Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, male breast cancer
Study Type
Study Phase
Study Design
Masking: Open Label, Primary Purpose: Treatment
Name: DNA analysis Type: Genetic
Name: RNA analysis Type: Genetic
Name: gene expression analysis Type: Genetic
Name: laboratory biomarker analysis Type: Other
Name: biopsy Type: Procedure
Name: fine-needle aspiration Type: Procedure
Name: neoadjuvant therapy Type: Procedure
Name: therapeutic conventional surgery Type: Procedure
Name: accelerated partial breast irradiation Type: Radiation
Name: image-guided radiation therapy Type: Radiation
Overall Status
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.
Detailed Description

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both

- Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer

- Must have undergone a sentinel node procedure prior to irradiation


- Not specified


- See Disease Characteristics
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Status: Recruiting
Contact: Contact Person - 31-20-512-1714 - p.elkhuizen@nki.nl
Start Date
October 2009
The Netherlands Cancer Institute
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page