Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)
Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
Oncology Institute of Vojvodina
100 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
Summary
Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.
Eligibility
Inclusion Criteria9
- Breast-conserving surgery
- Invasive ductal carcinoma
- Age ≥ 50
- Tumor size ≤ 3 cm
- R0 resection
- Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
- pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
- Hormone receptor status - any
- Histological grade G1 or G2
Exclusion Criteria5
- Neoadjuvant systemic therapy
- TNBC (triple-negative breast cancer)
- Extensive intraductal component (EIC)
- Lymphovascular invasion (LVI)
- associated DCIS \> 2.5 cm in size or high nuclear grade
Interventions
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.
Locations(1)
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NCT05914831