy

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as positron emission tomography (pet) using 3'-deoxy-3'-(18f) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer. purpose: this clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18f) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.

objectives: primary * evaluate the efficacy of positron emission tomography (pet) utilizing 3'-deoxy-3'-(18f) fluorothymidine (\^18f-flt) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer. * correlate pet-\^18f-flt results with histological response. secondary * evaluate the correlation of early changes in tumor uptake of \^18f-flt after the first course of chemotherapy with complete response after treatment completion. * evaluate the correlation of early changes in tumor uptake of \^18f-flt with histologic response in biopsies obtained after 1 course of chemotherapy. * determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy. * determine if initial intensity of tumor uptake of \^18f-flt varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy. * determine if the tumor uptake of \^18f-flt during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy. * evaluate the role of tk1 on the kinetics of \^18 f-flt. * analyze serum. * research biomarkers of genomics, transcription, and proteomics. * evaluate the toxicity of \^18f-flt. outline: this is a multicenter study. patients receive 3'-deoxy-3'-(18f) fluorothymidine (\^18f-flt) iv and undergo positron emission tomography (pet) before the first and second courses of neoadjuvant chemotherapy. patients receiving bisequential chemotherapy undergo \^18f-flt-pet before the change in drugs (usually the fourth or fifth course). all patients undergo a final \^18f-flt-pet after the last chemotherapy course but before surgery. after completion of study therapy, patients are followed for 1 month.

Eligibility criteria:
disease characteristics: inclusion criteria: * histologically confirmed unilateral breast cancer * t2 or t3, any n, m0 * unifocal by mammography and ultrasound * negative for c-erbb2 by immunohistochemistry (ihc) * planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined * measurable disease by ultrasound * hormone receptor status not specified exclusion criteria: * bilateral disease * multifocal tumor * invasive grade i lobular cancer * metastatic disease * stage ≥ t4 disease * cutaneous invasion, major adherence, or inflammatory disease * tumor overexpressing c-erbb2 by ihc (her 2+++) * suspected clinical or radiological lesion (examined or not) patient characteristics: inclusion criteria: * ecog performance status 0-1 * female * menopausal status not specified * hematologic, hepatic, and renal function normal * not pregnant or nursing * fertile patients must use effective contraception exclusion criteria: * alcohol dependency or prior reaction to ethanol injection * impossible to receive study therapy due to geographical, social, or psychological reasons * prisoners or patients under supervision prior concurrent therapy: inclusion criteria: * see disease characteristics exclusion criteria: * participation in another concurrent therapeutic study with an experimental drug

Keywords: stage ii breast cancer stage iiia breast cancer