Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighborhood. Nowadays accelerated partial breast irradiation (APBI) is recommended for highly selected patients. This prospective randomized study compares the targeted external beam APBI with commonly used accelerated whole-breast irradiation (WBI) in terms of feasibility, safety, tolerance, and cosmetic effects. It is designed as non-inferiority trial and its aim is to increase the level of evidence for establishment of external beam APBI in indicated patients into daily clinical practice.

Sex

Female

Minimum age

50 Years

Patients referred to medical attention for adjuvant radiotherapy of early-stage breast cancer at the Department of Radiation Oncology, Masaryk Memorial Cancer Institute (MMCI) were screened for eligibility. If all inclusion/exclusion criteria will be met, they were invited to participate in the present study.

Inclusion Criteria:

1. Age ≥50 years
2. Karnofsky index \> 70
3. Partial mastectomy (breast-conserving surgery)
4. DCIS G1/2 ≤ 2.5 cm with negative margins (≥ 3 mm) or invasive (non-lobular) luminal-like HER2 negative carcinoma ≤ 2 cm with negative margins (≥ 2 mm) without LVI
5. In the case of invasive carcinoma, performing of axillary dissection (≥6 negative lymph nodes) or negative sentinel node biopsy

Exclusion Criteria:

1. Prior to other chest or breast surgery (including breast reconstruction), the absence of surgical clips in the tumor bed
2. Prior ipsilateral chest or breast radiotherapy
3. Neoadjuvant systemic therapy
4. Adjuvant chemotherapy
5. Multifocal or multicentric involvement
6. BRCA 1 or 2 mutations or known mutations in other high penetrance genes
7. Any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risks for the performance of radiotherapy including claustrophobia or jactation
8. Any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
9. Pregnancy or breastfeeding
10. Inability or unwillingness of the subject to sign written informed consent

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