Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy

Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy

Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast

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.

Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria

Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV

Histologic parameters: type, grade, mitotic index, CCIS , and microbiopsy embols after first course of chemotherapy (and on microbiopsy before therapeutic change of sequence in patients receiving bisequential chemotherapy)

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