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

RECRUITINGPhase 2Sponsored by Oncology Institute of Vojvodina
Actively Recruiting
PhasePhase 2
SponsorOncology Institute of Vojvodina
Started2023-06-01
Est. completion2026-05-31
Eligibility
Age50 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 50 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

Breast CancerBreast Cancer FemaleCancer

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