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.
Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
irradiation
Institut Curie
Saint-Cloud, France
Institut Gustave-Roussy
Villejuif, France
Antoni van Leeuwenhoek
Amsterdam, Netherlands
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands
Champilamaud Cancer Center
Lisbon, Portugal
University General Hospital Valencia-Erasa
Valencia, Spain
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.
Time frame: 3 years
tumor response
pathologic response will be measured in the removed tissue
Time frame: 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
Time frame: 6 weeks
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