Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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
-----------------
OBJECTIVES: is to investigate the impact of a short fractionated schedule given preoperatively on local control, cosmesis and breast fibrosis. To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT) on the basis of biological parameters, including the expression profile of the primary tumor, for both m-RNA as for micro-RNA, with first, a focus on radiotherapy responsiveness and second, on local recurrence rate, distant metastases and survival. proteomics will be studied in fine-needle aspiration samples. A classifier can be build (genomic or proteomic or any kind of molecular signature) to identify responders and non-responders quality of life OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks after completion of image-guided PAPBI, patients undergo surgery.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: biopsy
* Procedure: fine-needle aspiration
* Radiation: accelerated partial breast irradiation
* Radiation: image-guided radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer Must have undergone a sentinel node procedure prior to irradiation PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: accelerated partial breast irradiation<br>pre-operative radiation of the in situ tumor in the breast | Procedure: biopsy<br>* before treatment a biopsy will be taken to confirm breast cancer type<br>Procedure: fine-needle aspiration<br>* at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis<br>Radiation: accelerated partial breast irradiation<br> <br> Radiation: image-guided radiation therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence | Local recurrences should not exceed 4% at 5 years of follow-up | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast fibrosis | decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15% | 5 years | 
| cosmetic outcome | is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost. | 5 years | 
| Pathological response |  | 6 weeks after finishing iradiation treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, invasive breast cancer, adenocarcinoma of the breast