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Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

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…

ClinicalTrials.gov IDNCT05914831
PhasePHASE2
Enrollment100
SponsorOncology Institute of Vojvodina
Age50 Years
SexFEMALE
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Conditions studied

Breast Cancer Female

About this study

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.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.