Trial Information

Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity

OBJECTIVES:

- To develop a gene expression profile that predicts the breast cancer radiosensitivity
in patients with early-stage breast cancer treated with neoadjuvant image-guided
preoperative accelerated partial-breast irradiation followed by surgery.

- To further design optimal treatment strategies for individual breast cancer patients
treated with breast-conserving therapy (BCT).

- To assess the radio-induced genetic alterations on the surgical post-radiation specimen
compared to the tumor response 6 weeks after the end of radiotherapy.

- To study the early changes in gene profiling.

- To evaluate the early functional-imaging modifications.

OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation
(PAPBI) 10 times over 12 days (using cone-beam CT linear accelerator for accurate tumor
delineation and control of accurate radiation-dose delivery to the tumor). Beginning 6 weeks
after completion of image-guided PAPBI, patients undergo surgery.

Patients undergo biopsy and fine-needle aspiration prior to and during radiotherapy and at
the time of surgery. Gene expression profiling from RNA and DNA isolated from these samples
are used to identify breast cancer radiosensitivity. biopsies and fine needle aspiration
taken of the tumor before, during radiotherapy and at time of operation. The mRNA gene
expression profiles, the miRNA expression profiles and the DNA copy number changes are
correlated with response to radiotherapy (defined as pathologic response at the time of the
lumpectomy [i.e. 6 weeks after the completion of the PAPBI]).

Fresh-frozen tumor tissue, blood, and urine samples are also collected to assess the
radio-induced genetic alterations; to study the early changes in gene profiling; and to
evaluate the early functional-imaging modifications.