Trial Information

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

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.