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.

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