Pre- Versus Postoperative Accelerated Partial Breast Irradiation

Study Overview
=================
Brief Summary
-----------------
Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

Detailed Description
-----------------
Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy

Official Title
-----------------
Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients

Conditions
-----------------
Breast Cancer, Cancer of the Breast, Neoplasms, Breast

Intervention / Treatment
-----------------
* Radiation: partial breast irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients ≥ 51 years clinical stage tumor-1-2 (≤ 3 cm) cN0 Grade I or grade II (biopsy) Histologically proven invasive ductal adenocarcinoma Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision to be determined by the participating centre) World Health Organization performance status ≤ 2 Life expectancy ≥ 5 years Written informed consent Exclusion Criteria: Distant metastases Lobular invasive carcinomas Pure Ductal Carcinoma in situ (DCIS) without invasive tumor Grade III in biopsy Triple negative tumors HER2neu positive tumors Lymphvascular invasion in biopsy TNM pathologic stage N1-3 pN+ (micro- or macrometastases) Multicentric / multifocal disease on mammogram or MRI Diffuse calcifications on mammogram (Birads 3, 4 or 5) Prior treatment for the protocol tumor (no surgery, no neoadjuvant chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy) Previous contralateral breast cancer Other neoplasms in the last 5 years with the exception of: Basal cell carcinoma of the skin Adequately treated carcinoma in situ of the cervix Planned oncoplastic resection with tissue displacement No social security affiliation/health insurance Participation in another clinical trial that interferes with the locoregional treatment of this protocol It is expected that dosimetric constraints cannot be met, ie, lung/heart constraints or if the ratio PTV/ipsilateral breast >30%

Ages Eligible for Study
-----------------
Minimum Age: 51 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy in arm 1<br>pre-operative accelerated partial breast irradiation | Radiation: partial breast irradiation<br>* irradiation<br>* Other names: accelerated breast irradiation;|
| Active Comparator: radiotherapy in arm 2<br>post-operative accelerated partial breast irradiation | Radiation: partial breast irradiation<br>* irradiation<br>* Other names: accelerated breast irradiation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | cosmetic effect will be measured by comparing the treated breast with the contralateral breast. Cosmetic effect will be scored in three different ways: by digital photographs, patient's questionnaires and specialist's questionnaires. These data will result in an overall cosmetic outcome, scored as excellent, good, fair or poor. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response | pathologic response will be measured in the removed tissue | 6 weeks | 
| postoperative complications | The expected acute surgical complication rate is approximately 16%. A stopping rule is set at 15% for complications that require hospitalization (including intravenous antibiotics) and re-surgery | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer